Recruiting
Phase 2

Lifileucel

Sponsor:

Iovance Biotherapeutics, Inc.

Code:

NCT07741877

Conditions

Sarcoma

Soft Tissue Sarcoma (STS)

Advanced Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma (UPS)

Dedifferentiated Liposarcoma (DDLPS)

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

Lifileucel

Study Details

Brief summary:

A study of lifileucel (tumor-infiltrating lymphocytes) in adults with advanced soft tissue sarcoma ('SARATOGA')

Conditions

Sarcoma

Soft Tissue Sarcoma (STS)

Advanced Soft Tissue Sarcoma

Undifferentiated Pleomorphic Sarcoma (UPS)

Dedifferentiated Liposarcoma (DDLPS)

Study ID

NCT07741877

Start date

Oct 2, 2026

Status verified date

Oct, 2026

Completion date

Sep 1, 2034

Anticipated

Primary completion date

Sep 1, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lifileucel

Interventions

Lifileucel

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).

Primary outcome measure

  • Objective Response Rate [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Iovance Biotherapeutics Study Team

844-845-4682Clinical.Inquiries@iovance.com

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

More Information

Sponsor

Iovance Biotherapeutics, Inc.

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • TIL
  • Tumor Infiltrating Lymphocytes
  • Cell Therapy
  • Cellular Immuno-therapy
  • IL2
  • Lifileucel
  • Sarcoma
  • Soft Tissue Sarcoma
  • Advanced Soft Tissue Sarcoma
  • LN-145
  • Non-myeloablative lymphodepletion (NMALD)
  • SARATOGA
  • Undifferentiated pleomorphic sarcoma (UPS)
  • Dedifferentiated liposarcoma (DDLPS)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Iovance Biotherapeutics, Inc. on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.