NCT02976857

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

A Phase 1 Single Center, Non-randomized Study Evaluating Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T-cell (C-CAR011) Treatment in Subjects With Refractory Diffuse Large B-cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Detailed 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).

Conditions

• Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	C-CAR-011	lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-09-11
• Completion: 2019-01-09
• First posted: 2016-11-29
• Last updated: 2019-01-17

Locations

1 site across 1 country: China