Clinical trial for the safety and efficacy of CD19 CAR-T following autologous hematopoietic stem cell transplantation (ASCT) for Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (R/R B-NHL) with High-Risk Prognostic Factors
Histologically confirmed B-cell non-Hodgkin's lymphoma including the following types
diffuse large B-cell lymphoma
high-grade B-cell lymphoma with or without MYC and BLC2 and/or BCL6 rearrangement
transformed lymphoma
History of autologous or allogeneic stem cell transplantation
Active HBV or HCV infection, defined as HBV-DNA or HCV-DNA levels above the normal upper limit, with or without abnormal liver function. Individuals with positive HBsAg or HBcAb should receive antiviral prophylaxis for at least 12 months after CAR-T cells infusion.
Presence of uncontrolled infection, cardio-cerebrovascular disease，coagulopathy, or connective tissue disease.
History of HIV infection
Single group
autologous stem-cell transplantation
Other interventionhigh-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT)
Relmacabtagene autoleucel (relma-cel)
Drugrelma-cel (CD19 CAR-T cell)infusion on day 3(±1d) after ASCT with a fixed dose of 100X10\^6.
Best Complete Response (CR) Rate in 3 months
Best Complete Response rate in 3 months is defined as the incidence of subjects achieving complete remission (CR) within 3 months after CAR-T infusion according to the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
Objective remission rate (ORR) in 3months
ORR in 3 moths is defined as the incidence of either a CR or a partial response (PR) within 3 months after CAR-T infusion per the Lugano Classification as determined by study investigators.
Duration of Response (DOR)
DOR is defined only for participants who experience an objective response after CAR-T infusion and is the time from the first objective response to disease progression or death from any cause
Progression-Free Survival (PFS)
PFS is defined as the time from the CAR-T infusion date to the date of disease progression or death from any cause.
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death from any cause.
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