NCT02965092

CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies

Treatment of Relapsed or Refractory B-cell Malignancies by CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wuhan Sian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, phase 1/2 study to evaluate the safety and efficacy of anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. CAR consists of single chain variable fragment (scFv) and activation domain of T cell. In preclinical study, the researchers constructed a second generation CAR containing CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Conditions

• Acute Lymphoblastic Leukemia
• B Cell Lymphoma

Interventions

Type	Name	Description
GENETIC	Second generation CAR-T cells

Timeline

• Start date: 2015-12-02
• Primary completion: 2021-01-01
• Completion: 2021-12-01
• First posted: 2016-11-16
• Last updated: 2019-05-10

Locations

1 site across 1 country: China