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

NCT07741877 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IOV-SAR-201
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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)

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)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  To evaluate the efficacy of lifileucel as measured by ORR per RECIST v1.1 as assessed by the IRC

  5 years

Secondary Outcomes (11)

• Complete Response Rate

  5 years

• Duration of Response

  5 years

• Disease Control Rate

  5 years

• Progression-Free Survival

  5 years

• Objective Response Rate

  5 years

Study Arms (1)

Lifileucel

EXPERIMENTAL

Biological: Lifileucel

Interventions

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).

Also known as: LN-145

Lifileucel

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

MeSH Terms

Conditions

Sarcoma; Histiocytoma, Malignant Fibrous; Liposarcoma

Interventions

lifileucel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Adipose Tissue

Central Study Contacts

Iovance Biotherapeutics Study Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): September 1, 2034
• Last Updated: August 3, 2026

Record last verified: 2026-07