ITIL-168 in Advanced Melanoma
Research type
Research Study
Full title
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)
IRAS ID
1003592
Contact name
Sophia Siu
Contact email
Sponsor organisation
Instil Bio
Eudract number
2020-003862-37
Clinicaltrials.gov Identifier
Research summary
Research 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 tumour-infiltrating immune cells (lymphocytes; TILs).
Summary of Results:
N/A – study terminated early prior to enrolling any UK patients. Study translational analysis is ongoing using data collected in the US.
A formal data analysis of the study which examined safety and efficacy has been completed, which includes all patients screened, enrolled, and treated before the trial was permanently discontinued. The toxicity profile of ITIL-168 was largely as expected, with most treatment-emergent adverse events attributable to the effects of lymphodepleting chemotherapy or high-dose IL-2. Objective responses were noted, including a complete response, in the patients dosed with ITIL-168.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0246
Date of REC Opinion
26 Nov 2021
REC opinion
Further Information Favourable Opinion