| NCT ID | NCT07288073 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Karam Khaddour, MD, MS |
| Condition | Cutaneous Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2028-09-29 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 cutaneous primary (MCC) or induced by sun damage (per investigator assessment) is allowed. * Patients must have unresectable, recurrent, or metastatic disease. * Patients must have a documented radiographic or clinical disease progression after treatment with ICI (including anti-PD-1 and anti-PD-L1) if it is used in the palliative setting. In patients who received ICI in the neoadjuvant or adjuvant setti