NCT06107894

TIL Therapy for Patients With Advanced Solid Tumors

Phase I Clinical Trial to Evaluate the Safety and Tolerability of NEOG-100 in Patients With Advanced Breast Cancer and Lung Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: NeogenTC · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study is a phase I clinical trial to investigate the safety and tolerability of NEOG-100 in patients with advanced breast cancer and lung cancer. NEOG-100, an autologous tumor infiltrating lymphocytes (TILs), is infused intravenously into the patient after non-myeloablative (NMA) lymphodepletion treatment.

Detailed description

Study treatment will begin with intravenous NMA lymphodepleiting regimen composed by cyclophosphamide and fludarabine, followed by infusion of NEOG-100. Cyclophosphamide will administered for two days and fludarabine for five days. Patients in Cohort 1 will receive NEOG-100 and patients in Cohort 2 will receive NEOG-100 plus low-dose (2 MIU) IL-2.

Conditions

• Advanced Breast Cancer
• Advanced Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Tumor-infiltrating lymphocytes	After NMA Lymphodepletion, autologous TILs will be intravenous infused into patients.
DRUG	IL-2	IL-2 will be subcutaneous administrated for 14 days following TILs infusion.

Timeline

• Start date: 2024-01-01
• Primary completion: 2025-09-01
• Completion: 2026-05-01
• First posted: 2023-10-30
• Last updated: 2023-10-30