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CAR T-cell Therapy

ITIL-306 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Instil Bio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Medically suitable for surgical resection of tumor tissue

Cohort 2: Squamous-cell carcinoma or adenocarcinoma of the lung.

Must not have

Previously received TIL or engineered cell therapy (eg, CAR T-cell)

Symptomatic and/or untreated CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cell therapy for adults with solid tumors that have progressed after standard therapy. The therapy is derived from the patient's own tumor-infiltrating immune cells and is designed to increase activity against the tumor when it encounters a specific molecule on the tumor.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects aren't specified here but may include typical reactions related to cell therapies such as fever, fatigue, infusion-related reactions, and possible autoimmune responses due to increased immune activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am medically fit for surgery to remove my tumor.

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

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My cancer has spread and/or cannot be removed by surgery.

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I have high-grade serous carcinoma, lung adenocarcinoma, or clear-cell renal carcinoma.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer is advanced and cannot be removed by surgery.

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After tumor removal for TIL harvest, I still have at least one tumor that can be measured by CT or MRI.

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My kidney cancer worsened after 1 treatment for blood vessel growth and 1 PD-1 inhibitor.

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I have a specific type of ovarian, fallopian tube, or peritoneal cancer.

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My kidney cancer is either clear cell or papillary type.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I have a serious heart condition.

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I have had a stem cell transplant or organ transplant from a donor.

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I have a history of a serious brain or nerve condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Duration of response (DOR)

Objective response rate (ORR)

Overall Survival (OS)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 16Eligibility criteria met