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

NCT07603557 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-05-22

No results posted yet for this 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).

Conditions

  • Chronic Immune Thrombocytopenia
  • Autoimmune Hemolytic Anemia

Interventions

BIOLOGICAL

BMS-986353

Specified dose of specified days

DRUG

Fludarabine Phosphate

Specified dose of specified days

DRUG

Cyclophosphamide

Specified dose on specified days

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2030-05-06
Completion
2030-05-06
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07603557 on ClinicalTrials.gov