CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
Age ≥ 18 years old (inclusive), regardless of gender.
Positive expression of CD19 or BCMA on peripheral blood B cells confirmed by flow cytometry.
Functional requirements for major organs are as follows（Except for abnormalities related to autoimmune disease activity）: 1) Bone marrow function must meet: A. Neutrophil count ≥ 1×109/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; 2) Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤2×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome); 3) Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded).
ECOG score 0-2.
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
UCAR T-cell
Biological/Vaccineuniversal 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
The total number, incidence, and severity of AEs
Clinical response of R/R AIDs
Clinical response of R/R AIDs
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Shanghai Xiniao Biotech Co., Ltd.
Collaborator
