BCMA-Targeted CAR-T Cell Therapy for Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Inclusion criteria

• 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.

Exclusion criteria

• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Evidence of disorder that need the treatment by glucocorticoids;
• Active or chronic GVHD；
• The patients treatment by inhibitor of T cell；
• Pregnant or breasting-feeding women;
• Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.