NCT06151847

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

Reduced Dose Fludarabine/Cyclophosphamide Lymphodepletion Before Tumor-Infiltrating Lymphocyte Therapy With Lifileucel in Metastatic Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. The percentage of total TIL clones as measured by the T-cell receptor (TCR) population shared between the tumor infiltrating lymphocyte (TIL) product and peripheral blood mononuclear cells (PBMC). SECONDARY OBJECTIVES: I. To evaluate the efficacy parameters of lifileucel (LN-144) in combination with a reduced dose lymphodepletion in patients with unresectable or metastatic melanoma by assessing objective response rate (ORR), progression-free survival (PFS), and overall survival (OS). II. To characterize the safety profile of lifileucel (LN-144) in combination with a reduced dose lymphodepletion regimen in patients with unresectable or metastatic melanoma. EXPLORATORY OBJECTIVE: I. Blood and tumor samples will be banked for future correlative analyses, including flow cytometry, next generation sequencing, immunogenomics and RNA sequencing to characterize the immunome and microenvironment. OUTLINE: Patients undergo tumor resection surgery. After the lifileucel is manufactured (approximately 4 weeks later), patients receive cyclophosphamide intravenously (IV) on days -4 to -2 and fludarabine IV on days -4 to -1. Patients then receive lifileucel IV on day 0. Patients also receive up to 6 doses of intraleukin-2 IV. After completion of study treatment, patients are followed up at day 28, 42, 84, 126, 180, 365, month 18, and month 24.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-12-21
• Primary completion: 2025-11-27
• Completion: 2025-11-27
• First posted: 2023-11-30
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study