ITIL-306 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Instil Bio

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with advanced solid tumors like ovarian, lung, or kidney cancer that got worse after standard treatment can join. They must be fit for surgery to remove tumor tissue and have good organ function. Specific criteria apply depending on the type of cancer and previous treatments received.

Inclusion Criteria

I am medically fit for surgery to remove my tumor.

My NSCLC worsened after platinum chemotherapy and CPI, and I've had targeted therapy if I have specific mutations.

My lung cancer is either squamous-cell carcinoma or adenocarcinoma.

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Exclusion Criteria

I have had TIL or CAR T-cell therapy before.

I have brain metastases that are either causing symptoms or have not been treated.

I have not had another cancer in the last 3 years.

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Treatment Details

Interventions

ITIL-306 (CAR T-cell Therapy)

Trial OverviewThe trial is testing ITIL-306, a cell therapy made from patients' own immune cells designed to target tumors expressing FOLR1. It's in early stages (phase 1a/1b) to see if it's safe and works as intended.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Phase 1b: ExpansionExperimental Treatment1 Intervention

Cohort 1: Participants with epithelial ovarian cancer (EOC) Cohort 2: Participants with non-small cell lung cancer (NSCLC) Cohort 3: Participants with renal cell carcinoma (RCC)

Group II: Phase 1a: Dose EscalationExperimental Treatment1 Intervention

Various doses will be tested in participants with EOC, NSCLC and RCC.