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TIL Therapy in cSCC and MCC

NCT07288073 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-02-13

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    collaborator INDUSTRY

  • Karam Khaddour, MD, MS

    lead OTHER

Principal Investigators

  • Karam Khaddour, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2028-09-29
Completion
2029-06-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07288073 on ClinicalTrials.gov