NCT04812470

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.

Conditions

• Metastatic Uveal Melanoma
• Metastatic Cutaneous Melanoma

Interventions

Type	Name	Description
DRUG	Autologous Tumor Infiltrating Lymphocytes	Administered via hepatic arterial infusion
DRUG	Melphalan	Melphalan will be administered once as an intravenous infusion.
DRUG	Interleukin-2	After TIL infusion, Interleukin-2 will be administered subcutaneously once daily for up to 14 days.

Timeline

• Start date: 2023-02-06
• Primary completion: 2025-05-26
• Completion: 2025-05-26
• First posted: 2021-03-23
• Last updated: 2025-09-22

Locations

1 site across 1 country: Sweden