About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Anti-BCMA and CD19 CART cells will be injected intravenously on a one-time basis.