NCT05050006

ITIL-168 in Advanced Melanoma

A Phase 2, Open-label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes (TILs) in Subjects With Advanced Melanoma (DELTA-1)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Instil Bio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).

Conditions

• Advanced Cutaneous Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ITIL-168	ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.

Timeline

• Start date: 2021-10-07
• Primary completion: 2023-02-27
• Completion: 2023-02-27
• First posted: 2021-09-20
• Last updated: 2024-04-16

Locations

22 sites across 3 countries: United States, Canada, United Kingdom

Regulatory

• FDA-regulated drug study