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

Phase 1 Completed 8 enrolled Vastra Gotaland Region Miltenyi Biomedicine GmbH · collab

NaSequentialOpen-labelTreatment

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.

Timeline

Start: 2023-02-06
Primary completion: 2025-05-26
Completion: 2025-05-26

Publications

Nelson A, Riise R, Alsen S, Wong A, Carlson P, Edman S, Holgersson J, Olofsson Bagge R, Johansson I, Sadik M, Edenbrandt L, Nilsson LM, Nilsson JA, Ny L. Phase I trial of locoregional administration of autologous tumor-infiltrating lymphocytes in patients with uveal melanoma and liver metastases (the HAITILS trial). J Immunother Cancer. 2026 Mar 18;14(3):e014401. doi: 10.1136/jitc-2025-014401.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Autologous Tumor Infiltrating Lymphocytes	Cell therapy	1e+08 cells	Other
Subject	Autologous Tumor Infiltrating Lymphocytes	Cell therapy	3e+08 cells	Other
Subject	Autologous Tumor Infiltrating Lymphocytes	Cell therapy	1e+09 cells	Other
Background	Melphalan	Small molecule	1 mg/kg	Intravenous
Background	aldesleukin	Protein / enzyme biologic	2e+06 iu	Subcutaneous

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

Summary

Timeline

Publications

Drugs

Indications