A Dose Escalating Study of CD19/CD22/BCMA CAR-T Therapy in Relapsed/ Refractory Multiple Myeloma
Trial Parameters
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and tolerability of autologouschimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA in patients with relapsed/refractory multiple myeloma.
Eligibility Criteria
Inclusion Criteria: * Participants must meet all of the following criteria in order to be enrolled: 1. Understand and voluntarily sign an informed consent form (ICF) before conducting any research related evaluations/procedures; 2. Age range: 18-75 years old; 3. Expected survival period is not less than 12 weeks; 4. ECOG score ≤ 2 points; 5. The bone marrow flow cytometry results showed positive BCMA antigen (including weak positive, moderate positive, and strong positive); 6. According to the IMWG criteria, a diagnosis of multiple myeloma with measurable lesions must meet at least one of the following criteria: 1. Serum M protein (SPEP) ≥ 5g/L 2. 24-hour urinary M-protein excretion rate ≥ 0.2g (200mg) 3. Serum free light chain (sFLC) ≥ 100 mg/L and abnormal free light chain ratio 4. The ratio of primitive plasma cells to immature plasma cells in bone marrow cytology examination is greater than 5%, or the flow cytometry detection of monoclonal plasma cells is greater than 5% 7. Those w