drugset / Trial / NCT05902520
Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors
Phase 1
Active not recruiting
18 enrolled
AgonOx, Inc.
Phio Pharmaceuticals Inc. · collabProvidence St Joseph Health · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The subject of this study is the adoptive transfer of selected autologous tumor infiltrating lymphocytes (TIL) after in vitro expansion for the treatment of solid tumor malignancies. The TIL selection process is based on evidence showing that CD8+ TIL which co-express both CD39 and CD103 harbor the bulk of tumor-reactivity and that the remaining CD8 TIL is mainly composed of non-tumor reactive bystander cells. All of the expanded TIL that are produced (1-40 billion are expected) will be delivered in the form of a cell suspension to the participants by intravenous infusion. It is proposed that these selected TIL will produce a more potent and efficacious treatment of late-stage cancer.
Timeline
- Start
- 2023-06-19
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DP CD8 TIL | Unknown | — | Intravenous |
| Subject | DP CD8 TIL KD | Unknown | — | Intravenous |
| Subject | Low dose IL-2 | Unknown | 5 unknown | Subcutaneous |