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Can a Patient's own immune cells fight advanced sarcoma?

NCT ID NCT07741877

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether lifileucel, a therapy made from a patient's own tumor-infiltrating lymphocytes (immune cells), can shrink tumors in adults with advanced soft tissue sarcoma. Participants will have their tumor removed to create the personalized therapy, then receive a short course of chemotherapy followed by the lifileucel infusion and a brief course of aldesleukin. The study focuses on two types of sarcoma: undifferentiated pleomorphic sarcoma and dedifferentiated liposarcoma, and will measure how many patients respond to treatment.

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, also known as LN-145), given after a preparative chemotherapy regimen and followed by a short course of aldesleukin (interleukin-2)
What this could lead to
If successful, this could offer a new treatment option for people with advanced soft tissue sarcoma, potentially shrinking tumors and improving outcomes.
What could go wrong
This is a phase 2 trial, so the treatment may not work for everyone and could have significant side effects, including reactions to the chemotherapy and immune-related 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 80 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2034

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

16 to 70 years

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.

Inclusion Criteria: * Participant must be ≥ 16 years of age at the time of signing the informed consent and assent. * Participants who are \> 70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. * Participant must have a confirmed diagnosis of histologically confirmed unresectable or metastatic UPS (Cohort 1) or DDLPS (Cohort 2), with or without a well-differentiated component, who have received ≥ 1 and a maximum of 3 prior systemic therapies, including ≥ 1 anthracycline-based regimen. * Participant has demonstrated progressive disease on or after the last line of therapy. * Participant is assessed as having at least one resectable lesion (or aggregate lesions) with an estimated minimum diameter of 1.5 cm (short axis) for lifileucel generation. * Following tumor resection for lifileucel generation, the participant will have at least one measurable lesion, as defined by RECIST v1.1 at Baseline. * Participant is expected to achieve washout from investigational or anticancer therapy(ies). * If the participant has preplanned surgical procedure(s), the procedure will take place at least 14 days (for major operative procedures) prior to the tumor resection. Wound healing will have occurred, and all complications will have resolved at the time of tumor resection. * Participant has recovered from all prior anticancer treatment-related AEs to Grade ≤ 1(per NCI-CTCAE), except for peripheral neuropathy, alopecia, or vitiligo. * Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control. * Participants must have adequate organ function. * Participant is willing to receive optimal supportive care, including intensive care, from enrollment until the first post-treatment tumor assessment. Exclusion Criteria: * Participant has symptomatic untreated brain metastases. * The participant has an ECOG performance status of ≥ 2, a need for urgent therapy due to rapidly progressive disease or tumor mass effect, or an estimated life expectancy of\< 6 months. * Participant has an active medical illness(es) that, in the opinion of the investigator, would pose increased risks for study participation. * Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease \[SCID\] or AIDS). * Participant has a history of hypersensitivity to any component of the study intervention. * Participant had another primary malignancy within the previous 3 years (except for those that do not require treatment or have been curatively treated \> 1 year ago, and in the judgment of the investigator does not pose a significant risk of recurrence. Other protocol defined inclusion/exclusion criteria could apply.

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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.

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 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 ↗

  3. A doctor treating you

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Contacts and locations

Study contacts

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