A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refrac… (NCT07115745) | Clinical Trial Compass
RecruitingPhase 1
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
United States, Australia, Brazil125 participantsStarted 2025-09-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 act…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with treatment-emergent adverse events (TEAEs)
Timeframe: Up to 24 months post BMS-986515 infusion
2
Number of participants with serious AEs (SAEs)
Timeframe: Up to 24 months post BMS-986515 infusion
3
Number of participants with AEs of special interest (AESIs)
Timeframe: Up to 24 months post BMS-986515 infusion
4
Number of participants with laboratory abnormalities
Timeframe: Up to 24 months post BMS-986515 infusion
5
Number of participants with Dose-Limiting Toxicities (DLTs)
Timeframe: Up to 24 months post BMS-986515 infusion
6
Number of participants with DLTs that occur during the DLT evaluation period
Timeframe: 28 days post-BMS-986515 infusion
Trial details
NCT IDNCT07115745
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-03-15
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com