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.
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.
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
Single group
universal allogeneic anti-CD19/BCMA CAR T-cells
Biological/VaccineA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells.
The number and severity of dose-limiting toxicity (DLT) events
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
The total number, incidence, and severity of AEs
Clinical response of AIHA who have failed ≥ 3 lines of therapy
Rates of CR, CRi, PR, ORR
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Xi'niao Biotech
Collaborator
