Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
Trial Parameters
Brief Summary
The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma
Eligibility Criteria
Inclusion Criteria: 1. Male or female, aged ≥18 years. 2. Willing and able to give written, informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2. 4. Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators. 5. Adequate organ system function including \- Creatinine clearance ≥30 cc/min. \- Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN). \- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome. \- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \[ECHO\] or \- Baseline oxygen saturation \>92% on room air and ≤Grade 1 dyspnoea. 6. Have no active GVHD (Grade 2-4) 7. Adequate bone marrow (BM) function * Absolute neutrophil count ≥1.0 × 10\^9/L. * Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis). * Haemoglobin ≥80 g/L. * Platelets ≥50 × 1