An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
• ≥18 years old;
• Sign on the informed consent;
• Subjects must have histologically confirmed Large B-cell Lymphoma;
• Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);
• Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
• Adequate organ function;
• Adequate vascular access for leukapheresis procedure;
• Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
⁃ Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
⁃ Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.