a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Trial Parameters
Brief Summary
This is a single arm study to evaluate the efficacy and safety of BCMA-targeted prime CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. Evidence for cell membrane BCMA expression 4. All genders, ages: 18 to 75 years# 5. The expect time of survive is above 3 months; 6. KPS\>60 7. No serious mental disorders ; 8. Left ventricular ejection fraction ≥50% 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 10. Sufficient renal function defined by creatinine clearance≤2 x ULN; 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications; 13\. Ability and willingness to adhere to the study visit schedule and all protocol requi