Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT06151847
Phase
PHASE2
Status
Completed

Conditions

  • Clinical Stage IV Cutaneous Melanoma AJCC v8
  • Metastatic Melanoma
  • Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
  • Unresectable Melanoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography — PROCEDURE
    Undergo echocardiography
  • Fludarabine — DRUG
    Given IV
  • Interleukin-2 — BIOLOGICAL
    Given IV
  • Lifileucel — BIOLOGICAL
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA scan
  • Tumor Resection — PROCEDURE
    Undergo tumor resection

Study Details

This phase II trial tests how well lifileucel, with reduce dose fludarabine and cyclophosphamide for lymphodepletion and interleukin-2, work for treating patients with melanoma that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).Lifileucel is made up of specialized immune cells called lymphocytes or T cells that are taken from a patient's tumor, grown in a manufacturing facility and infused back into the preconditioned patient to attack the tumor. Giving Lifileucel with a reduced dose of fludarabine and cyclophosphamide for lymphodepletion and interleukin -2 is being studied in patients with unresectable or metastatic melanoma.

Key Dates

Start date
Dec 21, 2023
Status verified
Apr 2026
Primary completion
Jul 10, 2025
Completion
Jul 10, 2025

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Lifileucel)
    Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy. A tumor sample is resected from each patient for lifileucel manufacturing. Patients then receive the lifileucel regimen which consists of a reduced dose non-myeloablative lymphodepletion, lifileucel infusion followed by interleukin-2.

Primary Outcome Measure

Percentage of total T-cell receptor (TCR) populations shared between the TIL product and peripheral blood mononuclear cells (PBMCs) [ Time Frame: At day + 42 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160-

Find similar trials in Kansas City, KS

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Kansas Cancer Center· Kansas City, KS

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