First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma (EPCORE™ NHL-1)

A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20):

• The dose schedule for epcoritamab
• The side effects seen with epcoritamab
• What the body does with epcoritamab once it is administered
• What epcoritamab does to the body once it is administered
• How well epcoritamab works against relapsed and/or refractory B-cell lymphoma

The trial consists of 3 parts:

• a dose-escalation part [Phase 1, first-in-human (FIH)]
• an expansion part (Phase 2a)
• a dose-optimization part (OPT) (Phase 2a)

The trial time for each participant depends on which trial part the participant enters:

• For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).
• For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant).

Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends.

All participants will receive active drug, and no participants will be given placebo.

Study Overview

• Status: Active, not recruiting
• Conditions: Small Lymphocytic Lymphoma (SLL); DLBCL; Primary Mediastinal Large B-cell Lymphoma (PMBCL); MCL; Marginal Zone Lymphoma (MZL); High-grade B-cell Lymphoma (HGBCL); FL
• Intervention / Treatment: Biological: Epcoritamab

Detailed Description

The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma.

In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab.

The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with:

• Diffuse large B-cell lymphoma (DLBCL)
• Follicular lymphoma (FL)
• Mantle cell lymphoma (MCL)

All participants will receive epcoritamab at the RP2D.

• Study Type: Interventional
• Enrollment (Actual): 666
• Phase: Phase 2; Phase 1

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Genmab Trial Information; Phone Number: +45 70202728; Email: clinicaltrials@genmab.com

Study Locations

• Australia
  • Clayton, Australia
    • Monash Health
  • Concord, Australia
    • Concord Hospital
  • Fitzroy, Australia
    • St. Vincent Hospital
  • Herston, Australia
    • Royal Brisbane and Women's Hospital
  • Hobart, Australia
    • Royal Hobart Hospital RHH
  • Kogarah, Australia
    • St. George Hospital
  • Malvern, Australia
    • Cabrini Hospital
  • Nedlands, Australia
    • Sir Charles Gairdner Hospital
  • Southport, Australia
    • Gold Coast Hospital
  • Sydney, Australia
    • Westmead Hospital
• Canada
  • Calgary, Canada
    • Tom Baker Cancer Care
  • Toronto, Canada
    • Toronto-Sunnybrook Regional Cancer Ctr
• Denmark
  • Copenhagen, Denmark
    • Rigshospitalet
  • Odense, Denmark, 5000 C
    • Odense University Hospital
  • Vejle, Denmark
    • Vejle Hospital
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Tampere, Finland
    • Tampere University Hospital
• France
  • Créteil, France
    • Hopital Henri Mondor
  • Montpellier, France
    • CHU Montpellier
  • Paris, France
    • Hôspital Saint-Louis
  • Pierre-Bénite, France
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud
  • Rouen cedex, France
    • Centre Henri Becquerel
  • Tours, France
    • CHU de Tours-Hopital Bretonneau
• Germany
  • Berlin, Germany
    • Charite - Universitaetsmedizin Berlin
  • Berlin, Germany
    • Klinik fur Innere Medizin Hamatologie and Onkologie
  • Cologne, Germany
    • Universitaetsklinikum Koeln
  • Essen, Germany
    • Universitaetsklinikum Essen
  • Mainz, Germany
    • Johannes Gutenberg University
  • München, Germany
    • Der Universität Munchen Medizinische Klinik III LMU
• Italy
  • Alessandria, Italy
    • Ao Ss Antonio E Biagio Alessandria
  • Bologna, Italy
    • Policlinico S. Orsola-Ematologia LA Seragnoli
  • Candiolo, Italy
    • Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia
  • Meldola, Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
  • Milan, Italy
    • Irccs Ospedale San Raffaele
• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Goyang-si, Korea, Republic of
    • National Cancer Center
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Severance Hospital, Yonsei University
• Netherlands
  • Amsterdam, Netherlands
    • VU University Medical Center
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands
    • Erasmus MC Cancer Institute
  • Utrecht, Netherlands
    • Universitair Medisch Centrum Utrecht
• Poland
  • Bydgoszcz, Poland
    • Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
  • Gdańsk, Poland
    • Uniwersyteckie Centrum Kliniczne
  • Kraków, Poland
    • Pratia-McM
  • Słupsk, Poland
    • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
  • Warszawa, Poland
    • Maria Sklodowska-Curie Memorial Cancer Center and Institute
  • Wrocław, Poland
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego
• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • Singapore General Hospital
• Spain
  • Badalona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain
    • Hospital Universitario Vall Dhebron
  • Barcelona, Spain
    • Institut Catala de Oncologia
  • Madrid, Spain
    • Hospital Universitario Fundacin Jimnez Daz
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Lund, Sweden
    • Skåne University Hospital
  • Stockholm, Sweden
    • Karolinska University Hospital Huddinge
  • Uppsala, Sweden
    • Akademiska sjukhuset Uppsala University Hospital
• United Kingdom
  • Manchester, United Kingdom
    • The Christie NHS Foundation Trust
  • Plymouth, United Kingdom
    • Plymouth University School of Medicine- Derriford Hospital
  • Southampton, United Kingdom
    • University Hospital Southampton NHS Foundation Trust
  • Sutton, United Kingdom
    • Royal Marsden NHS Foundation Trust
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Arizona Mayo Clinic
  • California
    • San Francisco, California, United States, 94117
      • University of California at San Francisco
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center and Research Institute
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48334
      • Barbara Ann Karmanos Cancer Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97210
      • OHSU Knight Cancer Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Hillman Cancer Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Southwestern
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Main Inclusion Criteria - Escalation Part (recruitment completed)

