Clinical trial NCT05050006: ITIL-168 in Advanced Melanoma
Official 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Cutaneous Melanoma
Keywords: ITIL-168
Cell Therapy
melanoma
Autologous cell therapy
Cellular Immunotherapy
TIL
Autologous Adoptive Cell Transfer
Immuno-oncology
IL-2
Autologous Adoptive Cell Therapy
Tumor Infiltrating Lymphocytes
T-cell therapy
Lead sponsor: Instil Bio
Sponsor class: INDUSTRY
First posted: 2021-09-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All enrolled participants are assigned to be treated with a single dose of ITIL-168
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: Key Inclusion Criteria:

* Histologically confirmed advanced (unresectable or metastatic) cutaneous melanoma.
* Cohort 1: Disease that is relapsed after or refractory to at least 1 prior line of systemic therapy that must include a PD-1 inhibitor and, if positive for proto- oncogene BRAF V600 activating mutation, targeted therapy.
* Cohort 2: Disease that is persistent after discontinuing PD-1 due to toxicity. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
* Cohort 3: Disease that is stable (SD) after at least 4 doses of a PD-1 inhibitor. Patients with a proto-oncogene BRAF V600 activating mutation must have progressed after targeted therapy.
* Medically suitable for surgical resection of tumor tissue
* Following tumor resection for TIL harvest, will have, at minimum, 1 remaining measurable lesion as identified by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow and organ function

Key Exclusion Criteria:

* History of another primary malignancy within the previous 3 years
* Melanoma of uveal, acral, or mucosal origin
* Previously received an allogeneic stem cell transplant or organ allograft
* Previously received TIL or engineered cell therapy ( eg, CAR T-cell)
* Significant cardiac disease
* Stroke or transient ischemic attack within 12 months of enrollment
* History of significant central nervous system (CNS) disorder
* Symptomatic and/or untreated CNS metastases
* History of significant autoimmune disease within 2 years prior to enrollment
* Known history of severe, immediate hypersensitivity reaction attributed to cyclophosphamide, fludarabine, or IL-2.

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 60 months
Secondary outcomes:
measure: Duration of Response
timeFrame: Up to 60 months
measure: Progression-free Survival
timeFrame: Up to 60 months
measure: Overall Survival
timeFrame: Up to 60 months
measure: ORR as determined by investigators
timeFrame: Up to 60 months
measure: Frequency, duration, and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest
timeFrame: Up to 60 months
measure: Disease Control Rate
timeFrame: Up to 60 months
measure: Best Overall Response
timeFrame: Up to 60 months
measure: Time to Response
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego, Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic and Research Institute
state: California
city: Los Angeles
country: United States
facility: USC - Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA Health - Westwood Cancer Care
state: California
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Aurora
country: United States
facility: University of Colorado - Anschutz Cancer Pavilion
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Miami
country: United States
facility: The University of Miami - Sylvester Comprehensive Cancer Center
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Rush University Cancer Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville, James Graham Brown Cancer Center
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota, Masonic Cancer Center
state: Minnesota
city: Morristown
country: United States
facility: Atlantic Health System - Morristown Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic - Taussig Cancer Center
state: Ohio
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust - Addenbrooke's Hospital
state: England
Study officials:
affiliation: Instil Bio, Inc.
name: Instil Study Director
role: STUDY_DIRECTOR
References: