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, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company105 sites in 6 countries270 target enrollmentSeptember 13, 2023

InterventionsCC-97540 Fludarabine Cyclophosphamide Tocilizumab

DrugsCC-97540 Fludarabine Cyclophosphamide Tocilizumab

Overview

Phase: Phase 1
Intervention: CC-97540
Conditions: Not specified
Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Enrollment: 270
Locations: 105
Primary Endpoint: Number of participants with treatment-emergent adverse events (AEs) in each indication.
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 13, 2023

End Date

August 29, 2028

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\- 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.

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.
•Present or recent clinically significant CNS pathology, within 12 months.
•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.

Arms & Interventions

Administration of CC-97540

Intervention: CC-97540

Administration of CC-97540

Intervention: Fludarabine

Administration of CC-97540

Intervention: Cyclophosphamide

Administration of CC-97540

Intervention: Tocilizumab