NCT03497533

Treatment of Refractory/Relapsed Non-Hodgkin Lymphoma With TriCAR-T_CD19

TriCAR-T-CD19 Adoptive Immunotherapy for CD19-positive Refractory/Relapsed Non-Hodgkin Lymphoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Timmune Biotech Inc. · Industry
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, single-center, phase 1/2 study, to determine the safety and efficacy of TriCAR-T-CD19, an autologous tri-functional anti-CD19 chimeric antigen receptor (CAR)-positive T cell therapy, in refractory/Relapsed Non-Hodgkin Lymphoma (NHL).

Detailed description

The tri-functional anti-CD19 chimeric antigen receptor contains an anti-CD19 scFv, a PD-L1 blocker, and a cytokine complex, enabling the TriCAR-T-CD19 to simultaneously targeting the CD19 positive NHL，blocking the inhibitory PD-L1 signal and stimulating T/NK cell activation and expansion.

Conditions

• Non-hodgkin Lymphoma,B Cell

Interventions

Type	Name	Description
BIOLOGICAL	TriCAR-T-CD19	A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.5-1 x 10\^6 CAR+ T cells/kg

Timeline

• Start date: 2018-08-03
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2018-04-13
• Last updated: 2019-09-06

Locations

1 site across 1 country: China