A Multicenter Clinical Study on the Safety and Efficacy of Nanobody-based Biepitope CAR-T Cells Targeting BCMA in the Treatment of Relapsed/Refractory Multiple Myeloma
To explore the safety and efficacy of nanobody-based BCMA-targeting biepitope CAR-T cells in the treatment of relapsed/refractory multiple myeloma，this study will be conducted in multiple study centers, with 60 patients openly enrolled to receive CAR-T cell therapy. Patients participating in clinical trials will be tested and evaluated for treatment safety, efficacy, duration of response, and long-term survival.
• Patient or his or her legal guardian voluntarily participates in and signs an informed consent form.
• Aged ≥ 18 years and ≤ 75 years.
• Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG 2014).
• Diagnosed as relapsed/refractory disease or primary refractory disease; relapse is defined as disease progression within 60 days of the most recent treatment with three or more lines of therapy with different mechanisms of action; refractory is defined as failure to achieve MR or above efficacy with prior treatment and disease progression with recent treatment, or disease progression within 60 days of treatment.
• Flow cytometry or immunohistochemistry showed positive BCMA expression in myeloma cells.
• Have not been treated with antibody-based drugs within 2 weeks prior to cell therapy.
• ECOG score 0-2 points.
• HGB≥70g/L，PLT≥30×10\^9/L.
• Liver, kidney and cardiopulmonary functions meet the following requirements:
‣ Serum creatinine ≤ 1.5× ULN or creatinine clearance (Cockcroft-Gault) \>30 ml/min；
⁃ Left ventricular ejection fraction (LVEF) ≥50%,
⁃ Baseline peripheral oxygen saturation \> 90%;
⁃ Total bilirubin ≤ 1.5×ULN; ALT and AST ≤2.5×ULN.