NCT02735291

Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia

Single Arm, Two Phase, Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Sinobioway Cell Therapy Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.

Detailed description

This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for recurrent or refractory acute non T lymphocyte leukemia.The study will be conducted using a phase I/II design.The study will have the following sequential phases:Part A (screening leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study is expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19-targeted CAR-T cells	This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..

Timeline

• Start date: 2015-11-01
• Primary completion: 2019-12-01
• Completion: 2025-12-01
• First posted: 2016-04-12
• Last updated: 2020-07-15

Locations

2 sites across 1 country: China