drugset / Trial / NCT04878484

Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors

NCT04878484 ↗

Phase 1 Withdrawn Athenex, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1. This study will investigate the safety, tolerability, activity, and pharmacokinetics/ pharmacodynamics of TCRT-ESO-A2 infusion. A maximum tolerated dose study of TCRT-ESO-A2 in subjects with advanced malignancies expressing NY-ESO-1 is considered to be an acceptable risk. Once safety, tolerability, and pharmacokinetic/pharmacodynamic data are available, the activity of TCRT-ESO-A2 in NY-ESO-1-positive tumors may be explored further.

Timeline

Start
2021-08-11
Primary completion
2022-10
Completion
2024-12

Outcome

Outcome not reported

Stopped (Enrollment): “Poor recruitment”

Drugs

EvaluationDrugModalityDoseRoute
Subject TCRT-ESO-A2 Cell therapy 3e+09 cells Intravenous
Subject TCRT-ESO-A2 Cell therapy 1e+10 cells Intravenous
Subject TCRT-ESO-A2 Cell therapy 3e+10 cells Intravenous

Indications