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

Sponsor
Iovance Biotherapeutics, Inc.
Study ID
NCT07741877
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Soft Tissue Sarcoma
  • Dedifferentiated Liposarcoma (DDLPS)
  • Sarcoma
  • Soft Tissue Sarcoma (STS)
  • Undifferentiated Pleomorphic Sarcoma (UPS)

Eligibility Criteria

Sex
ALL
Age
16 Years - 70 Years
Healthy Volunteers
Not accepted

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).

Study Details

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

Key Dates

First listed
Aug 3, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 1, 2033
Completion
Sep 1, 2034

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lifileucel

Primary Outcome Measure

Objective Response Rate [ Time Frame: 5 years ]

Central Contacts

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