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Treatment for severe autoimmune diseases using CAR T cells

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)

PHASE1 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT05869955

This study is testing a new CAR T cell therapy to see if it can help people with severe autoimmune diseases like lupus and scleroderma feel better.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment270 (estimated)
Ages18 Years and up
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company (industry)
Drugs / interventionsbelimumab, anifrolumab, rituximab, obinutuzumab, tocilizumab, nintedinib, methotrexate, cyclophosphamide
Locations54 sites (Aurora, Colorado and 53 other locations)
Trial IDNCT05869955 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and preliminary effectiveness of CC-97540, a CAR T cell therapy targeting CD-19, in patients suffering from severe, refractory autoimmune diseases such as Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, and Systemic Sclerosis. Participants will receive a combination of CC-97540 along with Fludarabine, Cyclophosphamide, and Tocilizumab. The study aims to assess tolerability, pharmacokinetics, and initial efficacy outcomes in this patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with severe, refractory autoimmune diseases who have not responded adequately to multiple prior therapies.

Not a fit: Patients with mild autoimmune diseases or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with severe autoimmune diseases that have not responded to existing treatments.

How similar studies have performed: Other studies using CAR T cell therapies for autoimmune conditions have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

* 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.

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

D. Participants diagnosed IIM AND progressive Interstitial Lung Disease (ILD) on high-resolution computed tomography (HRCT)

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, IVIG, JAK inhibitors, and rituximab.

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

  i) Fulfilling 2013 EULAR/ACR classification criteria for SSc.

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

\- SSc disease activity:.

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

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

\- Rheumatoid Arthritis (RA) disease activity:.

i) Minimum of 3 SJC and 3 TJC on a 66/68 joint count (SJC/TJC).

ii) OR participants diagnosed with progressive ILD (interstitial lung disease).

iii) AND Inadequate disease response or intolerance to at least one conventional synthetic disease-modifying antirheumatic drug (DMARD) and as well as ≥ 2 DMARDs with different mechanisms of action from the categories biologic disease-modifying antirheumatic drug (bDMARDs) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) for a minimum of 3 months.

A. Participants qualifying on progressive ILD may have exhausted the therapies above OR have demonstrated inadequate disease response or intolerance to at least one of the following treatments used for at least 3 months: mycophenolate, tocilizumab, cyclophosphamide, rituximab, azathioprine, nintedinib, pirfenidone.

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.

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.

\- Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Aurora, Colorado and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis, CC-97540, BMS-986353

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.