A Feasibility Study of Tumor Infiltrating Lymphocytes in Cutaneous Squamous Cell Carcinoma and Merkel Cell Carcinoma
Karam Khaddour, MD, MS
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)
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Provide written informed consent, which includes understanding that there may be a need for intensive supportive care measures during the study and assessing willingness to undergo such measures, and written authorization for use and disclosure of protected health information. * Patients must be ≥ than 18 years of age at the time of signing the informed consent form. * Patients must have histologically or pathologically confirmed diagnosis of CSCC or MCC. Note: Mixed histology is allowed. Note: Neuroendocrine cancer that is clinically considered to be related to a cutane…
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
Location
- Dana-Farber Cancer InstituteBoston, Massachusetts