NCT02349698

A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Southwest Hospital, China · Academic / Other
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Detailed description

Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Chimeric Antigen Receptor Modified T cells Targeting CD19	T cells modified with CD19 targeted chimeric antigen receptor.

Timeline

• Start date: 2014-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2015-01-29
• Last updated: 2019-06-25

Locations

1 site across 1 country: China