RecruitingPhase 2NCT07288073

TIL Therapy in cSCC and MCC

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


Sponsor

Karam Khaddour, MD, MS

Enrollment

14 participants

Start Date

Feb 10, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing tumor-infiltrating lymphocyte (TIL) therapy — a treatment where immune cells are taken from your tumor, multiplied in a lab, and infused back into your body to fight the cancer — for two types of skin cancer: cutaneous squamous cell carcinoma (cSCC) and Merkel cell carcinoma (MCC). **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of cSCC or MCC that cannot be surgically removed or has returned or spread - You have measurable disease visible on imaging - You are willing to undergo the intensive treatment process (including cell collection, chemotherapy conditioning, and infusion) **You may NOT be eligible if...** - Your cancer can still be surgically removed - You are not able to tolerate intensive supportive medical care - You have significant organ dysfunction - You are not willing to consent to the intensive nature of the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLN-145

Autologous tumor-infiltrating lymphocytes via intravenous (into the vein) infusion per protocol

DRUGCyclophosphamide

Antineoplastic drug, multi-dose vial, per institutional standards

DRUGFludarabine

Nucleotide metabolic inhibitor, single-use vial, via intravenous infusion per institutional standards

BIOLOGICALInterleukin-2

Recombinant, human glycoprotein, single-use vial, via intravenous infusion per protocol


Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT07288073


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