Adoptive Cell Therapy Using Cancer Specific CD8+ Tumor Infiltrating Lymphocytes in Adult Patients With Solid Tumors
NCT05902520 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-01-08
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.
Conditions
- HNSCC
- Melanoma
- Gynecologic Cancer
- Colorectal Cancer
- Lung Cancer
- Urogenital Cancer
Interventions
- BIOLOGICAL
-
DP CD8 TIL
intravenous infusion of T cell suspension
- BIOLOGICAL
-
DP CD8 TIL KD
intravenous infusion of T cell suspension
- BIOLOGICAL
-
Low dose IL-2
Low dose IL-2 delivered subcutaneously for 1, 2 or 3 weeks
Sponsors & Collaborators
-
Phio Pharmaceuticals Inc.
collaborator INDUSTRY -
Providence St Joseph Health
collaborator UNKNOWN -
AgonOx, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-19
- Primary Completion
- 2026-12-31
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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