Phase I Study of A CXCR4 Modified BCMA CAR-T in Patients With Refractory and/or Relapsed Multiple Myeloma
Multiple myeloma (MM) is an incurable plasma cell cancer that almost all patients eventually relapse despite advancement in treatment strategies. B-cell maturation antigen (BCMA) is a cell surface receptor that expressed primarily by malignant and normal plasma cells. This study aims to evaluate the safety and tolerance CXCR4 modified BCMA CAR T cells in treating standard treatment failed refractory/relapsed multiple myeloma, and will follow dose-escalating cohorts. The efficacy of CXCR4 modified BCMA CAR T will also be investigated.
• Male or female, 18 to 75 years old.
• The expected survival ≥ 12 week
• ECOG ≤ 2
• Patients with multiple myeloma that never achieved MR (minor response) or received ≥ 1 line of standard therapy but tumor relapse
• The liver and renal function is good/adequate organ function; no uncontrolled or active infectious disease
• Venous channel is unobstructed, which can meet the needs of intravenous drip; no contraindications of mononuclear cell collection
• Patients can take effective contraceptive measures during the trial period and 1 year after the infusion
• Voluntary informed consent is given, agree to follow the trial treatment and visit plan