NCT03994913

Clinical Trial to Evaluate CD19 CAR T (CT032) in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma

An Open, Multi-center Phase Ⅰ/II Clinical Study to Evaluate the Safety and Efficacy of CT032 Humanized CD19 Autologous Car T Cell Injection in Patients With Relapsed and/or Refractory Non-Hodgkin's B Cell Lymphoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: CARsgen Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT032 CAR-CD19 T in patients with relapsed and/or refractory non-Hodgkin's B cell lymphoma (R/R B-NHL).

Detailed description

This study is a single-arm, open label, phase I/II clinical trial to evaluate the safety, efficacy and cellular kinetics of CT032 CAR-CD19 T cells in patients with R/R B-NHL. The study is composed of two stages, Phase I stage is for dose escalation and recommendation of phase 2 dose, and Phase II stage is to verify the efficacy and safety of the dose proposed.

Conditions

• Refractory B-Cell Non-Hodgkin Lymphoma
• Relapsed B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CAR-CD19 T Cells	The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19. Fludarabine and Cyclophosphamide are used for lymphodepletion.

Timeline

• Start date: 2019-08-14
• Primary completion: 2021-01-20
• Completion: 2021-05-27
• First posted: 2019-06-21
• Last updated: 2023-04-14

Locations

2 sites across 1 country: China