CAR T-cell Therapy Targeting CD19 and BCMA in Patients With B cell mediated autoimmune disease.
Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; b. Hemoglobin ≥ 60 g/L; c. Platelet count ≥ 30 × 10⁹/L.
Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).
Renal Function: eGFR ≥ 30 mL/min/1.73 m².(Participants with eGFR < 30 mL/min/1.73 m² and/or those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)
Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.
1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.
Single group
UCAR T-cell
Biological/VaccineUniversal allogeneic anti-CD19/BCMA CAR T-cells.
The number and severity of dose-limiting toxicity (DLT) events
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.
Cmax of CAR-T cells [PK parameter]
The peak plasma concentration (Cmax) of amplified UCAR-T cells in peripheral blood after infusion.
Tmax of CAR-T cells [PK parameter]
The time of amplified UCAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
AUC 0-28d of UCAR-T cells [PK parameter]
The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d).
The degree of B cell depletion [PD parameter]
The degree of B cell depletion at various time points.
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