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drugset / Trial / NCT02976857

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR011 Treatment in DLBCL Subjects

NCT02976857 ↗

Phase 1 Completed 15 enrolled Shanghai AbelZeta Ltd. The First Affiliated Hospital with Nanjing Medical University · collab

NaSingle-groupOpen-labelTreatment

Summary

The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR011 in treatment of refractory DLBCL

Timeline

Start: 2016-12
Primary completion: 2018-09-11
Completion: 2019-01-09

Publications

Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	C-CAR011	Cell therapy	0.8 cells/kg	—
Subject	C-CAR011	Cell therapy	2.5 cells/kg	—
Subject	C-CAR011	Cell therapy	5 cells/kg	—

Indications