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Experimental immune cell therapy targets Hard-to-Treat cancers

NCT ID NCT05397093

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tested a personalized cell therapy called ITIL-306 in people with advanced ovarian, lung, or kidney cancers that had not responded to standard treatments. The therapy uses a patient's own immune cells (TILs) taken from their tumor, modified to better attack cancer cells, and then infused back after a short course of chemotherapy. The study was terminated early after enrolling only one participant, so its safety and effectiveness remain unknown.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ITIL-306 (a cell therapy made from the patient's own tumor-infiltrating lymphocytes, engineered to target FOLR1 on tumors)
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This was a very early phase 1 trial with only 1 participant, and it was terminated early. The approach is complex and involves chemotherapy before the cell infusion, which carries risks like infection and organ damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1 person

The number who actually took part.

Started

Aug 2022

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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