ClinicalTrials.gov record NCT07603557
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
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)
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 2, open-label study evaluates Zola-cel (BMS-986353), a CD19-targeted NEX-T CAR T cell product, given with fludarabine and cyclophosphamide in adults with chronic immune thrombocytopenia (cITP) or autoimmune hemolytic anemia (AIHA) who have received prior treatments. The study is non-randomized and uses a single treatment group. It measures safety and hematologic responses with follow-up assessments up to about 36 months.
What it is studying. The study is testing the safety and blood-related effects of Zola-cel (BMS-986353) given with fludarabine and cyclophosphamide in people with cITP or AIHA. Key outcomes include treatment-emergent and serious adverse events, measures of blood response (complete and overall response), timing and durability of responses, need for rescue therapy, and patient-reported measures such as fatigue and quality of life.
What the researchers hope to learn. Scientific goals: evaluate safety (treatment-emergent adverse events, serious adverse events, adverse events of special interest, laboratory abnormalities); measure hematologic responses (complete response, partial response, overall response), time to response and duration of response; track treatment-free remission and need for rescue therapy; assess hemolysis indicators and specific features in CAD; and collect patient-reported outcomes such as fatigue and quality-of-life changes.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Fludarabine Phosphate
- Cyclophosphamide
- Biological
- BMS-986353
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Inclusion Criteria for ITP
- Documented clinical diagnosis of chronic ITP (cITP) without other clinical manifestations of systemic autoimmune disease.
- Has relapsed after or is intolerant to corticosteroids (with or without intravenous immunoglobulin (IVIG) or anti-Rh0(D) Ig) AND has failed, relapsed after, or is intolerant to therapies with ≥ 2 mechanisms of action, with at least one being immunosuppressive or immunomodulatory.
- Platelet count < 30 × 109/L. For participants on thrombopoietin receptor agonist (TPO-RA): platelet count < 50 × 109/L.
- Inclusion Criteria for AIHA
- Documented clinical diagnosis of AIHA (including warm autoimmune hemolytic anemia (wAIHA), cold agglutinin disease (CAD), or mixed AIHA) without other clinical manifestations of systemic autoimmune disease.
- o wAIHA and mixed warm and cold AIHA: Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action (not including corticosteroids or IVIG), one of which is an anti-CD20 monoclonal antibody unless there is a documented contraindication.
- o CAD (all of the following must apply): Failed, relapsed after, or is intolerant to at least 2 prior lines of treatment with 2 mechanisms of action, one of which is an anti-CD20 monoclonal antibody with or without chemotherapy unless there is a documented contraindication.
- Hb <10 g/dL without red blood cell transfusion, or transfusion dependent
- Documented hemolysis
Exclusion criteria
- Medical Conditions
- ITP or AIHA associated with: Evans syndrome, other systemic autoimmune disease or single organ autoimmune disease requiring systemic immunosuppressive therapy, hepatitis C virus, HIV, drug induced (eg, non-steroidal anti-inflammatory drug (NSAIDS), trimethoprim/sulfamethoxazole (TMP-SMX), anticonvulsants), surgical procedures, or hematologic malignancies.
- COVID-19 Vaccine-induced immune thrombotic thrombocytopenia
- Prior history of solid organ malignancies, unless the participant has been free of the disease for ≥ 2 years.
- Laboratory Test Findings
- Peripheral blood ANC < 1.5 × 109/L or requiring G-CSF or GM-CSF support o ALT/AST: ITP: ALT/AST: > 3 × ULN AIHA: ALT > 3 ULN. AST up to 5 × ULN may be permitted. o Bilirubin: ITP: total bilirubin > 1.5 × ULN AIHA: direct bilirubin > 1.5 × ULN o International normalized ratio (INR) > 1.5 × ULN
- Other protocol-defined inclusion/exclusion criteria may apply.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by an infusion of Zola‑cel (BMS‑986353). They will have frequent blood tests and safety monitoring, assessments of blood counts and hemolysis, and complete questionnaires about symptoms and quality of life. Hematologic response is assessed especially during the first ~6 months; safety follow‑up and some outcome measurements continue for up to about 36 months. The registry record does not provide a complete visit schedule or every required test.
How the study is structured. Interventional Phase 2, open-label, single-group, non-randomized study. Participants receive Zola-cel (BMS-986353) plus fludarabine and cyclophosphamide as specified; safety and blood-response outcomes are tracked over scheduled visits, with some outcomes followed up to approximately 36 months.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in Denmark, Germany, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Aug 31, 2026 (estimated)
- Primary completion
- May 6, 2030 (estimated)
- Study completion
- May 6, 2030 (estimated)
- Target enrollment
- 52 participants (estimated)
- Last updated on registry
- Jul 9, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com 📞 855-907-3286 ✉ Clinical.Trials@bms.com
- First line of the email MUST contain NCT # and Site #.
Participating sites (8)
- Local Institution - 101
Boston, Massachusetts, 02114 · United States
- Site 101
- Local Institution - 103
Houston, Texas, 77030-2740 · United States
- Site 103
- Local Institution - 102
Seattle, Washington, 98109 · United States
- Site 102
- Local Institution - 201
Odense, DK-5000 · Denmark
- Site 201
- Local Institution - 301
Magdeburg, Saxony-Anhalt, 39120 · Germany
- Site 301
- Local Institution - 302
Erlangen, 91054 · Germany
- Site 302
- Local Institution - 401
London, Greater London, W12 OHS · United Kingdom
- Site 401
- Local Institution - 402
Sheffield, S10 2SJ · United Kingdom
- Site 402
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- relapsed
- A condition that improved with treatment and has since returned or worsened.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- prior lines
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- ANC
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- × ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials