NCT05676749

C-TIL051 in Non-Small Cell Lung Cancer

C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: AbelZeta Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer. The purpose of this study is to: 1. Test the safety and ability for subjects to tolerate the TIL therapy 2. Measure to see how the NSCLC responds to the TIL therapy Participants will be asked to: * Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051. * Receive standard of care treatment until their lung cancer no longer responds * When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site * Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest * C-TIL051 will then be infused on day 0 followed by NKTR-255 (IL-15) about 12 to 24 hours later * Pembrolizumab will be administered every 3 weeks for up to 2 years NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8+ T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response. The combination of NKTR 255 and TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity.

Conditions

• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	C-TIL051	C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2023-01-09
• Last updated: 2026-01-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study