NCT07115745RecruitingPhase 1
A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company55 sites in 10 countries125 target enrollmentStarted: September 4, 2025Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 125
- Locations
- 55
- Primary Endpoint
- Number of participants with AEs of special interest (AESIs)
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Systemic lupus erythematosus (SLE) population:.
- •i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
- •ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.
- •iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.
- •iv) Participants must have active disease at screening.
- •- Inflammatory myopathy (IIM) population:.
- •i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- •ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
- •iv) Evidence of active disease.
- •- Systemic sclerosis (SSc) population:.
- •i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
- •ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.
- •- Rheumatoid arthritis (RA) population:.
- •i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy.
Exclusion Criteria
- •- All participants:.
- •i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening.
- •vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.
- •SLE population:.
- •i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
- •IIM population:.
- •i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
- •SSc population:.
- •i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.
- •ii) Rapidly deteriorating SSc, or history of severe kidney disease.
- •RA population:.
- •i) People who have additional autoimmune diseases along with RA.
- •Other protocol-defined inclusion/exclusion criteria apply.
Arms & Interventions
BMS-986515 Administration
Experimental
Intervention: BMS-986515 (Genetic)
BMS-986515 Administration
Experimental
Intervention: Tocilizumab (Drug)
BMS-986515 Administration
Experimental
Intervention: Cyclophosphamide (Drug)
BMS-986515 Administration
Experimental
Intervention: Fludarabine (Drug)
Outcomes
Primary Outcomes
Number of participants with AEs of special interest (AESIs)
Time Frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with laboratory abnormalities
Time Frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with serious AEs (SAEs)
Time Frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with DLTs that occur during the DLT evaluation period
Time Frame: 28 days post-BMS-986515 infusion
All participants
Secondary Outcomes
- Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515(Up to 2 years)
- Maximum observed concentration (Cmax)(Up to 2 years)
- Area under the concentration-time curve (AUC)(Up to 2 years)
- Time of maximum observed concentration (Tmax)(Up to 2 years)
- Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24(Up to 2 years)
- Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24(Up to Week 24)
- Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24(Up to Week 24)
- Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24(Up to Week 24)
- Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24(Up to Week 24)
- Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24(Up to Week 24)
- Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline(Up to Week 24)
- Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline(Up to Week 24)
- Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24(Up to Week 24)
- Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24(Up to Week 24)
- Number of participants with low disease activity at Week 24 from baseline(Up to Week 24)
Investigators
Study Sites (55)
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