NCT04812470: HAITILS

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

Completed Phase 1 Last updated 22 September 2025

What this trial tests

Phase 1 trial testing Autologous Tumor Infiltrating Lymphocytes in Metastatic Uveal Melanoma in 8 participants. Completed in 26 May 2025.

Timeline

6 February 2023

Primary endpoint
26 May 2025

26 May 2025

Quick facts

Lead sponsor	Vastra Gotaland Region
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	6 February 2023
Primary completion	26 May 2025
Estimated completion	26 May 2025
Sites	1 location across Sweden

Drugs / interventions tested

• Autologous Tumor Infiltrating Lymphocytes — full drug profile →
• Melphalan (melphalan) — full drug profile →
• Interleukin-2

Conditions studied

• Metastatic Uveal Melanoma — all drugs for Metastatic Uveal Melanoma →
• Metastatic Cutaneous Melanoma — all drugs for Metastatic Cutaneous Melanoma →

Sponsor

Vastra Gotaland Region — full company profile →

Who can join

18 and older, any sex, with Metastatic Uveal Melanoma or Metastatic Cutaneous Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Tumor Infiltrating Lymphocyte (TIL) Therapy for Solid Tumor Treatment: Progressions and Challenges.
   Zhao Y, Deng J, Rao S, Guo S, et al · · 2022 · cited 114× · PMID 36077696 · DOI 10.3390/cancers14174160
2. Recent Advances and Challenges in Uveal Melanoma Immunotherapy.
   Fu Y, Xiao W, Mao Y. · · 2022 · cited 41× · PMID 35804863 · DOI 10.3390/cancers14133094
3. Recent clinical researches and technological development in TIL therapy.
   Matsueda S, Chen L, Li H, Yao H, et al · · 2024 · cited 23× · PMID 39264449 · DOI 10.1007/s00262-024-03793-4
4. Poor Response to Checkpoint Immunotherapy in Uveal Melanoma Highlights the Persistent Need for Innovative Regional Therapy Approaches to Manage Liver Metastases.
   Szeligo BM, Ivey AD, Boone BA. · · 2021 · cited 18× · PMID 34298647 · DOI 10.3390/cancers13143426
5. Therapeutic approaches to enhance natural killer cell cytotoxicity.
   Stenger TD, Miller JS. · · 2024 · cited 14× · PMID 38545115 · DOI 10.3389/fimmu.2024.1356666
6. TCR-Directed Therapy in the Treatment of Metastatic Uveal Melanoma.
   Strobel SB, Machiraju D, Hassel JC. · · 2022 · cited 11× · PMID 35267523 · DOI 10.3390/cancers14051215
7. Oncolytic Viruses and Immunotherapy for the Treatment of Uveal Melanoma and Retinoblastoma: The Current Landscape and Novel Advances.
   Kulbay M, Tuli N, Mazza M, Jaffer A, et al · · 2025 · cited 8× · PMID 39857692 · DOI 10.3390/biomedicines13010108
8. How we treat patients with metastatic uveal melanoma.
   Saldanha EF, Ribeiro MF, Hirsch I, Spreafico A, et al · · 2025 · cited 7× · PMID 40112696 · DOI 10.1016/j.esmoop.2025.104496