ITIL-306 in Advanced Solid Tumors
ITIL-306-201 is a phase 1a/1b, multicenter, clinical trial evaluating the safety and feasibility of ITIL-306 in adult participants with advanced solid tumors whose disease has progressed after standard therapy. ITIL-306 is a cell therapy derived from a participant's own tumor-infiltrating immune cells (lymphocytes; TILs) and contains a unique molecule designed to increase TIL activity when it encounters folate receptor α (FOLR1) on the tumor.
Checked against the public recordLast updated Apr 15, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Instil Bio
- Interventions being studied
- Biological: ITIL-306
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Histologically documented advanced (metastatic and/or unresectable) disease as appropriate per cohort. * Phase 1a Dose Escalation: High-grade serous epithelial carcinoma of the ovary, fallopian tube, or peritoneum, adenocarcinoma of the lung, or clear-cell renal cell carcinoma. * Phase 1b Expansion: * Cohort 1: High grade serous, endometrioid, or clear cell epithelial carcinoma of the ovary, fallopian tube, or peritoneum. * Cohort 2: Squamous-cell carcinoma or adenocarcinoma of the lung. * Cohort 3: Clear cell or papillary RCC. * Disease must have unequivocally progressed during or after at least 1 prior line of systemic therapy that must include the following parameters (by indication): * Phase 1a dose escalation and Phase 1b Cohort 1: Participants with EOC whose disease has progressed during or after 1 prior line (at least 4 cycles) of platinum-based chemotherapy and had disease progression within 6 months from the last dose of the platinum agent. Participants who received 2 or more lines of platinum therapy must have disease which has progressed on or within 6 months after the date of the last dose of the platinum agent. Participants with BRCA-mutated EOC must have received previous PARP inhibitor therapy. * Phase 1a dose escalation and Phase 1b Cohort 2: Participants with NSCLC whose disease has progressed after 1 prior line of platinum-based doublet chemotherapy and a CPI. Participants with targetable mutations (e.g. EGFR/ALK/KRAS) are required to have progressed on targeted therapy in addition to a platinum-based doublet chemotherapy * Phase 1a dose escalation and Phase 1b Cohort 3: Participants with RCC whose disease has progressed after 1 prior line of antiangiogenic therapy and a PD-1-axis inhibitor. * 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 * Phase 1a: * EOC of the following subtypes: low-grade, endometrioid, clear cell, mucinous, sarcomatous, or mixed. * NSCLC of the following subtypes: squamous, neuroendocrine differentiation. * RCC of the following subtypes: nonclear-cell RCC * Phase 1b: * Cohort 1: Participants with mucinous, sarcomatous, and low-grade EOC. * Cohort 2: Participants with small cell lung cancer, or NSCLC with neuroendocrine differentiation * Cohort 3: Participants with nonclear-cell RCC, except papillary RCC * 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, dimethyl sulfoxide (DMSO), human serum albumin (HAS), phosphate buffer or gentamycin
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Washington University School of MedicineSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 15, 2026. Always confirm current availability with the study team.