NCT03997474

ATL001 in Patients With Metastatic or Recurrent Melanoma

An Open-Label, Multi-Centre Phase I/IIa Study Evaluating the Safety and Clinical Activity of Neoantigen Reactive T Cells in Patients With Metastatic or Recurrent Melanoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (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 characterize the safety and clinical activity of ATL001, autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma.

Detailed description

This is a first-in-human, open-label, multi-centre, phase I/IIa study to characterize the safety and clinical activity autologous clonal neoantigen reactive T cells (cNeT) administered intravenously in adults with metastatic or recurrent melanoma. 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 be followed up for a period of 24 months post ATL001 infusion in the study. 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

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	ATL001	ATL001 infusion
DRUG	Checkpoint Inhibitor	Nivolumab

Timeline

• Start date: 2019-08-15
• Primary completion: 2024-09-03
• Completion: 2024-09-03
• First posted: 2019-06-25
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

10 sites across 2 countries: Spain, United Kingdom

Regulatory

• FDA-regulated drug study