drugset / Trial / NCT04878484
Evaluate TCRT-ESO-A2 Autologous T Cells Expressing TCR Specific for NY-ESO-1 in Subjects With Advanced Solid Tumors
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |