Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Study ID
- NCT07603557
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Autoimmune Hemolytic Anemia
- Chronic Immune Thrombocytopenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986353 — BIOLOGICALSpecified dose of specified days
- Fludarabine Phosphate — DRUGSpecified dose of specified days
- Cyclophosphamide — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
Key Dates
- Start date
- Jun 15, 2026
- Status verified
- Apr 2026
- Primary completion
- May 6, 2030
- Completion
- May 6, 2030
Study Design
- Enrollment
- 52 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1 Part A ITP
- Experimental: Cohort 1 Part A AIHA
- Experimental: Cohort 1 Part B
- Experimental: Cohort 2
Primary Outcome Measure
Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to approximately Month 36 ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 101 | Boston | Massachusetts | 02114 | Site 101 |
| Local Institution - 103 | Houston | Texas | 77030-2740 | Site 103 |
| Local Institution - 102 | Seattle | Washington | 98109 | Site 102 |