Trials / Recruiting
RecruitingNCT07115745
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 125 (estimated)
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | BMS-986515 | Specified dose on specified days |
| DRUG | Fludarabine | Specified dose on specified days |
| DRUG | Cyclophosphamide | Specified dose on specified days |
| DRUG | Tocilizumab | Specified dose on specified days |
Timeline
- Start date
- 2025-09-04
- Primary completion
- 2029-03-15
- Completion
- 2030-08-16
- First posted
- 2025-08-11
- Last updated
- 2026-03-04
Locations
28 sites across 10 countries: United States, Australia, Brazil, Czechia, France, Germany, Israel, Poland, Romania, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07115745. Inclusion in this directory is not an endorsement.