Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
Starting soon · Phase 2
Conditions studied: Chronic Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
In brief
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 facts
- Study ID
- NCT07603557
- Run by
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- People needed
- 52
- Starts
- 2026-08-31
- Expected to finish
- 2030-05-06
- Last updated by the study team
- 2026-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Inclusion Criteria for ITP
- Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.
- Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.
- Platelet count < 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count < 50 × 109/L.
- Inclusion Criteria for AIHA
- Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.
- o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.
- o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.
- Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
- Documented hemolysis
You may not qualify if…
- Medical Conditions
- ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.
- COVID-19 Vaccine-induced immune thrombotic thrombocytopenia
- Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.
- Laboratory Test Findings
- Peripheral blood ANC < 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: > 3 × ULN AIHA: ALT > 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin > 1.5 × ULN AIHA: direct bilirubin > 1.5 × ULN o International normalized ratio (INR) > 1.5 × ULN
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- Local Institution - 101 — Boston, Massachusetts, United States
- Local Institution - 103 — Houston, Texas, United States
- Local Institution - 102 — Seattle, Washington, United States
- Local Institution - 201 — Odense, Denmark
- Local Institution - 301 — Magdeburg, Saxony-Anhalt, Germany
- Local Institution - 302 — Erlangen, Germany
- Local Institution - 401 — London, Greater London, United Kingdom
- Local Institution - 402 — Sheffield, United Kingdom
Full record on ClinicalTrials.gov
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