drugset
drugset / Trial / NCT02134262

Gene Therapy for B-Cell Non-Hodgkin Lymphoma Using CD19 CAR Gene Transduced T Lymphocytes

NCT02134262 ↗

Phase 1/2 Unknown 18 enrolled Jichi Medical University Takara Bio Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express anti-CD19 Chimeric Antigen Receptor in patients with relapsed or refractory B-Cell Non-Hodgkin Lymphoma.

Timeline

Start
2014-05
Primary completion
2017-03
Completion
2017-03

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19 CAR-T Cell therapy 300000 cells/kg Intravenous
Subject CD19 CAR-T Cell therapy 1e+06 cells/kg Intravenous
Subject CD19 CAR-T Cell therapy 3e+06 cells/kg Intravenous
Subject CD19 CAR-T Cell therapy 1e+07 cells/kg Intravenous
Background Bendamustine Small molecule 120 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 1.5 g Intravenous

Indications

B-cell non-Hodgkin lymphoma