Clinical Study of the Safety and Efficacy of BCMA CAR-NK

Inclusion Criteria

• •Age 18 years or above, no gender preference.
• •Patients who have received at least 3 prior lines of treatment for multiple myeloma and have failed at least proteasome inhibitor and immunomodulator therapy; Each line has at least 1 complete treatment cycle unless the best remission status for that treatment is documented as progressive disease (PD) (as per the IMWG efficacy evaluation criteria published in 2016, Appendix 4); PD must be documented during or within 12 months after receiving the last treatment.
• •Presence of measurable lesions at screening, which are defined as any of the following situations:
• •Serum M protein≥1 g/dL (≥10 g/L) Urinary M protein≥200 mg/24 hours Serum free light chain (FLC): abnormal serum FLC ratio (\<0.26 or \>1.65) and involved FLC≥10 mg/dL (100 mg/L)
• •ECOG score (Appendix 1): 0\~1.
• •Expected survival≥3 months.
• •The following test values within 7 days prior to lymphocyte clearance meet the following criteria:
• •Hematology Absolute lymphocyte count:≥0.5×109/L\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period\] Absolute neutrophil count:≥1.0×10\^9 /L\[Granulocyte colony-stimulating factor (G-CSF) is allowed, but subjects should not have received this supportive therapy within 7 days prior to laboratory test during the screening period\].
• •Platelets:Subjects platelet count ≥50 x 10\^9/L (subjects must not receive transfusion support within 7 days prior to laboratory test during the screening period) Hemoglobin:≥8.0 g/dL (recombinant human erythropoietin is allowed) \[subjects have not received a red blood cell (RBC) transfusion within 7 days prior to laboratory test during the screening period\].
• •Liver Total bilirubin (serum) :Total bilirubin (serum) ≤1.5 × ULN AST and ALT:≤3× ULN
• •Peripheral venous pathway meets the requirements of intravenous drip.
• •Subjects agree to use reliable methods for contraception from the time of signing the informed consent till 1 year after the transfusion.
• •Voluntary participation in the clinical trial and signing of the informed consent form.