MT2020-36: 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)
Protocol ITIL-168-101 is a phase 2, open-label, multicenter study evaluating the safety and efficacy of ITIL-168 in adult subjects with advanced melanoma who relapsed after or were refractory to at least 1 prior line of systemic therapy. Subjects will be assessed for study eligibility during the screening period, which occurs within 21 days after the signing of the informed consent form. Once a subject is deemed eligible to participate, they will undergo surgical resection of tumor tissue necessary to harvest TILs for the manufacturing of ITIL-168. Tumor resection should take place within 30 days after providing consent.
• 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
• 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.
Advanced Cutaneous Melanoma
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, Clinics and Surgery Center (CSC)