Spots Global Cancer Trial Database for CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma

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Trial Identification

Brief Title: CNCT19 Following ASCT in Patients With Relapsed or Refractory B-cell Lymphoma

Official Title: CNCT19 Following Autologous Stem Cell Transplantation in Patients With Relapsed or Refractory Aggressive B-cell Lymphoma

Study ID: NCT04690192

Conditions

Large B-cell Lymphoma

Interventions

CNCT19

Gemcitabine Injection

busulfan

Melphalan Injection

Study Description

Brief Summary: 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.

Detailed Description: 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.