ITIL-168 in Advanced Melanoma

Trial ID or NCT#

NCT05050006

Status

not recruiting iconNOT RECRUITING

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).

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.
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Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy
Medical oncologist, Cutaneous oncology specialist
Clinical Associate Professor, Medicine - Oncology

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Contact

Phuong Pham
650-725-9810

View on ClinicalTrials.gov