NCT06151847 - Lifileucel With Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion and Interleukin-2 for the Treatment of Patients With Unresectable or Metastatic Melanoma | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 21, 2023

Primary Completion Date

November 27, 2025

Study Completion Date

November 27, 2025

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic MelanomaPathologic Stage IIIC Cutaneous Melanoma AJCC v8Unresectable Melanoma

Interventions

PROCEDURE

Biospecimen Collection

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

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography

Undergo echocardiography

DRUG

Fludarabine

Given IV

BIOLOGICAL

Interleukin-2

Given IV

BIOLOGICAL

Lifileucel

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA scan

PROCEDURE

Tumor Resection

Undergo tumor resection

Trial Locations (1)

66160

RECRUITING

University of Kansas Cancer Center, Kansas City