This is a multi-center, phase I/II study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.
≥19 years old, ECOG 0-2, life expectancy ≥12 weeks
Histologically confirmed B-cell lymphoma (WHO 2017)
Relapsed/refractory after ≥2 prior lines of systemic chemotherapy
≥1 measurable lesion (longest diameter ≥1.5 cm)
Unresolved ≥Grade 2 toxicities from prior therapy
Malignancy within 2 years except specified exceptions
Significant cardiac disease within 6 months
CNS involvement by lymphoma
Single group
TC011
DrugAnti-CD19 Chimeric Antigen Receptor T cell
Phase1: Occurrence of Dose-Limiting Toxicities (DLTs)
A dose-limiting toxicity (DLT) is defined as any toxicity that is definitely related or probably related to the administration of TC011. The severity of toxicities will be assessed according to CTCAE Version 5.0, while cytokine-release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) will be evaluated based on the American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading .
Phase1: Determination of Maximum Tolerated Dose (MTD)
DLT occurrence within the first 4 weeks after treatment initiation will be used to determine the maximum tolerated dose (MTD) .
Phase1: Determination of Recommended Phase 2 Dose (RP2D)
The recommended Phase 2 dose (RP2D) will be determined based on evaluation of safety (including DLT incidence), tolerability, overall adverse event profile, and preliminary anti-tumor activity observed during the dose-escalation phase.
Phase 1: The number and incidence rate of treatment-emergent adverse events (TEAEs) as well as serious adverse events (SAEs) will be assessed
All adverse events (AEs) will be graded according to CTCAE version 5.0. Adverse events of special interest include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria.
Phase 1: Overall response rate (ORR)
To explore the efficacy of the TC011, evaluate tumor response 4weeks and 12weeks after TC011 administration according to 2014 Lugano classification
Phase 2: Objective response rate (ORR)
Phase 2 Disease control rate (DCR)
Phase 2: Complete response rate (CRR)
Click on the lead sponsor to view all of their trials.
