NCT07530380 UCAR T-cell Therapy Targeting CD19/BCMA in Relapsed/Refractory Autoimmune Hemolytic Anemia
| NCT ID | NCT07530380 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The Second Hospital of Anhui Medical University |
| Condition | AIHA - Warm Autoimmune Hemolytic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-04 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-04 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy
Eligibility Criteria
Inclusion Criteria: * 1\. Age ≥ 10 years, regardless of sex; * 2\. Flow cytometry-confirmed CD19 or BCMA positivity on B cells in peripheral blood or bone marrow; * 3\. Patients diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other types of AIHA, with diagnostic criteria referring to the "Chinese Adult Autoimmune Hemolytic Anemia Diagnosis and Treatment Guidelines (2023 Edition)"; * 4\. The definition of recurrent/refractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\<100g/ L) that persists after a routine treatment cycle of at least 6 months and is still ineffective or reappears after disease remission. The definition of conventional treatment: treatment with glucocorticoids and/or rituximab, as well as any 1-2 or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine A, azathioprine, danazol, bendamustine, fludarabine, bortezomib, a
Frequently Asked Questions
Who can join the NCT07530380 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, studying AIHA - Warm Autoimmune Hemolytic Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07530380 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07530380 currently recruiting?
Yes, NCT07530380 is actively recruiting participants. Visit ClinicalTrials.gov or contact The Second Hospital of Anhui Medical University to inquire about joining.
Where is the NCT07530380 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT07530380 clinical trial?
NCT07530380 is sponsored by The Second Hospital of Anhui Medical University. The trial plans to enroll 15 participants.