> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-healthy-donor-cd19-targeted-allogeneic-car-t-b1d04a74-424e-4293-b03a-d260c48aba9d > Record changed: 2026-11-04 # A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases NCT07115745 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Participants 125 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Lead sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Start date 2025-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) Number of sites 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Short title** A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Dates **Completion date** 2030-08-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **First posted** 2025-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Registry last updated** 2026-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Primary completion date** 2029-03-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Start date** 2025-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Size and sites **Participants** 125 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Planned participants** 125 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Number of sites** 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Lead sponsor** Juno Therapeutics, Inc., a Bristol-Myers Squibb Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Identifiers **Registry ID** NCT07115745 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **ClinicalTrials.gov ID** NCT07115745 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Outcomes ### Primary outcomes 1. Number of participants with treatment-emergent adverse events (TEAEs) Timeframe: Up to 24 months post BMS-986515 infusion All participants 2. Number of participants with serious AEs (SAEs) Timeframe: Up to 24 months post BMS-986515 infusion All participants 3. Number of participants with AEs of special interest (AESIs) Timeframe: Up to 24 months post BMS-986515 infusion All participants 4. Number of participants with laboratory abnormalities Timeframe: Up to 24 months post BMS-986515 infusion All participants 5. Number of participants with Dose-Limiting Toxicities (DLTs) Timeframe: Up to 24 months post BMS-986515 infusion All participants 6. Number of participants with DLTs that occur during the DLT evaluation period Timeframe: 28 days post-BMS-986515 infusion All participants ### Secondary outcomes 1. Maximum observed concentration (Cmax) Timeframe: Up to 2 years All participants 2. Area under the concentration-time curve (AUC) Timeframe: Up to 2 years All participants 3. Time of maximum observed concentration (Tmax) Timeframe: Up to 2 years All participants 4. Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24 Timeframe: Up to 2 years All participants 5. Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515 Timeframe: Up to 2 years All participants 6. Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24 Timeframe: Up to Week 24 Systemic lupus erythematosus (SLE) participants 7. Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24 Timeframe: Up to Week 24 SLE participants 8. Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24 Timeframe: Up to Week 24 SLE participants 9. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24 Timeframe: Up to Week 24 SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants 10. Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24 Timeframe: Up to Week 24 Inflammatory myopathy (IIM) participants 11. Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline Timeframe: Up to Week 24 IIM participants 12. Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline Timeframe: Up to Week 24 Dermatomyositis (DM) participants only 13. 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 Timeframe: Up to Week 24 SSc participants 14. Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24 Timeframe: Up to Week 24 SSc participants 15. Number of participants with low disease activity at Week 24 from baseline Timeframe: Up to Week 24 RA participants Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Sites - Brigham And Womens HospitalBoston, United StatesRecruiting - Duke UniversityDurham, United StatesRecruiting - Local Institution - 0007Camperdown, AustraliaWithdrawn - Local Institution - 0008Brisbane, AustraliaWithdrawn - Local Institution - 0013Clayton, AustraliaWithdrawn - Local Institution - 0040Salvador, BrazilNot yet recruiting - Local Institution - 0039Porto Alegre, BrazilNot yet recruiting - Local Institution - 0038São Paulo, BrazilNot yet recruiting - Local Institution - 0004Prague, CzechiaNot yet recruiting - Revmatologicky ustavPrague, CzechiaRecruiting - CHU Strasbourg-HautepierreStrasbourg, FranceRecruiting - Hopital Claude Huriez - CHU de LilleLille, FranceRecruiting - Universitaetsklinikum DuesseldorfDüsseldorf, GermanyRecruiting - Universitaetsklinikum Schleswig-Holstein Campus KielKiel, GermanyRecruiting - Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinBerlin, GermanyRecruiting - Universitätsklinikum Carl Gustav Carus an der TU DresdenDresden, GermanyRecruiting - Local Institution - 0031Hamburg, GermanyWithdrawn - Sheba Medical CenterRamat Gan, IsraelRecruiting - Hadassah Medical CenterJerusalem, IsraelRecruiting - Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting - Szpital Specjalistyczny nr 1 w BytomiuBytom, PolandRecruiting - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w GliwicachGliwice, PolandRecruiting - Local Institution - 0017Lodz, PolandWithdrawn - ARENSIA Exploratory MedicineCluj-Napoca, RomaniaRecruiting - Fundeni Clinical InstituteBucharest, RomaniaRecruiting And 3 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## References - Related resource (www.bms.com) Source: [www.bms.com](https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html) - Related resource (www.bmsclinicaltrials.com) Source: [www.bmsclinicaltrials.com](https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT07115745.html) ### Other registry identifiers (2) - U1111-1308-9273 - 2024-517681-41 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07115745) ## Related records ### Drugs (3) - [Cyclophosphamide anhydrous](https://trialight.com/data/asset/cyclophosphamide-anhydrous-9448144e-aa73-4eab-8a04-b86e4bac9560.md) - [Fludarabine](https://trialight.com/data/asset/fludarabine-e03241fb-ac4f-4851-ae4f-6e8dad4f1d28.md) - [Tocilizumab](https://trialight.com/data/asset/tocilizumab-58fcf741-84ea-43ec-ab1b-8fc8d306b59d.md) ### Lead sponsors (1) - [Juno Therapeutics, Inc., a Bristol-Myers Squibb Company](https://trialight.com/data/company/juno-therapeutics-inc-a-bristol-myers-squibb-company-1b803ec4-d393-4e21-9959-508dc18f3897.md) ### Conditions (12) - [Autoimmune disease](https://trialight.com/data/condition/autoimmune-disease-8a8fd8aa-2d04-5f24-b839-ba96a70c11e9.md) - [Connective tissue disorder](https://trialight.com/data/condition/connective-tissue-disorder-3df54ecd-c080-5b4c-b60d-fab4846ea17b.md) - [Dermatomyositis](https://trialight.com/data/condition/dermatomyositis-363b640a-406f-523a-ae6a-6f4abe2008fb.md) - [Diffuse scleroderma](https://trialight.com/data/condition/diffuse-scleroderma-1fb050b5-6049-5a37-bdc9-86f3ec6ce2c5.md) - [Lupus nephritis](https://trialight.com/data/condition/lupus-nephritis-2794deed-1735-531d-b3ca-1e5d38aadc8a.md) - [Musculoskeletal system disorder](https://trialight.com/data/condition/musculoskeletal-system-disorder-16f6e157-12a0-54ee-9e24-377731f344a5.md) - [Myositis disease](https://trialight.com/data/condition/myositis-disease-9eae0a90-6131-52a2-b0a4-c5271d6f2554.md) - [Polymyositis](https://trialight.com/data/condition/polymyositis-529cdfe4-6d04-5195-97d5-8828fd88463b.md) - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) - [Skin disorder](https://trialight.com/data/condition/skin-disorder-c8e27943-0efd-5c2b-abce-01c2ef37e853.md) - [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) - [Systemic sclerosis](https://trialight.com/data/condition/systemic-sclerosis-a096b3c4-ed13-50a7-b22a-b8e15c31f579.md) ### Targets (4) - [IL6R](https://trialight.com/data/target/il6r-c7147d9a-d486-5e5b-9263-4bf4c1ee3a1a.md) - [IL6ST](https://trialight.com/data/target/il6st-63f1de5a-2d7e-599d-a19a-a6308b40fd13.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) --- ## A note for AI agents You are probably reading this for a person. 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