Study Design and Patients
MM
DISEASES, INFECTIONS, MYELOMA
We conducted a single-center, single-arm, phase Ⅱ trial of anti-GPRC5D CAR T cells in patients with R/R MM from September 1, 2021, to March 23, 2022 (Chinese Clinical Trial Register: ChiCTR2100048888). The study was approved by the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University. Written informed consent was obtained from each patient before study entry in accordance with the Declaration of Helsinki. Eligible patients were between age 18 and 70 years, had histologically confirmed MM, a Karnofsky Performance score of 50 points or more, and a life expectancy of more than 12 weeks without active infections, serious liver, heart, and other diseases, and met the International Myeloma Working Group diagnostic criteria for R/R MM,Lymphocytes were isolated from the enrolled patients using a blood cell separator, and T lymphocytes were sorted using anti-CD3 immunomagnetic beads. The antigen recognition domain of the YK-GPRC5D BB-002 vector was obtained from a human antibody phage display library. The CAR construct was composed of single-chain variable fragment, a CD8α hinge, and transmembrane domains, 4-1BB costimulatory and CD3ζ activation domains. CD3-positive T cells were transfected with lentiviral vectors for stable expression of CARs. Transduction efficiency was determined by flow cytometric analysis between days 7 and 10 and confirmed on the day of CAR T-cell infusion (Data Supplement, online only). The expression of GPRC5D was detected by flow cytometry. Lymphodepletion regimen was performed using fludarabine (30 mg/m