NCT06733610 CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
| NCT ID | NCT06733610 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Autoimmune Hemolytic Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2024-12-05 |
| Primary Completion | 2026-02-05 |
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 2024-12-05 with a primary completion date of 2026-02-05.
⚠ 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: * Age ≥ 18 years * Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood. * 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)" * 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, and biologics including daratumumab, BTK inhibitors, Syk inhibitors, and complement inhibitors. * ECOG ≤ 2 * Functional requirements for major organs are as follows: 1. . The bone marrow function needs to meet: a Neutrophil count ≥ 1.0 × 10 \^ 9/L; b. Platelets ≥ 30 × 10 \^ 9/L. 2. Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN； Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN). 3. Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself). * Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating. * Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: * Subjects with a history of severe drug allergies or allergic tendencies. * Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections. * Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis). * Subjects with insufficient cardiac function * Subjects with congenital immunoglobulin deficiencies * History of malignancy within five years * Subjects with end-stage renal failure * Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing * Subjects with psychiatric disorders and severe cognitive impairments * Subjects who have used immunosuppressive agents or biologics with therapeutic effects on the disease within five half-life before enrollment * Pregnant women or women planning to conceive * Active infection, active rheumatic and immune disease, drug induced and diagnosed lymphoproliferative tumor associated secondary AIHA patients * Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06733610 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying 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 NCT06733610 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 NCT06733610 currently recruiting?
Yes, NCT06733610 is actively recruiting participants. Contact the research team at shijun@ihcams.ac.cn for enrollment information.
Where is the NCT06733610 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06733610 clinical trial?
NCT06733610 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 15 participants.