ITIL-168 in Advanced Solid Tumors

Recruitment & Eligibility

Inclusion Criteria

Histologically documented advanced (metastatic and/or unresectable) cervical cancer, HNSCC, or NSCLC.
Cohort 1: Participants with cervical cancer whose disease progressed during or after at least 1 prior line of chemotherapy.
Cohort 2: Participants with HNSCC whose disease progressed during or after chemotherapy that must have included a platinum agent and previous CPI.
Cohort 3: Participants with NSCLC whose disease progressed during or after 1 prior line of platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have progressed on targeted therapy and platinum-based chemotherapy
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
Neuroendocrine carcinoma, nasopharyngeal carcinoma, squamous cell carcinoma of the lip, or histopathology with neuroendocrine differentiation
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, IL-2, of CPI

Study & Design

Arm && Interventions

Group	Intervention	Description
Cohort 1	ITIL-168	Participants with cervical cancer whose disease has progressed during or after treatment with platinum-based chemotherapy. Participants with combined positive score ≥ 1 should also have disease that has progressed during or after treatment with CPI.
Cohort 2	ITIL-168	Participants with head and neck squamous-cell carcinoma (HNSCC) whose disease has progressed during or after platinum-based chemotherapy and previous CPI.
Cohort 3	ITIL-168	Participants with non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK) are required to have disease which has progressed on targeted therapy and platinum-based chemotherapy.

Primary Outcome Measures

Name	Time	Method
Frequency and severity of ITIL-168 treatment-emergent adverse events (AEs), serious AEs, and AEs of special interest	Up to 24 months

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival	Up to 60 months	Progression-free survival (PFS) is defined as the time from the ITIL-168 infusion date to the date of disease progression or death from any cause.
Objective response rate	Up to 60 months	Objective response rate (ORR), defined as the incidence of a complete response (CR) or a partial response (PR) per a modified Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria, as assessed by investigator review.
Duration of response	Up to 60 months	For participants who experience an objective response, duration of response (DOR) is defined as the time from their first objective response to disease progression or death.
Overall Survival	Up to 60 months	Overall survival (OS) is defined as the time from the ITIL-168 infusion date to the date of death from any cause.

Recruitment & Eligibility