Melanoma Clinical Trial
ITIL-168 in Advanced Melanoma
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).
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.
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There are 22 Locations for this study
La Jolla California, 92093, United States
Los Angeles California, 90025, United States
Los Angeles California, 90033, United States
Los Angeles California, 90095, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Washington District of Columbia, 20007, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Tampa Florida, 33612, United States
Chicago Illinois, 60612, United States
Maywood Illinois, 60153, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02215, United States
Minneapolis Minnesota, 55455, United States
Morristown New Jersey, 07962, United States
Cleveland Ohio, 44195, United States
Bethlehem Pennsylvania, 18015, United States
Philadelphia Pennsylvania, 19111, United States
Toronto Ontario, M5G 2, Canada
Cambridge England, CB2 0, United Kingdom
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