Exploratory Clinical Study on PD-1Ab21-BCMA CAR-T Cells (CD203) for First-line Consolidation Therapy of Multiple Myeloma With Renal Dysfunction
The purpose of this study is to determine the efficacy and safety of targeted BCMA CART cells secreting PD1 and interleukin 21 fusion protein immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction.
• Age: Over 14 years old
• Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months.
• The hospital examination meets the following indicators:
‣ ECOG physical status score 0-2 or KPS score\>80 points
⁃ Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications
⁃ WBC≥1×109/L，LY≥0.3×109/L，
⁃ ALT and AST ≤ 2.5 ULN
⁃ Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L)
⁃ PT:INR\<1.7 or PT prolonged by\<4s compared to normal value