Study Evaluating the Efficacy and Safety With CAR-T Immunotherapy for CD19 Positive Lymphoma — EECPL  

Lymphoma Clinical Trial

Official title: Open, Single Arm,Multicenter Phase 2 Clinical Study to Evaluating the Efficacy and Safety of the Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) for CD19 Positive Lymphoma

Status Not yet recruiting

Clinical Trial Summary

This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma 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 modified to express the CD19 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 for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.

Clinical Trial Description

This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign 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 are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years. ;

Related Conditions & MeSH terms

• Lymphoma

• NCT number: NCT03086954
• Study type: Interventional
• Source: Sinobioway Cell Therapy Co., Ltd.
• Contact: Jifeng Feng, Professor
• Phone: 13901581264
• Email: fjif@vip.sina.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 2017
• Completion date: March 2021