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

2016-11-30 15:45:12 | BioPortfolio

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

Description

The 3x3 dose escalation design will be adopted in order to determine the maximum tolerated dose (MTD). Subjects will be enrolled into low-dose group, medium-dose group and high-dose group as below:

Dose CAR+ cells/kg

Low 0.8×106

Medium 2.5×106

High 5.0×106

DLT is evaluated within 30 days post C-CAR011 infusion).

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Refractory Diffuse Large B-Cell Lymphoma

Intervention

C-CAR-011

Location

Hematological Department, People's Hospital of Jiangsu Province
Nanjing City
Jiangsu
China
210029

Status

Not yet recruiting

Source

Cellular Biomedicine Group Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-11-30T15:45:12-0500

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