Starting soon
Phase 2
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
Condition(s) studied
Chronic Immune ThrombocytopeniaAutoimmune Hemolytic Anemia
Investigational drug(s) / intervention(s)
BMS-986353: Specified dose of specified days
Fludarabine Phosphate: Specified dose of specified days
Cyclophosphamide: Specified dose on specified days
Study summary
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).
Eligibility
Inclusion Criteria
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
Exclusion Criteria
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.
Primary outcome measure(s)
- Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs) — Up to approximately Month 36
- Cohort 1 Part A: Number of participants with serious AEs (SAEs) — Up to approximately Month 36
- Cohort 1 Part A: Number of participants with AEs of special interest (AESI) — Up to approximately Month 36
- Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities — Up to approximately Month 36
- Cohort 1 Part B: Hematologic Complete Response (CR) — Up to approximately Month 6
Trial sites (8)
| Facility | City | Region | Status |
| Local Institution - 101 |
Boston |
Massachusetts |
|
| Local Institution - 103 |
Houston |
Texas |
|
| Local Institution - 102 |
Seattle |
Washington |
|
| Local Institution - 201 |
Odense |
Denmark |
|
| Local Institution - 301 |
Magdeburg |
Saxony-Anhalt |
|
| Local Institution - 302 |
Erlangen |
Germany |
|
| Local Institution - 401 |
London |
Greater London |
|
| Local Institution - 402 |
Sheffield |
United Kingdom |
|
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