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Zola-cel CAR T cells for chronic immune thrombocytopenia and autoimmune hemolytic anemia

Tests zola-cel in adults with chronic immune thrombocytopenia or autoimmune hemolytic anemia.

Key facts

Who runs it
Celgene Corp.
Where
Erlangen and Magdeburg, GermanySee the 2 sitesAlso in 1 other country, 1 site
Trial code
Registry title
Study of Zola-cel (BMS-986353), CD19 NEX-T CAR T Cells in Autoimmune Cytopenia (Breakfree-AiCE)
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

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic immune thrombocytopenia (cITP, low platelets) or autoimmune hemolytic anemia (AIHA, the immune system destroys red blood cells). It tests zola-cel, a CAR T cell treatment.

Age
18 years or older.
Sex
All sexes can join.
Disease stage
For cITP: platelet count below 30 × 109/L, or below 50 × 109/L if taking TPO-RA medicines. For AIHA: red blood cell breakdown (hemolysis) confirmed by the doctor, and hemoglobin below 10 g/dL without transfusion, or needing transfusions.
Earlier treatment
At least 2 earlier treatments that did not work or had to be stopped because of side effects.

Main reasons for not taking part

  • ITP or AIHA linked to Evans syndrome
  • Other autoimmune disease needing immunosuppressant medicines
  • Disease caused by viruses such as hepatitis C or HIV, or by certain drugs, vaccines or surgery
  • Blood cancer
  • Other cancer within 2 years

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 Germany

Also in 1 other country, 1 site

  • Universitaetsklinikum Erlangen AöRErlangen, GermanyNot yet recruiting
  • Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyNot 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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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)
Plain-language title
Zola-cel CAR T cells for chronic immune thrombocytopenia and autoimmune hemolytic anemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
13 August 2026