a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease

Prior treatment

• The patients treatment by inhibitor of T cell

Other illness

• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Evidence of disorder that need the treatment by glucocorticoids;
• 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.

Other

• Active or chronic GVHD
• Pregnant or breasting-feeding women;

• 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%; 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 requirements.