TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant s
| Condition(s) | Lung Cancer, Lung Cancer Metastatic, Lung Cancer, Non-small Cell, Lung Cancer Recurrent |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoi |
| Who can participate | Inclusion Criteria: * Age: 16 years to 90 years * Histologically diagnosed as primary/relapsed/metastasized Lung cancer * Expected life span more than 3 months * Karnofsky≥60% or ECOG score 0-2 * Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. * Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated * At least 1 evaluable tumor lesion * Hematology and Chemistry（within 7 days prior to enrollment）: * Absolute count of white blood cells≥2.5×10\^9/L * Absolute count of neutropils≥1.5×10\^9/L * Absolute count of lymphocytes ≥0.7×109/L * Platelet count≥100×10\^9 * hemoglobin≥90 g/L * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant |
| Ages | 16 Years to 90 Years |
| Sex | All |
| Lead sponsor | Essen Biotech |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-08-20 |
| NCT ID | NCT06538012 |
| Official listing | https://clinicaltrials.gov/study/NCT06538012 |