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Immune cell therapy takes on tough endometrial cancer

NCT ID NCT06481592

Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests a personalized cell therapy called lifileucel (TIL) in 60 people with advanced endometrial cancer that has been treated before. Doctors take a sample of the patient's tumor, grow immune cells from it in a lab, and then infuse them back after a short course of chemotherapy. The goal is to see if this approach can shrink tumors or stop them from growing.

What this could mean

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

Active substance
lifileucel (tumor-infiltrating lymphocytes, TIL)
What this could lead to
If it works, this could offer a new treatment option for advanced endometrial cancer that has not responded to prior therapies.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not apply to everyone. The treatment involves strong chemotherapy and IL-2, which can cause serious side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Nov 2029

An estimate. End dates often move.

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 to 70 years

Sex

Female participants only

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.

Inclusion Criteria: 1. Participants must have a histologically confirmed diagnosis of endometrial carcinoma. All histologies, including carcinosarcoma, will be allowed. Uterine sarcoma will not be allowed. 2. Participants who have received the following previous therapies: * At least 1 but no more than 4 lines of prior systemic therapy with no more than 2 lines of chemotherapy in any setting (ie, neoadjuvant or adjuvant setting as well as for recurrent, metastatic, or primary unresectable disease. . * Participants have received platinum-based chemotherapy and anti-PD-1/PD-L1 therapy. * Participants who declined platinum-based chemotherapy regimen and/or an anti-PD-1/PD-L1 therapy or were deemed ineligible for such therapies by the investigator may be considered after discussion with the medical monitor. * Systemic therapy counting towards lines of therapy includes chemotherapy, targeted therapy, immunotherapy, and antibody drug conjugates, given alone or in combination. Hormonal therapy does not count as a line of therapy. * Participants must have either (i) documented radiographic disease progression during or after the last line of therapy or (ii) discontinued their last line of therapy because of treatment intolerance or toxicity or (iii) with medical monitor discussion, participant/physician decision in the context of stable disease with evidence of tumor growth. 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and estimated life expectancy of \>6 months. 4. Participants having at least one resectable lesion and at least one measurable lesion, following resection of the lesion for TIL generation. 5. Participants who have adequate organ function, including adequate cardiopulmonary function. 6. Participants of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after the last dose of study intervention. 7. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. Exclusion Criteria: 1. Participants who have symptomatic untreated brain metastases. 2. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. 3. Participants who require systemic steroid therapy \> 10 mg/day prednisone or another steroid equivalent dose. 4. Participants who have any form of primary immunodeficiency. 5. Participants who have another primary malignancy within the previous 3 years. 6. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMALD.

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Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm

As listed by the trial registrant

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

Endometrial cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    12 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Allegheny Health

    RECRUITING

    Pittsburgh, Pennsylvania, 15524, United States

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Avera Medical Group Oncology

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Barbara Ann Karmanos Cancer Hospital

    RECRUITING

    Detroit, Michigan, 48201, United States

  • H. Lee Moffitt Cancer Center and Research Institute, Inc.

    RECRUITING

    Tampa, Florida, 33612, United States

  • Honor Health

    RECRUITING

    Phoenix, Arizona, 85016, United States

  • MD Anderson Cancer Center - U of Texas

    RECRUITING

    Houston, Texas, 77030, United States

  • Orlando Health

    RECRUITING

    Orlando, Florida, 32806, United States

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14203, United States

  • University of Oklahoma

    RECRUITING

    Oklahoma City, Oklahoma, 73117, United States

  • University of Southern California

    RECRUITING

    Los Angeles, California, 90007, United States

  • UofL Health - Brown Cancer Center

    RECRUITING

    Louisville, Kentucky, 40202, United States

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