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