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

NCT07741877 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-03

No results posted yet for this study

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)

Interventions

BIOLOGICAL

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).

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2033-09-01
Completion
2034-09-01
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741877 on ClinicalTrials.gov