The primary objective of this study is to explore the safety and efficacy of CNCT19 (a second-generation anti-CD19 CAR T-cell using 4-1BB as co-stimulatory domain provided by Juventas, Tianjin, China) infusion following ASCT in patients with relapsed or refractory B-cell lymphoma.
This is a single-center, non-randomized, open-label, prospective clinical trial to evaluate the safety and efficacy of CNCT19 infusion following high-dose chemotherapy and autologous stem-cell transplantation (HDT/ASCT) in patients with relapsed or refractory B-cell lymphoma. CNCT19 cells will be infused on day +3 (±1d) with a fixed dose of 2×10\^6/kg. The study will assess the safety and efficacy of this combinational therapy, including the incidence and severity of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological, and other non-hematological toxicities, and objective response rates and complete response rates and survivals of the subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
Percentage of participants experiencing adverse events
Time frame: from the first day of high-dose chemotherapy until 2 years post CNCT19 infusion
Complete Response (CR) Rate
Complete Response rate is defined as the incidence of a CR per the Lugano Classification (Cheson et al, 2014), as determined by study investigators.
Time frame: 2 years post CNCT19 infusion
Objective Response Rate (ORR)
ORR is defined as the incidence of either a CR or a partial response (PR) per the Lugano Classification as determined by study investigators.
Time frame: 2 years post CNCT19 infusion
Progression-Free Survival (PFS)
PFS is defined as the time from the CNCT19 infusion date to the date of disease progression or death from any cause.
Time frame: 2 years post CNCT19 infusion
Duration of Response (DOR)
DOR is defined only for participants who experience an objective response after CNCT19 infusion and is the time from the first objective response to disease progression or death from any cause.
Time frame: 2 years post CNCT19 infusion
Disease-Free Survival (DFS)
DFS is defined only for participants who achieve complete response after CNCT19 infusion and is the time from complete response to disease progression or death from any cause.
Time frame: 2 years post CNCT19 infusion
Overall Survival (OS)
OS is defined as the time from CNCT19 infusion to the date of death from any cause.
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60mg/m2, day -3, -2
Time frame: 2 years post CNCT19 infusion