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Not yet taking people in United KingdomPhase 2

Zola-cel CAR T cell therapy for chronic immune thrombocytopenia and autoimmune hemolytic anemia

Tests zola-cel in adults with chronic immune thrombocytopenia or autoimmune hemolytic anemia.

Key facts

Who runs it
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Where
London and Sheffield, United KingdomSee the 2 sitesAlso in 3 other countries, 6 sites
Trial code
Registry title
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
Status
Not yet recruiting
Phase
Phase 2
People taking part
52 people, planned
Started
31 Aug 2026
Expected to end
6 May 2030
Type of study
Interventional, 4 groups
Treatments tested
  • BMS-986353
  • Fludarabine Phosphate
  • Cyclophosphamide
Record updated
9 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic immune thrombocytopenia (cITP, low platelets) or autoimmune hemolytic anemia (AIHA, red blood cells destroyed by the immune system). Earlier treatments must have failed or stopped working. Everyone gets the CAR T cell therapy Zola-cel (BMS-986353).

Age
18 Years and older
Sex
All
Disease stage
Chronic ITP, or AIHA (warm AIHA, cold agglutinin disease or mixed AIHA). There must be no other signs of a body-wide autoimmune disease. People with AIHA must have documented hemolysis (red cell breakdown).
Earlier treatment
ITP: relapsed after or cannot tolerate corticosteroids, and failed, relapsed after or cannot tolerate therapies with ≥ 2 mechanisms of action, at least one immunosuppressive or immunomodulatory. AIHA: failed, relapsed after or cannot tolerate at least 2 prior lines of treatment with 2 mechanisms of action, one an anti-CD20 monoclonal antibody unless it cannot be used. For warm or mixed AIHA, corticosteroids and IVIG do not count.
Biomarker or test result
ITP: platelet count < 30 × 109/L, or < 50 × 109/L for people on a TPO-RA. AIHA: Hb <10 g/dL without red blood cell transfusion, or depending on transfusions.

Main reasons for not taking part

  • ITP or AIHA linked to Evans syndrome, another autoimmune disease needing immune-suppressing therapy, hepatitis C, HIV, drugs, surgery or blood cancers
  • COVID-19 vaccine-induced immune thrombotic thrombocytopenia
  • Solid organ cancer in the past, unless free of it for ≥ 2 years
  • Low neutrophils (ANC < 1.5 × 109/L) or needing G-CSF or GM-CSF support
  • Liver or clotting test results above the limits set by the protocol

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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
  • 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

Who cannot take part

  • 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 in United Kingdom

Also in 3 other countries, 6 sites

  • London, Greater LondonHospital not named in the registryContact: Site 401Not yet recruiting
  • SheffieldHospital not named in the registryContact: Site 402Not yet recruiting

About the trial

What the trial wants to find out

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).

The 4 groups in the trial

  • Cohort 1 Part A ITPTreatment being tested

    Treatment: BMS-986353, Fludarabine Phosphate, and Cyclophosphamide

  • Cohort 1 Part A AIHATreatment being tested

    Treatment: BMS-986353, Fludarabine Phosphate, and Cyclophosphamide

  • Cohort 1 Part BTreatment being tested

    Treatment: BMS-986353, Fludarabine Phosphate, and Cyclophosphamide

  • Cohort 2Treatment being tested

    Treatment: BMS-986353, Fludarabine Phosphate, and Cyclophosphamide

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 2, Multicenter, Open-Label Study of Zolacabtagene Autoleucel (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)
Plain-language title
Zola-cel CAR T cell therapy for chronic immune thrombocytopenia and autoimmune hemolytic anemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
9 July 2026