Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

Subjects who meet the eligibility criteria, PBMC will be collected by blood cell separator and 50 mL of plasma will be collected for preparation of CAR-T and frozen storage of CAR-T preparations; patients will be treated with autologous BCMA CAR-T transfusion and followed up for a period of 3 years, with specific efficacy judgments referring to the IMWG Clinical Efficacy Evaluation Criteria.

Inclusion criteria

• Age 18-80 years, no gender restrictions;
• Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
• Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
• As judged by the investigator, the expected survival time is >3 months;
• ECOG performance status score ≤2, KPS >60%;
• The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin <34 μmol/L; creatinine clearance rate >30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;
• Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10^9/L, PLT >30×10^9/L, Hb >80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
• Those with fertility must agree to use highly effective contraceptive methods;
• The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

Exclusion criteria

• Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
• Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
• History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
• Previously received treatment targeting BCMA;
• Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
• Presence of uncontrolled active bacterial or fungal infection;
• Allergic to research-related drugs or cell components;
• Presence of active autoimmune diseases;
• Currently have unstable or active ulcers or gastrointestinal bleeding;
• Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
• Received other experimental drug treatments within the last 3 months;
• The researcher believes that for other reasons, the individual is not suitable for the clinical trial.