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Chronic Immune ThrombocytopeniaPhase 2NCT07603557

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

A Phase 2 study testing BMS-986353, Fludarabine Phosphate and Cyclophosphamide in people with Chronic Immune Thrombocytopenia and Autoimmune Hemolytic Anemia, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 8 sites in 4 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BMS-986353, Fludarabine Phosphate and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
8 sitesin 4 countries
Study dates
31 Aug 2026to 6 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.

Trial locations and contacts

8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

8 sites in 4 countries

United States3 sites

  • 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

Other trials in United States

Germany2 sites

  • Local Institution - 302

    Erlangen, 91054

    Site 302

  • Local Institution - 301

    Magdeburg, Saxony-Anhalt, 39120

    Site 301

Other trials in Germany

United Kingdom2 sites

  • Local Institution - 401

    London, Greater London, W12 OHS

    Site 401

  • Local Institution - 402

    Sheffield, S10 2SJ

    Site 402

Other trials in United Kingdom

Denmark1 site

  • Local Institution - 201

    Odense, DK-5000

    Site 201

Other trials in Denmark

About this study

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)

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).

Being tested
BMS-986353, Fludarabine Phosphate, Cyclophosphamide
Medical subject headings
Anemia, Hemolytic, Autoimmune

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-986353Biological

    Also called Zolacabtagene autoleucel, Zola-cel, CC-97540

    Specified dose of specified days

  • Fludarabine PhosphateDrug

    Specified dose of specified days

  • CyclophosphamideDrug

    Specified dose on specified days

Study groups in NCT07603557
Study groupRoleWhat they receive
Cohort 1 Part A ITPExperimentalNot described
Receives: Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide
Cohort 1 Part A AIHAExperimentalNot described
Receives: Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide
Cohort 1 Part BExperimentalNot described
Receives: Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide
Cohort 2ExperimentalNot described
Receives: Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs)

    Measured: Up to approximately Month 36

  2. Cohort 1 Part A: Number of participants with serious AEs (SAEs)

    Measured: Up to approximately Month 36

  3. Cohort 1 Part A: Number of participants with AEs of special interest (AESI)

    Measured: Up to approximately Month 36

  4. Cohort 1 Part A: Number of participants with clinically significant laboratory abnormalities

    Measured: Up to approximately Month 36

  5. Cohort 1 Part B: Hematologic Complete Response (CR)

    Measured: Up to approximately Month 6

Secondary outcomes (27)

  1. Cohort 1 PART B: Hematologic Overall Response (OR)

    Measured: Up to approximately Month 6

  2. Cohort 1 PART A and Cohort 2: Hematologic CR and OR

    Measured: Up to approximately Month 6

  3. Cohort 1 PART B and Cohort 2: Number of participants with TEAEs

    Measured: Up to approximately Month 36

  4. Cohort 1 PART B and Cohort 2: Number of participants with SAEs

    Measured: Up to approximately Month 36

  5. Cohort 1 PART B and Cohort 2: Number of participants with AESIs

    Measured: Up to approximately Month 36

  6. Cohort 1 PART B and Cohort 2: Number of participants with clinically significant laboratory abnormalities

    Measured: Up to approximately Month 36

  7. Number of participants with Hematologic PR

    Measured: Up to approximately Month 6

  8. Number of participants with Hematologic CR

    Measured: Up to approximately Month 36

  9. Number of participants with Hematologic PR

    Measured: Up to approximately Month 36

  10. Number of participants with Hematologic OR

    Measured: Up to approximately Month 36

  11. Number of participants with Best Overall Response (BOR)

    Measured: Up to approximately Month 36

  12. Number of participants with durable CR, PR and OR

    Measured: Up to approximately 12 months from Zola-cel infusion

  13. Time to First Response (TTR)

    Measured: Up to approximately Month 36

  14. Time to First Complete Response (TTCR)

    Measured: Up to approximately Month 36

  15. Duration of response (DOR)

    Measured: Up to approximately Month 36

  16. Treatment-free Remission (TFR)

    Measured: Up to approximately Month 36

  17. Proportion of participants who requires rescue therapy for ITP or AIHA

    Measured: Up to approximately Month 36

  18. Time to first administration of rescue therapy for ITP or AIHA

    Measured: Up to approximately Month 36

  19. Proportion of AIHA participants who experience hemolysis features

    Measured: Up to approximately Month 36

  20. Number of AIHA participants with cold agglutinin disease (CAD) who experience acrocyanosis

    Measured: Up to approximately Month 36

  21. Change from baseline in hemolysis indicators in AIHA participants

    Measured: Up to approximately Month 36

  22. Proportion of ITP participants with WHO-classified bleeding events as assessed by WHO bleeding scale

    Measured: Up to approximately Month 36

  23. Change from baseline in 36-Item Short Form Health Questionnaire version 2 (SF-36 v2)

    Measured: Up to approximately Month 36

  24. Change from baseline in Patient Global Impression of Severity (PGI-S) Fatigue score

    Measured: Up to approximately Month 36

  25. Patient Global Impression of Change (PGI-C) Fatigue mean score

    Measured: Up to approximately Month 36

  26. Change from baseline in Immune Thrombocytopenia-Patient Assessment Questionnaire (ITP - PAQ) score

    Measured: Up to approximately Month 36

  27. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score

    Measured: Up to approximately Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2026
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion6 May 2030 (estimated)
  4. Study completion6 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07603557
Sponsor's protocol ID
CA061-1040
Status last verified
Jul 2026
First submitted
18 May 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMS-986353, Fludarabine Phosphate and Cyclophosphamide in people with Chronic Immune Thrombocytopenia and Autoimmune Hemolytic Anemia, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 8 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Germany, United Kingdom, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1 Part A: Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to approximately Month 36). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07603557.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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