This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Voluntarily participate in clinical research. The person or legal guardian fully understands and informs the research and signs the informed consent form (ICF), and is willing to follow and complete all trial procedures;
Aged 18-65 years old;
ECOG score ≤ 2 points;
Expected survival period is at least 12 weeks;
Have active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
Fungal, bacterial, viral or other infections exist or are suspected and are not controlled or require intravenous antibiotic treatment; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed;
Suffering from hepatitis B (hepatitis B virus surface antigen and hepatitis B DNA >1000 copies/ml) or hepatitis C (positive hepatitis C antibody test); syphilis infection (antibody positive); human immunodeficiency virus (HIV) infection;
CD19 targeted therapy;
Single group
anti-CD19-CAR-T cells
Biological/VaccineThe subjects received infusions of anti-CD19 CAR-T cells following completion of lymphodepleting preconditioning chemotherapy. Dosage：1×10\^5 cells/Kg; 3×10\^5 cells/Kg; 1×10\^6 cells/Kg frequency：single infusion
Incidence of dose-limiting toxicity
Percentage of patients receiving CAR-T cells who experience dose-limiting toxicities (DLTs).
Laboratory abnormalities and type, frequency and severity of adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards (CRS and neurotoxicity will be graded according to ASTCT/ ASBMT grading criteria)
Proportion of patients for whom a CAR-T cell product could be prepared
Percentage of subjects for whom the desired dose of anti-CD19 -CAR-T cells can be successfully manufactured
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Wenzhou Medical University
Lead sponsor
Shanghai First Song Therapeutics Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
