A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

NCT05869955 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: CA061-10012023-503823-24
• Study Type: interventional
• Target: 270
• Locations: 6 countries
• Sites: 46

Brief Summary

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Conditions

Idiopathic Inflammatory Myopathy; Systemic Sclerosis; Rheumatoid Arthritis; Systemic Lupus Erythematosus

Keywords

CC-97540; BMS-986353

Outcome Measures

Primary Outcomes (6)

• Number of participants with treatment-emergent adverse events (AEs) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with serious AEs (SAEs) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with AEs of special interest (AESI) in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with laboratory abnormalities in each indication.

  Up to 2 years after CC-97540 infusion

• Number of participants with Dose Limiting Toxicities (DLT) in each indication.

  Up to 2 years after CC-97540 infusion

• Recommended Phase 2 Dose (RP2D) of CC-97540 in each indication.

  Up to 2 years after CC-97540 infusion

Secondary Outcomes (16)

• Proportion of participants achieving definition of remission in SLE (DORIS) remission

  At week 24

• Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

  At week 24

• Change in proteinuria measured by urine protein creatinine ratio (UPCR)

  At week 24

• Change in Health Assessment Questionnaire - Disability Index (HAQ-DI)

  At week 24

• Proportion of participants achieving Myositis Response Criteria (MRC) Total Improvement Score (TIS) Major Response

  At Week 24

Study Arms (1)

Administration of CC-97540

EXPERIMENTAL

Drug: CC-97540; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

Interventions

Fludarabine DRUG

Specified dose on specified days

Administration of CC-97540

Cyclophosphamide DRUG

Specified dose on specified days

Administration of CC-97540

Tocilizumab DRUG

Specified dose on specified days

Administration of CC-97540

CC-97540 DRUG

Specified dose on specified days

Also known as: BMS-986353

Administration of CC-97540

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosis of Systemic Lupus Erythematosus (SLE) defined as follows:.
• i) Fulfilling the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria of SLE.
• ii) Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies at screening.
• \- SLE disease activity:.
• i) Active disease at screening, with recent ≥ 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.
• Diagnosis of Idiopathic Inflammatory Myopathy (IIM) defined as follows:.
• i) Fulfilling the 2017 EULAR/ACR classification criteria for probable or definite IIM.
• ii) Participant diagnosed with the following IIM subgroups: dermatomyositis (DM), immune-mediated necrotizing myopathy (IMNM), anti-synthetase syndrome (ASyS), and polymyositis (PM).
• iii) Presence of at least 1 myositis specific antibody (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
• IIM disease activity:.
• i) Severe/moderate 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.

You may not qualify if:

• \- 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.
• Present or recent clinically significant CNS pathology, within 12 months.
• IIM disease activity:.
• 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.
• \- RA disease activity:.
• i) Prior history of or current inflammatory joint disease other than RA.
• ii) Joint damage and/or deformity that may confound the investigator's ability to accurately assess disease activity.

Sponsors & Collaborators

• Bristol-Myers Squibb Services Unlimited Company: collaborator
• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (46)

Local Institution - 0035

Aurora, Colorado, 80045, United States

Location

Local Institution - 0024

Denver, Colorado, 80218, United States

Location

Local Institution - 0006

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0056

Miami, Florida, 33136, United States

Location

Local Institution - 0053

Chicago, Illinois, 60612, United States

Location

Local Institution - 0038

Boston, Massachusetts, 02115, United States

Location

Local Institution - 0033

Worcester, Massachusetts, 01655, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

Local Institution - 0031

Ann Arbor, Michigan, 48109-2800, United States

Location

Local Institution - 0037

Detroit, Michigan, 48202, United States

Location

Local Institution - 0022

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0010

St Louis, Missouri, 63110, United States

Location

Local Institution - 0028

Omaha, Nebraska, 68198, United States

Location

Local Institution - 0008

Summit, New Jersey, 07901, United States

Location

Local Institution - 0002

New York, New York, 10016, United States

Location

Local Institution - 0011

New York, New York, 10029, United States

Location

Local Institution - 0007

New York, New York, 10032, United States

Location

Local Institution - 0003

Chapel Hill, North Carolina, 27599, United States

Location

Local Institution - 0005

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0036

Dallas, Texas, 75390, United States

Location

Local Institution - 0029

Houston, Texas, 77030, United States

Location

Local Institution - 0034

Houston, Texas, 77030, United States

Location

Local Institution - 0004

Seattle, Washington, 98104, United States

Location

Local Institution - 0057

Seattle, Washington, 98105, United States

Location

Local Institution - 0058

Seattle, Washington, 98109, United States

Location

Local Institution - 0019

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Local Institution - 0044

Pessac, Aquitaine, 33600, France

Location

Local Institution - 0015

Montpellier, Hérault, 34295, France

Location

Local Institution - 0016

Lille, 59037, France

Location

Local Institution - 0040

Nice, 06202, France

Location

Local Institution - 0018

Paris, 75010, France

Location

Local Institution - 0020

Rennes, 35033, France

Location

Local Institution - 0049

Würzburg, Bavaria, 97080, Germany

Location

Local Institution - 0042

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Local Institution - 0041

Leipzig, Saxony, 04103, Germany

Location

Local Institution - 0045

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Local Institution - 0025

Berlin, 10117, Germany

Location

Local Institution - 0047

Düsseldorf, 40225, Germany

Location

Local Institution - 0017

Erlangen, 91054, Germany

Location

Local Institution - 0012

Rome, Lazio, 00168, Italy

Location

Local Institution - 0023

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0014

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Local Institution - 0013

Santander, Cantabria, 39008, Spain

Location

Local Institution - 0021

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Local Institution - 0050

Córdoba, 14004, Spain

Location

Local Institution - 0039

Málaga, 29011, Spain

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Myositis; Scleroderma, Systemic; Arthritis, Rheumatoid

Interventions

fludarabine; Cyclophosphamide; tocilizumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 23, 2023
• Study Start: September 13, 2023
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

ES (5); FR (6); US (25); BE (1); IT (2); DE (7)