Can a Patient's own immune cells fight advanced sarcoma?
NCT ID NCT07741877
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2034
An estimate. End dates often move.
- Lead sponsor
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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
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16 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Triple attack on aggressive sarcoma: can radiation, immunotherapy, and chemo shrink tumors before surgery?
- Can an oral drug that starves tumors help Hard-to-Treat cancers?
- Can a Dual-Target drug crack resistant gynecologic and breast cancers?
- Can a new drug shrink advanced solid tumors?
- Can a new drug boost chemotherapy against rare sarcomas?