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)

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524993-41-00

Enrollment

Registered

2026-08-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed description

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.

Interventions

DRUGCD19-Targeted NEX-T CAR T

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 11, 2026