NCT06455917

TIL Therapy in Non-small-cell Lung Cancer (NSCLC) Patients

A Phase II Trial of Adoptive Cell Therapy With Tumor-infiltrating Lymphocytes in Patients With Non-Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to investigate the efficacy and safety of adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL) in patients with advanced pre-treated non-small cell lung cancer (NSCLC).

Detailed description

Adoptive cell therapy (ACT) with tumor-infiltrating lymphocytes (TIL) is a personalized immunotherapy. TIL-ACT involves the infusion of autologous CD4+ and CD8+ T lymphocytes collected from tumor material and expanded ex-vivo with IL-2. These polyclonal immune cells can recognize and target multiple individualized tumor-specific antigens. Clinical trials have demonstrated significant response rates in advanced melanoma patients. However, few trials have investigated TIL-ACT in other solid tumors, including NSCLC. For NSCLC patients experiencing disease progression after standard therapies (immune checkpoint inhibitors, targeted therapies), effective options are limited, often restricted to traditional chemotherapy with modest response rates, short durability, and significant toxicity. TIL-ACT represents an attractive individualized treatment approach for NSCLC patients. The BaseTIL-02L study is a single-arm phase II trial investigating TIL-ACT efficacy in pretreated NSCLC patients. The study protocol includes preconditioning non-myeloablative chemotherapy (cyclophosphamide and fludarabine) and in-vivo TIL activation with high-dose interleukin 2 (for up to 15 doses, every 8 hours) following TIL transfer.

Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	TILs（Tumor Infiltrating Lymphocytes）	The study procedures are: * Tumor collection: Study-specific intervention (eg, surgical resection and/or biopsy) to collect tumor material from one or more tumor lesions/metastases for the generation of the TIL product (tumor-infiltrating lymphocytes, TILs). * TIL expansion: Production of the TIL product in the Good-Manufacturing-Practice (GMP) Facility for Advanced Therapies of the University Hospital of Basel. * Lymphodepleting chemotherapy (lymphodepletion): Chemotherapy with cyclophosphamide and fludarabine (day -7 until day -3). * TIL transfer: Infusion of the TIL product back to the patient. TIL transfer is scheduled on day 0. * Interleukin-2 (IL-2) therapy: Therapy with high-dose IL-2 (Aldesleukin) every 8 hours for up to 15 doses. IL-2 therapy starts on day 0.

Timeline

• Start date: 2025-01-22
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2024-06-12
• Last updated: 2025-11-19

Locations

1 site across 1 country: Switzerland