NCT04032847

ATL001 in Patients With Advanced Unresectable or Metastatic NSCLC

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Advanced Non-Small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Achilles Therapeutics UK Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC).

Detailed description

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterise the safety and clinical activity of autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with advanced non-small cell lung cancer (NSCLC). Patients will initially enter the study for procurement of tumour materials required to manufacture ATL001. Following manufacture of ATL001, the product will be given back to eligible patients following lymphodepletion. Patients will continue to be followed up for a minimum of 5 years, as part of a separate Long Term Follow Up Protocol, or, if the separate protocol is not available at the study site, within this protocol.

Conditions

• Advanced Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	ATL001	ATL001 infusion
DRUG	Pembrolizumab	Checkpoint inhibitor

Timeline

• Start date: 2019-07-08
• Primary completion: 2024-09-26
• Completion: 2024-09-26
• First posted: 2019-07-25
• Last updated: 2025-03-10
• Results posted: 2025-03-10

Locations

19 sites across 5 countries: United States, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study