OncoMatch/Clinical Trials/NCT07288073
TIL Therapy in cSCC and MCC
Is NCT07288073 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including LN-145 and Interleukin-2 for cutaneous squamous cell carcinoma.
Treatment: LN-145 · Cyclophosphamide · Fludarabine · Interleukin-2 — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-PD-1 therapy — palliative
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
Lab requirements
Blood counts
ANC ≥ 1000/mm3; Hemoglobin ≥ 8.0 g/dL and not received transfusion of packed red blood cells within 7 days; Platelet count ≥ 100,000/mm3
Kidney function
Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using Cockcroft-Gault formula
Liver function
ALT and AST ≤ 3x ULN; for patients with liver metastases ≤ 5x ULN. Total bilirubin ≤ 2 mg/dL; patients with Gilbert's Syndrome ≤ 3 mg/dL.
Cardiac function
LVEF ≥ 45% and NYHA Class 1 or 2. Cardiac stress test required for significant ischemic heart disease or unstable arrhythmias; must demonstrate no irreversible wall movement abnormality. Patients with abnormal stress test may enroll if adequate ejection fraction and cardiology clearance.
Patients must have the following hematologic parameters: Absolute neutrophil count (ANC) ≥ 1000/mm3; Hemoglobin ≥ 8.0 g/dL and have not received transfusion of packed red blood cells within 7 days; Platelet count ≥ 100,000/mm3. Patients must have an adequate organ function with the following laboratory test values: Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN); and for patients with liver metastases ≤ to 5 times ULN. Total bilirubin ≤ 2 mg/dL; patients with Gilbert's Syndrome ≤ to 3 mg/dL. Estimated creatinine clearance (eCrCl) ≥ 40 mL/min using the Cockcroft-Gault formula at Screening. Patients must have a left ventricular ejection fraction (LVEF) ≥ 45% and be New York Heart Association (NYHA) Class 1 or 2. A cardiac stress test is required for patients who have significant ischemic heart disease, or clinically significant unstable arrythmias; the cardiac stress test must demonstrate no irreversible wall movement abnormality. Patients with an abnormal cardiac stress test may be enrolled if they have adequate ejection fraction and cardiology clearance.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify