Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

March 2, 2026 updated by: Juno Therapeutics, a Subsidiary of Celgene

An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C1
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
          • Abi Vijenthira, Site 0112
          • Phone Number: 4167901284
      • Toronto, Ontario, Canada, M5G 2C1
        • Withdrawn
        • Local Institution - 0112
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amitkumar Mehta, MD
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama Birmingham
        • Contact:
          • Amitkumar Mehta, Site 0006
          • Phone Number: 205-996-8400
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Recruiting
        • Banner MD Anderson Cancer Center
        • Contact:
          • Matthew Ulrickson, Site 0043
          • Phone Number: 480-256-4749
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Tanya Siddiqi, Site 0007
          • Phone Number: 626-256-4673
      • La Jolla, California, United States, 92093
        • Recruiting
        • UC San Diego Moores Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas J Kipps, MD, PhD
      • La Jolla, California, United States, 92093
        • Recruiting
        • University Of California San Diego Moores Cancer Center
        • Contact:
          • Thomas Kipps, Site 0025
          • Phone Number: 858-822-6135
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California, Los Angeles
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herbert Eradat, MD, MS
      • Los Angeles, California, United States, 90095
        • Active, not recruiting
        • Local Institution - 0059
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Principal Investigator:
          • Lawrence Kaplan, MD
        • Contact:
      • San Francisco, California, United States, 94143
        • Active, not recruiting
        • Local Institution - 0010
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Luke Mountjoy, Site 0111
    • Delaware
      • Newark, Delaware, United States, 19713
        • Withdrawn
        • Local Institution - 0110
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center
        • Contact:
        • Principal Investigator:
          • Pashna Munshi, MD
      • Washington D.C., District of Columbia, United States, 20007
        • Completed
        • Local Institution - 0085
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic - Jacksonville
        • Contact:
          • Mohamed Kharfan-Dabaja, Site 0080
          • Phone Number: 904-953-2000
      • Jacksonville, Florida, United States, 32224
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Active, not recruiting
        • Local Institution - 0019
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • The Blood and Marrow Transplant Group of Georgia (BMTGA)
        • Contact:
        • Principal Investigator:
          • Scott R Solomon, MD
        • Contact:
      • Atlanta, Georgia, United States, 30322
        • Not yet recruiting
        • Local Institution - 0104
        • Contact:
          • Site 0104
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
          • Peter Riedell, Site 0016
          • Phone Number: 773-702-8412
      • Chicago, Illinois, United States, 60611
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Contact:
          • Shuo Ma, Site 0003
          • Phone Number: 312-927-7884
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan St. Francis Health - Indiana Blood and Marrow Transplantation (IBMT)
        • Contact:
          • Anand Tandra, Site 0105
          • Phone Number: 317-871-0000
    • Kansas
      • Wichita, Kansas, United States, 67124
        • Not yet recruiting
        • Local Institution - 0107
        • Contact:
          • Site 0107
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Healthcare - Norton Cancer Institute
        • Contact:
          • Don Stevens, Site 0064
          • Phone Number: 502-899-3366
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Completed
        • Local Institution - 0027
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Jacob D Soumerai, MD
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
        • Principal Investigator:
          • Jon Arnason, MD
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Active, not recruiting
        • Local Institution - 0005
      • Boston, Massachusetts, United States, 02215
        • Active, not recruiting
        • Local Institution - 0015
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Contact:
          • Monalisa Ghosh, Site 0084
          • Phone Number: 734-936-4000
      • Ann Arbor, Michigan, United States, 48109-5362
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Monalisa Ghosh, MD
        • Contact:
          • U of M Cancer Answerline
          • Phone Number: 800-865-1125
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute
        • Principal Investigator:
          • Abhinav Deol, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Active, not recruiting
        • Local Institution - 0062
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Contact:
          • Saad Kenderian, Site 0054
          • Phone Number: 507-284-2511
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
          • Julie Vose, Site 0008
          • Phone Number: 402-559-5600
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan-Kettering Cancer Center (MSKCC) - Basking Ridge
        • Contact:
          • Jae Park, Site 0001
          • Phone Number: 646-608-3743
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • Astera Cancer Care
        • Contact:
          • Edward Licitra, Site 0114
          • Phone Number: 732-390-7750
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Center
        • Principal Investigator:
          • Tatyana Feldman, MD
        • Contact:
      • Hackensack, New Jersey, United States, 07601-2191
        • Recruiting
        • John Theurer Cancer Center
        • Contact:
          • Tatyana Feldman, Site 0038
          • Phone Number: 973-699-2835
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Atlantic Health System / Morristown Medical Center
        • Contact:
          • Mohamad Cherry, Site 0106
          • Phone Number: 973-971-7906
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roger Strair, MD, PhD
      • New Brunswick, New Jersey, United States, 08903
        • Completed
        • Local Institution - 0077
    • New York
      • New York, New York, United States, 10032
        • Withdrawn
        • Columbia University Medical Center
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medical College
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koen Van Besien, MD, PhD
      • New York, New York, United States, 10021
        • Active, not recruiting
        • Local Institution - 0035
      • New York, New York, United States, 10032
        • Completed
        • Local Institution - 0026
      • Stony Brook, New York, United States, 11794-8160
        • Recruiting
        • Stony Brook University
        • Contact:
          • Michael Schuster, Site 0089
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Danielle M Brander, MD
      • Durham, North Carolina, United States, 27705
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Danielle Brander, Site 0030
          • Phone Number: 919-684-8964
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Cleveland Medical Center
        • Contact:
          • Molly Gallogly, Site 0078
      • Cleveland, Ohio, United States, 44106-5061
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Comprehensive Cancer Center
        • Contact:
          • Jennifer Woyach, Site 0031
          • Phone Number: 614-688-7942
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Peggy and Charles Stephenson Cancer Center
        • Contact:
          • Adam Asch, Site 0082
          • Phone Number: 405-271-4022
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center (Stephenson Cancer Center)
        • Principal Investigator:
          • Adam Asch, MD
        • Contact:
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Completed
        • Local Institution - 0098
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania Perelman Center for Advanced Medicine
        • Contact:
        • Principal Investigator:
          • Stephen Schuster, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Matthew Carabasi, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania - Perelman Center for Advanced Medicine
        • Contact:
          • Stephen Schuster, Site 0088
          • Phone Number: 215-614-1846
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University - Clinical Research Institute
        • Contact:
          • Usama Gergis, Site 0032
          • Phone Number: 917-698-4310
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
          • Linda Fukas
        • Contact:
        • Principal Investigator:
          • Kathleen Dorritie, MD
      • Pittsburgh, Pennsylvania, United States, 15232
        • Active, not recruiting
        • Local Institution - 0029
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute - Tennessee Oncology
        • Contact:
          • Krish Patel, Site 0119
          • Phone Number: 206-215-2338
    • Texas
      • Dallas, Texas, United States, 75390
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Baylor University Medical Center
        • Contact:
          • Houston E Holmes III, MD, FACP
          • Phone Number: 214-370-1077
        • Principal Investigator:
          • Houston E Holmes III, MD, FACP
      • Dallas, Texas, United States, 75390
        • Completed
        • Local Institution - 0083
      • Dallas, Texas, United States, 75426
        • Completed
        • Local Institution - 0079
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas - MD Anderson Cancer Center
        • Contact:
          • William Wierda, Site 0002
          • Phone Number: 713-745-0428
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:
        • Principal Investigator:
          • William G Wierda, MD, PhD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute
        • Principal Investigator:
          • Deborah Stephens, DO
        • Contact:
      • Salt Lake City, Utah, United States, 84112
        • Active, not recruiting
        • Local Institution - 0028
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • Withdrawn
        • Local Institution - 0113
      • Richmond, Virginia, United States, 23298
        • Withdrawn
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23298
        • Completed
        • Local Institution - 0087
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:
        • Principal Investigator:
          • David Maloney, MD, PhD
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Center Alliance
        • Contact:
          • Jordan Gauthier, Site 0018
          • Phone Number: 206-667-2713
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Nirav Shah, MD
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital BMT Medical College of Wisconsin
        • Contact:
          • Nirav Shah, Site 0055
          • Phone Number: 414-805-4691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of:

    1. CLL with an indication for treatment based on the Investigator's opinion and measurable disease, or
    2. SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy and DEME cohort) must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy.

  • Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:

    1. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and high-risk features must have failed at least 2 lines of prior therapy.
    2. Monotherapy cohorts EXCEPT DEME cohort: Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
    3. DEME cohort ONLY: Subjects with relapsed or refractory CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i.

  • Subjects in the ibrutinib + JCAR017 combination therapy cohort must either:

    1. be receiving ibrutinib and progressing at the time of study enrollment
    2. be receiving ibrutinib for at least 6 months with a response less than complete response/remission (CR) and have high-risk features as defined in inclusion criterion 5a
    3. have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
    4. have previously received ibrutinib and have no contraindications to restarting ibrutinib
  • Eastern Cooperative Oncology Group performance status of ≤ 1
  • Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy

  • Adequate organ function, defined as:

    1. Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min
    2. Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
    3. Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air
    4. Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
  • Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
  • If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
  • Subjects in ibrutinib + JCAR017 combination cohort must have progressed on a BTKi and have received prior therapy with venetoclax

  • Subjects in venetoclax + JCAR017 combination cohort must:

    1. have failed at least 1 prior line of therapy, including failed BTKi therapy or have been deemed ineligible to receive BTKi
    2. be venetoclax naive (required for dose expansion) or
    3. if prior venetoclax (only for dose escalation)
    4. have no contraindictions to re-initiation of venetoclax based on prior intolerance and have had at least 6 months elapsed since the last dose of venetoclax, if either, best response was stable disease, or subject experienced disease progression on venetoclax, or within 6 months of venetoclax discontinuation
  • subjects in the venetoclax + JCAR017 combination must have hemoglobin >=9 g/dL, absolute neutrophil count >=500mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
  • must have diagnosis of CLL or SLL with an indication for treatment based on the investigator's opinion and measurable disease (any of the following measurable lymph nodes ≥1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly) and demonstration of CLL cells in the peripheral blood by flow cytometry

Exclusion Criteria:

  • Subjects with known active central nervous system (CNS) involvement by malignancy. Those with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
  • History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.)
  • Subjects with Richter's transformation
  • Prior treatment with any gene therapy product
  • Active hepatitis B, active hepatitis C, or active human immunodeficiency virus (HIV) infection
  • Systemic fungal, bacterial, viral, or other infection that is not controlled
  • Presence of acute or extensive chronic graft versus host disease (GVHD)
  • History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease
  • History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease,cerebral edema, or psychosis
  • Pregnant or nursing (lactating) women

  • Use of any of the following medications or treatments within the noted time prior to leukapheresis:

    1. Alemtuzumab within 6 months prior to leukapheresis
    2. Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis
    3. Cladribine within 3 months prior to leukapheresis
    4. Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis
    5. Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis
    6. Fludarabine within 4 weeks prior to leukapheresis
    7. GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL 6R]) within 4 weeks prior to leukapheresis
    8. Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis
    9. Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis
    10. Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis
    11. Venetoclax within 4 days prior to leukapheresis
    12. Idelalisib or duvelisib within 2 days prior to leukapheresis
    13. Lenalidomide or covalent and non-covalent BTKi within 1 day prior to leukapheresis
    14. Experimental agents, including off-label use of approved drugs (with the exception of acalabrutinib which may be continued up to the day before leukapheresis), within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol
  • Progressive vascular tumor invasion, thrombosis, or embolism
  • Deep vein thrombosis or embolism not managed on a stable regimen of anticoagulation
  • Use of any of the following medications or treatments within the noted time prior to leukapheresis lenalidomide or acalabrutinib within 1 day prior to leukapheresis experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis.
  • Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation
  • For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 JCAR017 monotherapy
Subjects will be assigned to receive JCAR017 (lisocabtagene maraleucel)
Biological: JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + ibrutinib
Subjects receiving ibrutinib at baseline will be assigned to receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm + ibrutinib
Biological: JCAR017 (lisocabtagene maraleucel) + ibrutinib
Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 2 JCAR017 monotherapy
Subjects will receive JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm
Biological: JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
Experimental: Phase 1 JCAR017 + venetoclax
Subjects will receive venetoclax as bridging anticancer therapy until lymphodepletion chemotherapy/ JCAR017 (lisocabtagene maraleucel) at the recommended dose from the Phase 1 monotherapy arm. After JCAR017 infusion subjects will receive venetoclax until Day 90.
Biological: JCAR017 (lisocabtagene maraleucel) + venetoclax
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.
Experimental: Phase 2 JCAR017 Double-Exposed Monotherapy Expansion (DEME)
Subjects will receive JCAR017 monotherapy
Biological: JCAR017 (lisocabtagene maraleucel)
Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging anticancer therapy for disease control. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm
Time Frame: Through post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 + ibrutinib using iwCLL 2018 guidelines
Through post treatment up to Month 48
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm
Time Frame: Through post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 + venetoclax using iwCLL 2018 guidelines
Through post treatment up to Month 48
Phase 1 JCAR017 monotherapy arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 monotherapy arm: laboratory abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose escalation therapy arm: laboratory abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: laboratory abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 2 JCAR017 monotherapy expansion arm
Time Frame: Through post treatment up to Month 48
Proportion of subjects who have CR after treatment with JCAR017 using iwCLL 2018 guidelines
Through post treatment up to Month 48
Phase 2 JCAR017 Double exposed monotherapy expansion arm: overall response rate (ORR)
Time Frame: Up to approximately 24 months
ORR defined as the rate of complete response/remission (CR) [including complete response/remission with incomplete marrow recovery (Cri)] plus PR [including nodular partial response (nPR)] based on Independent Review Committee (IRC) assessment using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 guidelines
Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: ORR
Time Frame: Up to 48 months post treatment
Defined as the rate of CR (including CRi)
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: laboratory abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD negative response rate in peripheral blood
Time Frame: Up to 48 months post treatment
Proportion of subjects who achieve MRD CR
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: MRD-negative CR rate in peripheral blood
Time Frame: Up to 48 months post treatment
Proportion of subjects who achieve MRD CR
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of response (DOR)
Time Frame: Up to 48 months post treatment
Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Duration of complete response (DoCR)
Time Frame: Up to 48 months post treatment
Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to response (TTR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: PFS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: OS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the date of death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and ibrutinib combination dose expansion therapy arm: Time to complete response (TTCR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: ORR
Time Frame: Through post treatment Day 90
Defined as the rate of CR (including CRi)
Through post treatment Day 90
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subject experiencing adverse events
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: lab abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: MRD-negative response rate in peripheral blood
Time Frame: Up to 48 months post treatment
Proportion of subjects who achieve MRD CR
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose escalation therapy arm: MRD-negative CR rate in peripheral blood
