ITIL-168 in Advanced Melanoma

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Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05050006
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Instil Bio
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Instil Study Director
Principal Investigator Affiliation	Instil Bio, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Canada, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Advanced Cutaneous Melanoma

Arms & Interventions

Arms

Experimental: Cohort 1

Patients who relapsed after or were refractory to at least 1 prior line of systemic therapy including a PD-1 inhibitor.

Experimental: Cohort 2

Patients who were intolerant to a PD-1 inhibitor and have persistent disease after stopping PD-1 therapy.

Experimental: Cohort 3

Patients who had a best response of stable disease despite being treated with at least 4 doses of a PD-1 inhibitor in the previous line of therapy.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

La Jolla, California

Status

Recruiting

Address

University of California San Diego, Moores Cancer Center

La Jolla, California, 92093

Site Contact

Mika Kaczmar

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