Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT07288073

TIL Therapy in cSCC and MCC

Led by Karam Khaddour, MD, MS · Updated on 2026-02-13

14

Participants Needed

1

Research Sites

176 weeks

Total Duration

On this page

Sponsors

K

Karam Khaddour, MD, MS

Lead Sponsor

I

Iovance Biotherapeutics, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

TIL Therapy in cSCC and MCC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provide written informed consent including authorization for use of protected health information.
  • Be 18 years of age or older at the time of consent.
  • Have a confirmed diagnosis of Cutaneous Squamous Cell Carcinoma (CSCC) or Merkel Cell Carcinoma (MCC), including mixed histology or related neuroendocrine cancer.
  • Have unresectable, recurrent, or metastatic disease.
  • Show documented disease progression after immune checkpoint inhibitor (ICI) treatment or recurrence within 6 months if ICI was given as neoadjuvant or adjuvant therapy.
  • Have an ECOG performance status of 0 to 2.
  • Have at least one resectable lesion with a minimum diameter of 1.5 cm for TIL production.
  • Have at least one measurable or evaluable lesion after tumor harvest.
  • Meet specified hematologic parameters: ANC ≥ 1000/mm3, hemoglobin ≥ 8.0 g/dL without recent transfusion, platelet count ≥ 100,000/mm3.
  • Have adequate organ function with ALT and AST ≤ 3 times ULN (or ≤ 5 times ULN with liver metastases), total bilirubin ≤ 2 mg/dL (or ≤ 3 mg/dL with Gilbert's Syndrome), and creatinine clearance ≥ 40 mL/min.
  • Have left ventricular ejection fraction ≥ 45% and be NYHA Class 1 or 2; cardiac stress test if needed.
  • Have adequate pulmonary function based on specified criteria.
  • Completed or discontinued systemic therapy at least 21 days before tumor harvest.
  • Recovered from prior treatment-related adverse events to Grade ≤ 1, with some exceptions.
  • Willing to use effective birth control during treatment and for 12 months after if of childbearing potential.
Not Eligible

You will not qualify if you...

  • History of allogenic organ transplant.
  • Symptomatic untreated brain metastases; some treated or stable brain metastases allowed with conditions.
  • Require systemic steroid therapy >10 mg/day prednisone or equivalent (replacement therapy allowed).
  • Active infections requiring systemic treatment.
  • Pregnant or breastfeeding; females must have negative pregnancy test.
  • Active medical illnesses posing increased risk, including systemic infections and major cardiovascular, respiratory, or immune system illnesses.
  • Received live or attenuated vaccine within 28 days before treatment start.
  • Primary immunodeficiency disorders or AIDS.
  • History of allogenic stem cell transplant or active hematologic malignancy.
  • Known hypersensitivity to study drugs or components of TIL product.
  • Another primary malignancy within the past year, with certain exceptions for low-risk cancers.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

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Research Team

K

Karam Khaddour, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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