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) (Breakfree-AiCE)

2025-524993-41-00 · tracked via the Priya Life Science EU tracker

Sponsor

Celgene Corp.

Sponsor type

Pharmaceutical company

Therapeutic area

Immune System Diseases

Decision date

10/08/2026

Enrollment target

Sites

Germany, Denmark

Condition studied

Chronic Immune Thrombocytopenia (cITP) and Autoimmune Hemolytic Anemia (AIHA)

Investigational medicinal product(s)

CD19-Targeted NEX-T CAR T

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Safety, including side effects after getting zola-cel and any unusual results in blood test., Blood Problem Improvement after getting zola-cel.

Endpoint detail

Other types of improvement, how long improvement lasts, need for extra help, other disease-specific health checks, and quality of life., Side effects are watched for the whole time after treatment.

Official registry record

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

View 2025-524993-41-00 on CTIS ↗ ← All trials in the EU