NCT07288073

TIL Therapy in cSCC and MCC

A Feasibility Study of Tumor Infiltrating Lymphocytes in Cutaneous Squamous Cell Carcinoma and Merkel Cell Carcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Karam Khaddour, MD, MS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to test the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy. The names of the study interventions involved in this study are: * Tumor Infiltrating Lymphocytes (a type of cellular therapy) * Fludarabine and Cyclophosphamide (types of standard of care chemotherapy drugs) * Interleukin-2 (a type of recombinant, human glycoprotein)

Detailed description

This is an open-label, multi-cohort, non-randomized, single-center, phase 2 clinical trial testing the safety and effectiveness of a tumor-infiltrating lymphocyte (TIL) cellular therapy, also called LN-145 or lifileucel, and chemotherapy in combination with Interleukin-2 (IL-2) to find out what effects, if any, the combination has on participants with Cutaneous squamous cell carcinoma (CSCC) or Merkel Cell Carcinoma (MCC) who were previously treated with immunotherapy. Lymphocytes are a part of the immune system that help fight infection and prevent and fight cancers. TIL cells are grown in a specialized laboratory with the goal of making more of them so that the TIL cells better recognize and kill cancer cells when administered again into the body. The U.S. Food and Drug Administration (FDA) has approved Fludarabine and Cyclophosphamide as standard-of-care lymphodepleting chemotherapy medications. The U.S. FDA has not approved TIL therapy, Lifileucel plus IL-2, for CSCC or MCC, but it has been approved for the treatment of another type of skin cancer, advanced melanoma. The research study procedures include screening for eligibility, in-clinic visits, blood tests, urine tests, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, or Positron Emission (PET) scans, X-rays, electrocardiograms (ECGs), echocardiograms (ECHOs), Cardiac stress test, lung function test, bone marrow biopsies and aspirations. It is expected that about 14 people will take part in this research study. Iovance Biotherapeutics, Inc. is supporting this research study by providing the study therapy, IL-2 and funding.

Conditions

• Cutaneous Squamous Cell Carcinoma
• Merkel Cell Carcinoma
• Metastatic Cutaneous Squamous Cell Carcinoma
• Skin Cancer

Interventions

Type	Name	Description
BIOLOGICAL	LN-145	Autologous tumor-infiltrating lymphocytes via intravenous (into the vein) infusion per protocol
DRUG	Cyclophosphamide	Antineoplastic drug, multi-dose vial, per institutional standards
DRUG	Fludarabine	Nucleotide metabolic inhibitor, single-use vial, via intravenous infusion per institutional standards
BIOLOGICAL	Interleukin-2	Recombinant, human glycoprotein, single-use vial, via intravenous infusion per protocol

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-09-29
• Completion: 2029-06-29
• First posted: 2025-12-17
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study