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

NCT07603557 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CA061-1040
• Study Type: interventional
• Target: 52
• Locations: 4 countries
• Sites: 8

Brief 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).

Conditions

Autoimmune Hemolytic Anemia; Chronic Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (5)

• 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

Secondary Outcomes (27)

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

  Up to approximately Month 6

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

  Up to approximately Month 6

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

  Up to approximately Month 36

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

  Up to approximately Month 36

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

  Up to approximately Month 36

Study Arms (4)

Cohort 1 Part A ITP

EXPERIMENTAL

Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide

Cohort 1 Part A AIHA

EXPERIMENTAL

Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide

Cohort 1 Part B

EXPERIMENTAL

Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide

Cohort 2

EXPERIMENTAL

Biological: BMS-986353; Drug: Fludarabine Phosphate; Drug: Cyclophosphamide

Interventions

BMS-986353 BIOLOGICAL

Specified dose of specified days

Also known as: Zolacabtagene autoleucel, Zola-cel, CC-97540

Cohort 1 Part A AIHA; Cohort 1 Part A ITP; Cohort 1 Part B; Cohort 2

Fludarabine Phosphate DRUG

Specified dose of specified days

Cohort 1 Part A AIHA; Cohort 1 Part A ITP; Cohort 1 Part B; Cohort 2

Cyclophosphamide DRUG

Specified dose on specified days

Cohort 1 Part A AIHA; Cohort 1 Part A ITP; Cohort 1 Part B; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (8)

Local Institution - 101

Boston, Massachusetts, 02114, United States

Location

Local Institution - 103

Houston, Texas, 77030-2740, United States

Location

Local Institution - 102

Seattle, Washington, 98109, United States

Location

Local Institution - 201

Odense, DK-5000, Denmark

Location

Local Institution - 301

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

Local Institution - 302

Erlangen, 91054, Germany

Location

Local Institution - 401

London, Greater London, W12 OHS, United Kingdom

Location

Local Institution - 402

Sheffield, S10 2SJ, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

fludarabine phosphate; Cyclophosphamide

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): May 6, 2030
• Study Completion (Estimated): May 6, 2030
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

DE (2); US (3); DK (1); GB (2)