• Documented CD20+ mature B-cell neoplasm

  1. DLBCL - de novo or transformed
  2. HGBCL
  3. PMBCL
  4. FL
  5. MCL
  6. SLL
  7. MZL (nodal, extranodal or mucosa associated)
• Relapsed and/or refractory disease following treatment with an anti-CD20 monoclonal antibody (e.g. rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
• Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2.
• Participants must have measurable disease by CT, MRI or Positron emission tomography-Computed tomography (PET-CT) scan
• Acceptable renal function.
• Acceptable liver function.

Main Inclusion Criteria - Expansion & Dose-OPT Parts

• Documented CD20 positive mature B cell neoplasm or CD20+ MCL.
• DLBCL, de novo or transformed (including double hit or triple hit).
• PMBCL
• FL grade 3B
• Histologic confirmed FL
• MZL
• SLL
• MCL (prior BTKi or intolerant to BTKi)
• At least 2 therapies including an anti-CD20 monoclonal antibody containing chemotherapy combination regimen.
• Either failed prior autologous hematopoietic stem cell transplantation (HSCT) or ineligible for autologous stem cell transplantation due to age or comorbidities.
• At least 1 measurable site of disease based on CT, MRI or PET-CT scan with involvement of 2 or more clearly demarcated lesions and or nodes.

