A Clinical Study to Evaluate the Safety and Efficacy of BCMA-GPRC5D CAR-T in Patients With R/R MM Who Received Three or More Lines of Therapy
This is a single-center, open-label, single-arm study to evaluate the safety and efficacy of bispecific BCMA-GPRC5D Chimeric antigen receptor (CAR) T-cells in patients with relapsed or refractory multiple myeloma who received three or more lines of therapy.
• Patient or his or her legal guardian voluntarily participates in and signs an informed consent form;
• Aged ≥ 18 years and ≤ 75 years;
• Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG);
• The presence of measurable disease at screening meets one of the following criteria:Serum M-protein ≥ 1.0 g/dL or Urine M-protein ≥ 200 mg/24h or diagnosed as Light-chain MM without measurable disease in serum and urine; Serum free light chain ≥ 10 mg/dL with an abnormal κ/λ ratio;
• Patients must relapse or be refractory after three or more lines of therapy, which at least include: one Proteasome Inhibitor (PI), one Immunomodulatory Drug (IMiD), and one anti-CD38 monoclonal antibody;
• diagnosed as relapsed/refractory disease or primary refractory disease;
• The last treatment is ineffective, or the disease progresses within 60 days after the end of the last therapy;
• Patients must recover from the toxicity of the last therapy (\< grade 2 by CTCAE criteria);
• ECOG score 1-2 points and the expected survival period ≥ 3 months;
⁃ Liver, kidney and cardiopulmonary functions meet the following requirements:
∙ Total bilirubin ≤ 1.5×ULN, alanine aminotransferase (ALT) ≤ 3 × ULN and aspartate aminotransferase (AST) ≤ 3 × ULN;
‣ Serum creatinine ≤ 1.5×ULN, or creatinine clearance ≥ 60 mL/min;
‣ Hemoglobin (Hb) ≥ 50 g/L without prior blood transfusion within 7 days;
‣ Baseline peripheral oxygen saturation \> 92%;
‣ Corrected serum calcium ≤ 12.5 mg/dL (≤ 3.1 mmol/L) or free (ionized, ionic) calcium ≤ 6.5 mg/dL (≤ 1.6 mmol/L);
‣ Left ventricular ejection fraction (LVEF) \> 45%, without confirmed pericardiac effusion and abnormal electrocardiography with clinical significance;
‣ Without clinically significant pleural effusion;
⁃ Venous access could be established; without contraindications of apheresis.