About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- universal allogeneic anti-CD19/BCMA CAR T-cells