Actively Recruiting
Phase I Study of Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte Therapy for Advanced Epithelial and Immune Checkpoint Blockade-resistant Solid Tumors
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-11-07
10
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying a new type of cancer treatment called NEXTGEN-TIL, which uses specially selected immune cells called tumor-infiltrating lymphocytes TILs taken from a patients own tumor. This early phase trial focuses on patients with metastatic or unresectable epithelial cancers and solid tumors that have not responded to immune checkpoint blockade therapies. The goal is to evaluate the safety and tolerability of this next-generation TIL therapy, as well as to explore its early effects on cancer in these patients. The treatment involves collecting TILs from the patients tumor and growing them in the lab to enhance their cancer-fighting ability. Before receiving the TIL infusion, patients undergo a preparative chemotherapy regimen called non-myeloablative lymphodepletion to help the infused cells expand. After the TIL therapy, patients receive injections of interleukin-2 IL-2 to support the immune cells. The TIL infusion is given intravenously on Day 0, following chemotherapy, and IL-2 is administered multiple times over the next few days. Patients are then followed for up to 2 years with regular assessments. Participants will have frequent visits during the first 9 months and additional check-ins up to 2 years to monitor treatment safety and effects. Researchers will collect data on adverse events, laboratory tests, heart function, vital signs, physical exams, and performance status. They will also study the characteristics of the infused TILs and measure cancer response and progression over time. This thorough monitoring helps ensure patient safety and gathers information on how well the therapy works.
CONDITIONS
Brief Title
Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors
Research Team
E
Elena Garralda
S
Susana Muñoz
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