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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Duration of response (DOR)
Objective response rate (ORR)
Overall Survival (OS)
+1 more

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.

Find a Location

Who is running the clinical trial?

Instil BioLead Sponsor
2 Previous Clinical Trials
29 Total Patients Enrolled
Instil Study DirectorStudy DirectorInstil Bio, Inc.
2 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

ITIL-306 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05397093 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Phase 1a: Dose Escalation, Phase 1b: Expansion
Non-Small Cell Lung Cancer Clinical Trial 2023: ITIL-306 Highlights & Side Effects. Trial Name: NCT05397093 — Phase 1
ITIL-306 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05397093 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers being considered for enrollment in this clinical trial?

"Clinicaltrials.gov indicates that the trial is presently searching for participants; this venture was initially advertised on August 24th 2022, and was recently updated October 20th 2022."

Answered by AI

Has ITIL-306 earned authorization from the FDA?

"As this is a Phase 1 trial, with minimal evidence to support ITIL-306's safety and efficacy, our team at Power gave it a score of 1."

Answered by AI

How many participants are currently enrolled in this research?

"Affirmative. The data displayed on clinicaltrials.gov attests that this investigation, which was initially announced on August 24th 2022, is actively seeking participants. Currently they are looking to enrol 51 patients between two medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
ITIL-306 in Advanced Solid Tumors
2022. "ITIL-306 in Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05397093.
~21 spots leftby Jul 2025
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