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Clinical Trials in the UK / NCT07603557
Starting soon Phase 2

Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)

NCT07603557 · tracked via the Priya Life Science UK tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 2
Started
2026-08-31
Last updated
2026-07-09

Condition(s) studied

Chronic Immune ThrombocytopeniaAutoimmune Hemolytic Anemia

Investigational drug(s) / intervention(s)

BMS-986353Fludarabine PhosphateCyclophosphamide

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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)

Trial sites (8)

FacilityCityRegionStatus
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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07603557 on ClinicalTrials.gov ↗ ← All trials in the UK