Phase I/II Open-label Study Evaluating The Safety And Efficacy of Anti BCMA CAR-T Cell Therapy in Adults With R/ R Multiple Myeloma
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
• Male or female, aged ≥18 years.
• Willing and able to give written, informed consent.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.
• Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators.
• 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.
• Have no active GVHD (Grade 2-4)
• 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 × 10\^9/L