drugset / Trial / NCT02366546

Investigator Initiated Phase 1 Study of TBI-1301

NCT02366546

Non-randomizedSingle-groupOpen-labelTreatment

Summary

Following pre-treatment with cyclophosphamide and/or fludarabine, NY-ESO-1-specific TCR gene transduced T lymphocytes are transferred to the patients with NY-ESO-1-expressing solid tumors.

Timeline

Start
2015-03
Primary completion
2018-09
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject TBI-1301 Cell therapy 5e+08 cells
Subject TBI-1301 Cell therapy 5e+09 cells
Background Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Background Fludarabine Small molecule 20 mg/m2 Intravenous

Indications