Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma

Who can take part

• Have the capacity to give informed consent
• Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria
• Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment)
• Refractory and relapsed MM patients after > 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT)
• ECOG score=0-2

Who cannot take part

• Participate in other clinical research in the past three months; previously treatment with any gene therapy products
• Contraindication to cyclophosphamide or fludarabine chemotherapy
• Active infection, HIV infection, syphilis serology reaction positive
• Active hepatitis B, hepatitis C at the time of screening
• Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis serious mental disorder
• With severe cardiac, liver, renal insufficiency, diabetes and other diseases
• Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy
• Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)> 5 x upper limit of normal; bilirubin > 3.0 mg/dL