Time Frame: Through post treatment Day 90
Proportion of subjects who achieve MRD CR
Through post treatment Day 90
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of response (DOR)
Time Frame: Up to 48 months post treatment
Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Duration of complete response (DoCR)
Time Frame: Up to 48 months post treatment
Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to response (TTR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: Time to complete response (TTCR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: PFS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 1 JCAR017 and venetoclax combination dose expansion therapy arm: OS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the date of death due to any cause
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: adverse events
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing adverse events
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: laboratory abnormalities
Time Frame: Up to 48 months post treatment
Proportion of subjects experiencing laboratory abnormalities
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: ORR
Time Frame: Up to 48 months post treatment
Defined as the rate of CR (including CRi)
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: MRD negative response rate in peripheral blood
Time Frame: Up to 48 months post treatment
Proportion of subjects who achieve MRD CR
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood
Time Frame: Up to 48 months post treatment
Proportion of subjects who achieve MRD CR
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of response (DOR)
Time Frame: Up to 48 months post treatment
Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Duration of complete response (DoCR)
Time Frame: Up to 48 months post treatment
Defined as the time from first CR or CRi to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Time to response (TTR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Time to complete response (TTCR)
Time Frame: Up to 48 months post treatment
Defined as the interval from JCAR017 infusion to the first documentation of CR
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: PFS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: OS
Time Frame: Up to 48 months post treatment
Defined as the time from JCAR017 infusion to the date of death due to any cause
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Health-related quality of life (HRQoL) questionnaire
Time Frame: Up to 48 months post treatment
Change from baseline in HRQoL assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: HRQoL questionnaire
Time Frame: Up to 48 months post treatment
Change from baseline in HRQoL assessed using the EORTC chronic lymphocytic leukemia (CLL)-specific module QLQ-CLL-17
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: Health economics and outcomes research (HEOR) questionnaire
Time Frame: Up to 48 months post treatment
Change from baseline in measurement of health utility values using EuroQol instrument EQ-5D-5L
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire
Time Frame: Up to 48 months post treatment
Proportion of participants with intensive care unit (ICU) inpatient days
Up to 48 months post treatment
Phase 2 JCAR017 Monotherapy Expansion Arm: HEOR questionnaire
Time Frame: Up to 48 months post treatment
Proportion of participants with non-ICU inpatient days
Up to 48 months post treatment
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: adverse events
Time Frame: Up to approximately 24 months
Proportion of subjects experiencing adverse events
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: laboratory abnormalities
Time Frame: Up to approximately 24 months
Proportion of subjects experiencing laboratory abnormalities
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Duration of response (DOR)
Time Frame: Up to approximately 24 months
Defined as the time from first response (CR, CRi, nPR, or PR) to the earlier date of PD or death due to any cause
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: CR rate
Time Frame: Up to approximately 24 months
Defined as the rate of CR (including CRi) based on IRC assessment using iwCLL 2018 guidelines
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative response rate in peripheral blood
Time Frame: Up to approximately 24 months
Proportion of subjects who achieve MRD negative status
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: MRD-negative CR rate in peripheral blood
Time Frame: Up to approximately 24 months
Proportion of subjects who achieve MRD-negative CR
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to response (TTR)
Time Frame: Up to approximately 24 months
Defined as the interval from JCAR017 infusion to the first documentation of CR, CRi, nPR, or PR
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Time to complete response (TTCR)
Time Frame: Up to approximately 24 months
Define as the interval from JCAR017 infusion to the first documentation of CR
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Progression free survival (PFS)
Time Frame: Up to approximately 24 months
Defined as the time from JCAR017 infusion to the earlier date of PD or death due to any cause
Up to approximately 24 months
Phase 2 JCAR017 Double-Exposed Monotherapy Expansion Arm: Overall Survival (OS)
Time Frame: Up to approximately 24 months
Defined as the time from JCAR017 infusion to the date of death due to any cause
Up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Juno Therapeutics, a Subsidiary of Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2017

Primary Completion (Estimated)

November 26, 2027

Study Completion (Estimated)

November 26, 2027

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

November 2, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 017004
  • TRANSCEND-CLL-004 (Other Identifier: Juno Therapeutics, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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