This is an open label, single-site, dose-escalation study in up to 18 participants with refractory autoimmune diseases. This study aims to evaluate the safety and efficacy of the treatment with Anti-BCMA and CD19 CART
Sign the informed consent form.
At the time of signing the informed consent form, the age of 18 years old or above, both male and female.
Bone marrow hematopoietic function is satisfied: white blood cell count ≥3×10^9/L; neutrophil count ≥1×10^9/L (not receiving colony-stimulating factor within 2 weeks prior to screening); hemoglobin ≥60g/L.
Liver function fulfillment: ALT≤3×ULN; AST≤3×ULN; TBIL≤3×ULN.
pre-screening presence of clinically significant CNS disease or pathological changes not caused by the disease itself, including, but not limited to: stroke, apoplexy, aneurysm, epilepsy, convulsions, aphasia, severe craniocerebral injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndromes, or insanity.
Those suffering from relatively serious heart diseases such as angina pectoris, myocardial infarction, heart failure and arrhythmia.
History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation.
vaccination, B-cell targeted therapy within 4 weeks prior to screening.
Sequential
Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.
DrugA single intravenous infusion of anti-BCMA and CD19 CART cells (dose-escalating infusion of 0.5-3 x10\^6 CART cells/kg）.
Adverse events
Total number, incidence and severity of adverse events (AEs) in patients of SCAR02 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus.
The persistence, accumulation, and migration of Anti-BCMA and CD19 CART cells
Assessing the trafficking of Anti-BCMA and CD19 CART cells in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline.
Erythrocyte Sedimentation Rate
To evaluate disease activity
American College of Rheumatology (ACR) criteria 20, 50, 70 response rate
To evaluate RA disease activity
Swollen and tender joint count
To evaluate RA disease activity
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