This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
1.Age ≥ 18 years old (inclusive), regardless of gender.
2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 ^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 ^ 9/L.
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≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
1.Subjects with a history of severe drug allergies or allergic constitutions;
2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections;
3. Subjects with insufficient cardiac function;
4. Subjects with congenital immunoglobulin deficiencies;
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
AIHA：Rates of CR, CRi, PR, ORR
CR: complete response CRi: Complete Remission with incomplete and compensated hemolysis PR: Partial response ORR: Overall response rate
SLE：SLE Response Index 4 (SRI-4)
The SRI-4 (SLE Responder Index-4) response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (\<0.3 points worsening from the baseline level).
SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
SSc：Change in the modified Rodnan Skin Score (mRSS) from baseline
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
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