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 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.