A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases

March 29, 2024 updated by: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy or Systemic Sclerosis

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

129

Phase

  • 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: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

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

Study Locations

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Not yet recruiting
        • Local Institution - 0019
        • Contact:
          • Site 0019
  • France
      • Lille, France, 59037
        • Not yet recruiting
        • Hopital Claude Huriez - CHU de Lille
        • Contact:
          • Ibrahim YAKOUB-AGHA, Site 0016
          • Phone Number: +33320445551
      • Nice, France, 06202
        • Not yet recruiting
        • Local Institution - 0040
        • Contact:
          • Site 0040
      • Paris, France, 75010
        • Not yet recruiting
        • Hopital Saint-Louis
        • Contact:
          • Dominique Farge, Site 0018
          • Phone Number: 33 1 42 49 97 64
      • Rennes, France, 35033
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
        • Contact:
          • Roch Houot, Site 0020
          • Phone Number: 33299289873
    • Alsace
      • Strasbourg, Alsace, France, 67098
        • Not yet recruiting
        • Local Institution - 0043
        • Contact:
          • Site 0043
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Not yet recruiting
        • Local Institution - 0044
        • Contact:
          • Site 0044
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Not yet recruiting
        • CHU Montpellier Lapeyronie Hospital
        • Contact:
          • Jacques Morel, Site 0015
          • Phone Number: 33467338710
  • Germany
      • Berlin, Germany, 10117
        • Not yet recruiting
        • Local Institution - 0025
        • Contact:
          • Site 0025
      • Erlangen, Germany, 91054
        • Not yet recruiting
        • Local Institution - 0017
        • Contact:
          • Site 0017
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Not yet recruiting
        • Local Institution - 0049
        • Contact:
          • Site 0049
    • Nordrhein-Westfalen
      • Köln, Nordrhein-Westfalen, Germany, 50937
        • Not yet recruiting
        • Local Institution - 0042
        • Contact:
          • Site 0042
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Not yet recruiting
        • Local Institution - 0041
        • Contact:
          • Site 0041
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39120
        • Not yet recruiting
        • Local Institution - 0045
        • Contact:
          • Site 0045
  • Italy
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Not yet recruiting
        • Local Institution - 0012
        • Contact:
          • Site 0012
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Not yet recruiting
        • Local Institution - 0023
        • Contact:
          • Site 0023
  • Spain
      • Cordoba, Spain, 14004
        • Not yet recruiting
        • Local Institution - 0050
        • Contact:
          • Site 0050
      • Málaga, Spain, 29011
        • Not yet recruiting
        • Local Institution - 0039
        • Contact:
          • Site 0039
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Not yet recruiting
        • Local Institution - 0013
        • Contact:
          • Site 0013
    • Catalunya [Cataluña]
      • Barcelona, Catalunya [Cataluña], Spain, 08036
        • Not yet recruiting
        • Local Institution - 0021
        • Contact:
          • Site 0021
  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Local Institution - 0035
        • Contact:
          • Site 0035
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Richard Nash, Site 0024
          • Phone Number: 720-754-4800
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Not yet recruiting
        • Local Institution - 0048
        • Contact:
          • Site 0048
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
          • Vikas Majithia, Site 0006
          • Phone Number: 904-953-2000
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Local Institution - 0030
        • Contact:
          • Site 0030
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Local Institution - 0038
        • Contact:
          • Site 0038
      • Boston, Massachusetts, United States, 02115
        • Not yet recruiting
        • Local Institution - 0046
        • Contact:
          • Site 0046
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • University of Massachusetts Chan Medical School
        • Contact:
          • Jonathan Gerber, Site 0032
          • Phone Number: 508-635-7093
      • Worcester, Massachusetts, United States, 01655
        • Not yet recruiting
        • Local Institution - 0033
        • Contact:
          • Site 0033
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-2800
        • Not yet recruiting
        • Local Institution - 0031
        • Contact:
          • Site 0031
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Local Institution - 0037
        • Contact:
          • Site 0037
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester, Minnesota
        • Contact:
          • Uma Thanarajasingam, Site 0022
          • Phone Number: 507-254-2261
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Not yet recruiting
        • Washington University School of Medicine
        • Contact:
          • Alfred Kim, Site 0010
          • Phone Number: 314-326-4785
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Not yet recruiting
        • Local Institution - 0028
        • Contact:
          • Site 0028
    • New Jersey
      • Summit, New Jersey, United States, 07901
        • Recruiting
        • Atlantic Health System Overlook Medical Center
        • Contact:
          • Neil Kramer, Site 0008
          • Phone Number: 646-734-2774
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Amit Saxena, Site 0002
          • Phone Number: 516-205-7051
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
          • Anca Askanase, Site 0007
          • Phone Number: 555-555-5555
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
        • Contact:
          • Margrit Wiesendanger, Site 0011
          • Phone Number: 646-285-7881
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • The University of North Carolina at Chapel Hill
        • Contact:
          • Saira Sheikh, Site 0003
          • Phone Number: 919-966-0545
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
          • Emily Littlejohn, Site 0005
          • Phone Number: 216-445-5559
    • Texas
      • Dallas, Texas, United States, 75390-88520
        • Not yet recruiting
        • Local Institution - 0036
        • Contact:
          • Site 0036
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0034
        • Contact:
          • Site 0034
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Local Institution - 0029
        • Contact:
          • Site 0029
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Contact:
          • Philip Mease, Site 0004
          • Phone Number: 206-386-2000

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.

i) Fulfilling the 2019 ACR/EULAR classification criteria of SLE.

ii) Presence of anti-dsDNA, anti-histone, anti-chromatin, or anti-Sm antibodies.

- SLE disease activity.

i) Active disease at screening, defined as ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system).

ii) Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus or voclosporin.

A. Insufficient response is defined as lack of response, insufficient response or lack of sustained response to appropriate doses. Intolerance is not considered insufficient response.

B. Methotrexate and azathioprine use will count as 1 for the purposes of the number of failed treatments.

- Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.

i) Fulfilling the 2017 ACR/EULAR classification criteria for probable or definite IIM.

ii) Participant diagnosed with the following IIM subgroups: DM, immune-mediated necrotizing myopathy (IMNM), and anti-synthetase syndrome (ASyS).

iii) Presence of at least 1 myositis specific (MSA), associated antibody (MAA), or ANA at screening or prior to screening.

- IIM disease activity.

i) Severe muscle AND/OR skin involvement.

ii) Proof of activity as documented by:.

A. An active myositis-associated rash OR.

B. A recent muscle biopsy OR.

C. An elevated CK > 3 times the upper limit of normal.

iii) Inadequate response to glucocorticoids and at least 2 of the following treatments used for at least 3 months: azathioprine, methotrexate, cyclosporin A, tacrolimus, MMF, cyclophosphamide, leflunomide, IVIG, and rituximab.

- Diagnosis of Systemic Sclerosis (SSc) defined as follows:.

i) Fulfilling 2013 ACR and European League Against Rheumatism classification criteria for SSc.

ii) Antinuclear Antibody (ANA) positive at screening or prior to screening.

- SSc disease activity.

i) Participants diagnosed with diffuse or limited cutaneous SSc AND progressive ILD.

ii) Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, or tocilizumab.

Exclusion Criteria

  • Diagnosis of drug-induced SLE rather than idiopathic SLE.
  • Other systemic autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded.
  • SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease, are excluded.
  • Recent or present clinically significant CNS pathology.

  • IIM disease activity.

    i) Other forms of IIM: Inclusion Body Myositis, Amyopathic DM, any form of juvenile myositis.

ii) Myositis other than IIM, eg, drug-induced myositis and PM associated with HIV.

iii) Participants with severe muscle damage (Physician VAS for muscle damage in Myositis Damage Index > 7 cm on a 10 cm scale), permanent weakness due to a non-IIM cause (eg, stroke), or myositis with cardiac involvement.

- SSc disease activity.

i) SSc related PAH requiring active treatment.

ii) Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.

iii) Prior scleroderma renal crisis.

- Other protocol-defined Inclusion/Exclusion criteria apply.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Administration of CC-97540
Drug: Cyclophosphamide
Specified dose on specified days
Drug: Fludarabine
Specified dose on specified days
Drug: CC-97540
Specified dose on specified days
Other Names:
  • BMS-986353

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-emergent adverse events (AEs) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with serious AEs (SAEs) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with AEs of special interest (AESI) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with laboratory abnormalities in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Number of participants with Dose Limiting Toxicities (DLT) in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion
Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.
Time Frame: Up to 2 years after CC-97540 infusion
Up to 2 years after CC-97540 infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame: At week 24
At week 24
Maximum observed blood concentration (Cmax)
Time Frame: Up to 2 years
Up to 2 years
Time of maximum observed blood concentration (Tmax)
Time Frame: Up to 2 years
Up to 2 years
Area under the blood concentration-time curve from time zero to 28 days after dosing (AUC(0-28D))
Time Frame: Up to 2 years
Up to 2 years
Proportion of participants achieving definition of remission in SLE (DORIS) remission
Time Frame: At week 24
SLE Cohort
At week 24
Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)
Time Frame: At week 24
SLE Cohort
At week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR)
Time Frame: At week 24
SLE Cohort
At week 24
Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response
Time Frame: At Week 24
IIM Cohort
At Week 24
Change in the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Time Frame: At Week 24
Only Dermatomyositis (DM) participants in the IIM Cohort
At Week 24
Proportion of participants with ILD with no worsening of pulmonary function including forced expiratory volume (FEV1) (> 10%), forced vital capacity (FVC) (> 10%), and diffusing capacity of the lung for carbon monoxide (DLCO) (> 15%)
Time Frame: At Week 24
IIM Cohort
At Week 24
Proportion of participants achieving a minimal clinically important difference (MCID) of 24% change from baseline of the modified Rodnan Skin Score (mRSS)
Time Frame: At Week 24
SSc Cohort
At Week 24
Participants with an improvement from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS)
Time Frame: At Week 24
SSc Cohort
At Week 24
The worsening of pulmonary function including FVC (>10% absolute), DLCO (>15% absolute decline) in participants with interstitial lung disease (ILD)
Time Frame: At Week 24
SSc Cohort
At Week 24

Collaborators and Investigators

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

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Collaborators

Bristol-Myers Squibb Services Unlimited Company

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.

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)

September 13, 2023

Primary Completion (Estimated)

November 15, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

May 11, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

May 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA061-1001
  • 2023-503823-24 (EudraCT Number)

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 Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.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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