NCT03018093

A Phase I Study Evaluating Safety and Efficacy of C-CAR011 Treatment in Adult Subjects With r/r CD19+B-ALL

A Phase I Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Adult Subjects With Relapsed/Refractory CD19+ B Cells Acute Lymphoblastic Leukemia(CALL-1)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Shanghai AbelZeta Ltd. · Industry
• Sex: All
• Age: 14 Years – 75 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 adult subjects with relapsed/refractory CD19+ B cells acute lymphoblastic leukemia(r/r CD19+B-ALL)

Detailed description

This is a single-center, Open Label phase I clinical trial, 20 subjects planned to be enrolled. The trial have two stages (Phase I dose-escalation clinical trial and phase I dose expansion trial).Subjects will be divided into low-dose group, medium-dose group and high-dose group.Additional patients will be enrolled to confirm the optimal dose Dose CAR+ cells/kg Low 0.5×106 Medium 1.5×106 High 3.0×106

Conditions

• Relapsed or Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	C-CAR-011	CD19-targeted chimeric antigen receptor T cells

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-08-01
• Completion: 2018-11-01
• First posted: 2017-01-11
• Last updated: 2017-01-20

Locations

1 site across 1 country: China