NCT03991741

Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

Phase I Trial of Lymphodepletion Followed by Adoptive Cell Transfer of Autologous Tumor Infiltrating Lymphocytes and High-Dose Interleukin 2 in Select Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Gregory Daniels · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells.

Detailed description

To determine whether special tumor fighting cells that is taken from participants' tumors and grown in the laboratory and then given back to the participant will fight the participant's cancer when their immune system is suppressed from attacking these special tumor fighting cells. This is called transfer of autologous (they came from you) tumor infiltrating lymphocytes (the cells that have been grown in the laboratory. Participants getting these cell infusions will also be treated with interleukin-2 (IL-2).

Conditions

• Metastatic Melanoma
• Locally Advanced Refractory/Recurrent Melanoma
• Metastatic Head and Neck Cancer
• Locally Advanced Refractory/Recurrent Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Tumor Infiltrating Lymphocytes	Autologous TILs
BIOLOGICAL	High-Dose Interleukin 2	720,000 IU/kg every 8 hours for up to 15 doses

Timeline

• Start date: 2020-10-07
• Primary completion: 2023-01-26
• Completion: 2023-01-26
• First posted: 2019-06-19
• Last updated: 2025-07-03
• Results posted: 2025-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study