Not yet taking people in DenmarkPhase 2
Study of Zola-cel (BMS-986353), CD19 NEX-T CAR T Cells in Autoimmune Cytopenia (Breakfree-AiCE)
Key facts
- Who runs it
- Celgene Corp.
- Where
- Odense C, DenmarkSee the siteAlso in 1 other country, 2 sites
- Trial code
- EU 2025-524993-41-00
- U1111-1332-7636
- Status
- Not yet recruiting
- Phase
- Phase 2
- People taking part
- 3 people, planned
- Started
- 3 Aug 2026
- Expected to end
- 6 May 2030
- Type of study
- Interventional
- Record updated
- 13 August 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- Participants with cITP or AIHA
- At least 18 years of age
- Participants who have received at least 2 previous therapies which either did not work for the person or the person could not continue taking them due to side effects
- For cITP, the platelet counts need to be < 30 × 109/L or < 50 × 109/L if on certain medications called TPO-RA
- For AIHA, hemolysis needs to be documented by participant's doctor and the hemoglobin needs to be <10 g/dL without red blood cell transfusion, or transfusion dependent
Who cannot take part
- ITP or AIHA associated with Evans syndrome, other autoimmune disease affecting whole body or a single organ requiring specific medications called immunosuppressants, certain viral-induced conditions including hepatitis C virus and HIV, certain drug and vaccine induced conditions, surgical procedures, hematologic malignancies (blood cancer), or nonblood cancer within 2 years
Where in Denmark
Also in 1 other country, 2 sites
- Region SyddanmarkOdense C, DenmarkNot yet recruiting
About the trial
What the trial wants to find out
To evaluate the safety and tolerability of zola-cel in participants with ITP and participants with AIHA (Cohort 1 Part A). To evaluate the efficacy of zola-cel in participants with ITP and participants with AIHA (Cohort 1 Part B).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- 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) (Breakfree-AiCE)
- Record updated
- 13 August 2026