Main Exclusion Criteria - All Parts

• Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
• Known past or current malignancy other than inclusion diagnosis.
• AST, and/or ALT >3 × upper limit of normal.
• Total bilirubin >1.5 × upper limit of normal, unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.
• Estimated Creatinine clearance (CrCl) <45 mL/min.
• Known clinically significant cardiovascular disease.
• Ongoing active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic treatment (excluding prophylactic treatment). Past COVID-19 infection may be a risk factor.
• Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy.
• Seizure disorder requiring therapy (such as steroids or anti-epileptics).
• Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20.
• Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to first epcoritamab administration.
• Eligible for curative intensive salvage therapy followed by high dose chemotherapy with HSCT rescue.
• Autologous HSCT within 100 days prior to first epcoritamab administration, or any prior allogeneic HSCT or solid organ transplantation.
• Active hepatitis B (DNA PCR-positive) or hepatitis C (RNA PCR-positive infection). Participants with evidence of prior HBV but who are PCR-negative are permitted in
• Known human immunodeficiency virus (HIV) infection.
• Exposed to live or live attenuated vaccine within 4 weeks prior to signing Informed consent form (ICF).
• Pregnancy or breast feeding.
• Participant is known or suspected of not being able to comply with the study protocol or has any condition for which, participation would not be in the best interest of the participant.
• Contraindication to all uric acid lowering agents.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Epcoritamab; Epcoritamab will be administered by subcutaneous injections in cycles of 28 days.	Biological: Epcoritamab; Administered as specified in the treatment arm.; Other Names: GEN3013; DuoBody®-CD3xCD20; EPKINLY™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Escalation: Dose Limiting Toxicity (DLT)	To determine the MTD and/or RP2D to be studied in the Expansion part. DLT will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.	During the first cycle (28 days) in each Dose-OPT Part DLBCL, FL and MCL
Dose-Escalation: Number of Participants with Adverse Events (AEs)	An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.	From first dose until the end of the safety follow-up period (Up to 1 year)
Expansion and Dose-OPT MCL: Overall Response Rate (ORR)	ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria as assessed by independent review committee (IRC).	Up to 1.5 years
Dose-OPT DLBCL, FL and MCL: Percentage of Participants with =>Grade 2 Cytokine Release Syndrome (CRS) Events and All Grade CRS Events	CRS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria.	From first dose until 7 days after second full dose (Day 28 for DLBCL; Day 35 for FL; Day 28-35 for MCL)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-Escalation: Number of Participants with Anti-lymphoma Activity of Epcoritamab	Anti-lymphoma activity will be evaluated as number of participants with resolution of constitutional symptoms, reduction in tumor size, objective, and best response (ORR, CR and PR).	Up to 1 year
Dose-Escalation: DOR	DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier as assessed by the investigator.	Up to 1 year
Expansion: DOR	DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by IRC.	Up to 1.5 years
Expansion Part: Changes in Lymphoma Symptoms as Measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)	Change from baseline in health-related quality of life over time and in relation to treatment will be evaluated using FACT-Lym scale.	Up to 1.5 year
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Following First Full Dose	CRS will be graded based on ASTCT criteria.	Up to 1.5 years
Dose-OPT DLBCL and FL: Percentage of Participants with >=Grade 2 CRS Events and All Grade CRS Events Overall	CRS will be graded based on ASTCT criteria.	Up to 1.5 years
Dose-OPT DLBCL and FL: ORR	ORR is defined as the percentage of participants achieving CR or PR assessed by investigator.	Up to 1.5 years
Dose-OPT DLBCL and FL: CR Rate	CR rate is defined as the percentage of participants with CR assessed by investigator.	Up to 1.5 years
Dose-OPT DLBCL and FL: Duration of CR (DoCR)	DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier assessed by investigator.	Up to 1.5 years
Dose-OPT DLBCL and FL: Progression-Free Survival (PFS)	PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier assessed by investigator.	Up to 1.5 years
Dose-OPT DLBCL and FL: DLT	To determine the MTD and/or RP2D to be studied in the expansion part. DLT will be graded according to NCI-CTCAE version 5.0.	During the first cycle (28 days) in each Dose-OPT Part (DLBCL, FL and MCL)
Dose-OPT MCL: Time to Complete Response (TTCR)	TTCR is defined as the time from Day 1 of Cycle 1 to first documentation of complete response based on Lugano criteria and LYRIC as assessed by IRC.	Up to 1.5 years
Dose-OPT DLBCL, FL and MCL: DOR	DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on Lugano criteria assessed by investigator.	Up to 1.5 years
Dose-Escalation and Dose-OPT DLBCL, FL and MCL: Pre-dose Values of Epcoritamab		Predose and postdose at multiple timepoints of each Cycle (Cycle length=28 days)
Dose-Escalation, Expansion Part and Dose-OPT MCL: PFS	PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on Lugano criteria assessed by IRC.	Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (MCL): 1.5 years
Expansion and Dose-OPT MCL: CR Rate	CR rate is defined as the percentage of participants with CR based on Lugano criteria as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR	DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on Lugano criteria as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: ORR	ORR is defined as the percentage of participants achieving CR or PR based on lymphoma response to immunomodulatory therapy criteria (LYRIC) as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: Time to Response (TTR)	TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on Lugano criteria as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: CR Rate	CR rate is defined as the percentage of participants with CR based on LYRIC as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: PFS	PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause, whichever occurs earlier based on LYRIC assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: DOR	DOR is defined as the time from the first documentation of response (CR or PR) to the date of PD or death, whichever occurs earlier based on LYRIC assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: DoCR	DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs earlier based on LYRIC as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT MCL: TTR	TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (PR or better) earlier based on LYRIC as assessed by IRC.	Up to 1.5 years
Expansion and Dose-OPT DLBCL, FL and MCL: Number of Participants with AEs	An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.	Up to 7 years and 6 months
Expansion and Dose-OPT DLBCL, FL and MCL: Rate of Minimal Residual Disease (MRD) Negativity	MRD is defined as percentage of participants with at least 1 MRD negative result.	Up to 1.5 years
All Parts: Number of Participants with CRS Events	CRS will be graded based on ASTCT criteria.	Up to Day 1 of Cycle 12 (Cycle length=28 days)
All Parts: Immunophenotyping for Absolute T-cell and B-cell	Number of cells will be reported for absolute T-cells and B-cells.	Up to Day 1 of Cycle 12 (Cycle length=28 days)
All Parts: T-Cell Activation and Exhaustion Marker	T-Cell Activation and Exhaustion Marker (CD69, CD25, and PD-1) will be measured using flow cytometry.	Up to 7 years and 6 months
All Parts: Total Body Clearance of Epcoritamab from the Plasma (CL)		Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
All Parts: Area under Curve (AUC) of Epcoritamab		Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
All Parts: Maximum (peak) Plasma Concentration (Cmax) of Epcoritamab		Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
All Parts: Time to Reach Cmax of Epcoritamab		Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
All Parts: Half Life of Epcoritamab (t1/2)		Predose and postdose at multiple timepoints of each cycle (Cycle length=28 days)
All Parts: Number of Participants with Anti-drug Antibody (ADA)	Plasma samples will be screened for antibodies binding to epcoritamab, and for confirmed positive samples, the titer against the two specific arms of epcoritamab will be reported.	Up to 7 years and 6 months
All Parts: Time to Next Anti-lymphoma Therapy (TTNT)	TTNT is defined as the time from Day 1 of Cycle 1 to first recorded administration of subsequent anti-lymphoma therapy or death due to any cause, whichever occurs earlier.	Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part (DLBCL, FL and MCL): Up to 1.5 years
All Parts: Overall survival (OS)	OS is defined as the time from Day 1 of Cycle 1 to death.	Dose-Escalation: Up to 1 year; Expansion and Dose-OPT Part DLBCL, FL and MCL: Up to 1.5 years

Collaborators and Investigators

• Sponsor: Genmab
• Collaborators: AbbVie
• Investigators: Study Director: Study Official, Genmab

Publications and helpful links

General Publications

• Hutchings M, Mous R, Clausen MR, Johnson P, Linton KM, Chamuleau MED, Lewis DJ, Sureda Balari A, Cunningham D, Oliveri RS, Elliott B, DeMarco D, Azaryan A, Chiu C, Li T, Chen KM, Ahmadi T, Lugtenburg PJ. Dose escalation of subcutaneous epcoritamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2 study. Lancet. 2021 Sep 25;398(10306):1157-1169. doi: 10.1016/S0140-6736(21)00889-8. Epub 2021 Sep 8.
• Thieblemont C, Phillips T, Ghesquieres H, Cheah CY, Clausen MR, Cunningham D, Do YR, Feldman T, Gasiorowski R, Jurczak W, Kim TM, Lewis DJ, van der Poel M, Poon ML, Cota Stirner M, Kilavuz N, Chiu C, Chen M, Sacchi M, Elliott B, Ahmadi T, Hutchings M, Lugtenburg PJ. Epcoritamab, a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell-Engaging Antibody, in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in a Phase I/II Trial. J Clin Oncol. 2023 Apr 20;41(12):2238-2247. doi: 10.1200/JCO.22.01725. Epub 2022 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2018
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 10, 2018

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Disease Attributes; Hematologic Diseases; Leukemia, Lymphoid; Leukemia; Leukemia, B-Cell; Chronic Disease; Lymphoma; Lymphoma, B-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell
• Other Study ID Numbers: GCT3013-01; 2017-001748-36 (EudraCT Number); NL64317.078.17 (Registry Identifier: CCMO); 241053 (Other Identifier: IRAS ID; UK Research Summaries Database); 2023-504802-12-00 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No