YTS104 Cell Injection for the Treatment of Relapsed or Refractory Multiple Myeloma
Trial Parameters
Brief Summary
This is a single-center, single-arm, open-label phase I clinical study to determine the safety and efficacy of relapsed or refractory multiple myeloma subjects
Eligibility Criteria
Inclusion Criteria: * Aged 18-75 years, gender is not limited; * Patients diagnosed as relapsed/refractory multiple myeloma according to the International Myeloma Working Group (IMWG 2014) criteria for multiple myeloma after at least 3 lines of treatment (including at least one proteasome inhibitor and an immunomodulator based chemotherapy regimen), and at least one complete treatment cycle per line of treatment; Documented disease progression during or within 12 months after the most recent antimyeloma therapy (not limited to 12 months after CAR-T therapy as the last line of therapy); * The presence of one or more measurable lesions at screening was defined as any of the following: 1) serum M-protein ≥0.5g/dL (≥5g/L), 2) urinary M-protein level ≥200 mg/24 hours; 3) serum free light chain (sFLC) ≥100 mg/L and serum κ/λ free light chain ratio abnormal (\<0.26 or \>1.65); * Good organ function; * ECOG score ≤1; * The predicted survival time was ≥12 weeks; * Female subjects of childbearin