NCT06961786

TNFα and IL-2 Coding Oncolytic Adenovirus TILT-123 With Lymphocyte-depleting Chemotherapy and TILs in the Treatment of Melanoma

A Phase 1, Open-label, Single-arm Study to Investigate the Safety, Tolerability, and Preliminary Efficacy of TNFa and IL-2 Coding Oncolytic Adenovirus TILT-123 in Combination With Lymphocyte-depleting Chemotherapy and Tumor-infiltrating Lymphocytes in Melanoma Patients.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: TILT Biotherapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, phase 1 trial evaluating the safety of oncolytic adenovirus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in metastatic melanoma patients.

Detailed description

TILT-123 is a tumor-selective replicating oncolytic adenovirus expressing TNFa and IL-2 that is being investigated in several Phase 1 clinical studies in patients with various types of cancer. This is the second study of TILT-123 in patients with metastatic melanoma. Building upon the previous study, TILT-T215, which evaluated the safety and preliminary efficacy of TILT-123 in combination with TILs, Study TILT-T216 will investigate the addition of lymphocyte-depleting chemotherapy to the combination of TILT-123 and TILs. The purpose of lymphodepleting chemotherapy, cyclophosphamide and fludarabine phosphate is to reduce irrelevant T cells and eliminate the regulatory T cells, which are known to be able to inhibit T-cell mediated tumor cell killing.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	TILT-123	TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
BIOLOGICAL	TIL	Adoptive T cell therapy with TILs
DRUG	Cyclophosphamide	Lymphocyte-depleting chemotherapy
DRUG	Fludarabine	Lymphocyte-depleting chemotherapy

Timeline

• Start date: 2025-06-25
• Primary completion: 2026-11-01
• Completion: 2027-04-01
• First posted: 2025-05-08
• Last updated: 2026-03-05

Locations

1 site across 1 country: Denmark