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
This is a single-center, single-arm, open-label, prospective clinical trial to evaluate the efficacy and safety of CD19 CAR-T infusion following high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) in relapsed or refractory B-cell Non-Hodgkin's Lymphoma patients with high-risk prognostic factors (extranodal involvement/bulky mass ≥5 cm in diameter/TP53 alterations). CD19 CAR-T will be infused on day +3 (±1d) with a fixed dose of 100X10\^6. The study will assess the safety and efficacy of this combinational therapy, including the investigators assessed the best complete response rate (BCR) in 3 months (primary endpoint), objective response rates, survivals, incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities of the subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT)
relma-cel (CD19 CAR-T cell)infusion on day 3(±1d) after ASCT with a fixed dose of 100X10\^6.
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
RECRUITINGBest 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.
Time frame: 3months post CAR-T infusion
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.
Time frame: 3months post CAR-T infusion
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
Time frame: 2 years post CAR-T infusion
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.
Time frame: 2 years post CAR-T infusion
Overall Survival (OS)
OS is defined as the time from CAR-T infusion to the date of death from any cause.
Time frame: 2 years post CAR-T infusion
Adverse Events rate as assessed by CTCAE version 5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
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Time frame: 2 years post CAR-T infusion