A Study of Lifileucel (Tumor-infiltrating Lymphocytes) in Adults With Advanced Soft Tissue Sarcoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age16 Years to 70 Years
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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.

You cannot join if

• 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

lifileucel. A preparation of autologous tumor infiltrating lymphocytes (TILs), with potential antineoplastic activity. TILs are isolated from a patient's tumor tissue, cultured in vitro with high-dose interleukin-2 (lL-2), further selected based on antigen specificity and tumor reactivity, and the selected TILs are subsequently expanded. Upon re-introduction of lifileucel into the patient, the TILs re-infiltrate the tumor, specifically recognize the tumor-associated antigens (TAAs), and initiate tumor cell lysis. IL-2 induces the proliferation and expansion of TILs in vitro. NCI Drug Dictionary

Treatments listed in the registry

• Lifileucel (Biological): Study intervention will begin with a tumor resection from which lifileucel will be generated. The lifileucel regimen consists of a preparative NMA-LD regimen (ie, cyclophosphamide with mesna followed by fludarabine), the lifileucel infusion, and an abbreviated course of aldesleukin (interleukin-2).

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• surgery: Part of the study plan

Main goals

• Objective Response Rate (5 years)

Other goals

• Complete Response Rate
• Duration of Response
• Disease Control Rate
• Progression-Free Survival
• Objective Response Rate
• Complete Response Rate
• Duration of Response
• Disease Control Rate
• Progression-Free Survival
• Overall Survival
• Adverse Events

Planned enrollment: 80 (estimated).

• Moffitt Cancer Center, Tampa, Florida
• Memorial Sloan Kettering Cancer Center, New York, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07741877
• NCI Drug Dictionary: C120552

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 8, 2026. Public record; not medical advice.