NCT04625205

A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma

An Open-label, Phase I Study of NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: BioNTech US Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the safety and activity of NEO-PTC-01 in patients with unresectable or metastatic melanoma. NEO-PTC-01 is an autologous personalized T cell (PTC) product for adoptive cell therapy that is manufactured ex vivo and targets neoantigens displayed on the patient's tumor and the tumor microenvironment. The study will be conducted in two parts, Part 1 (Dose Finding) and Part 2 (Dose Expansion).

Detailed description

Part 1 will test two doses of NEO-PTC-01 and will be structured according to a 3+3 dose escalation design. After the highest tolerated NEO-PTC-01 dose is identified, 2 additional evaluations in Part 1 are planned to investigate the combination of NEO-PTC-01 with either interleukin (IL) 2-directed or programmed cell death protein 1 (PD-1) inhibitor therapy, respectively. Part 2 will test the dose deemed to be safe in the dose-finding part of the study to further define the safety of NEO-PTC-01 in patients currently receiving PD-1/ programmed death ligand 1 (PD-L1) inhibitors (as single agent or in combination with cytotoxic T-lymphocyte-associated antigen-4 \[CTLA4\] inhibitors) as first line therapy for metastatic melanoma. Patients who were treated on previous protocol versions and left the study due to disease progression or who have completed the 52-week follow-up period, may re-enter the study for an extended 5-year follow up in which additional assessments will be conducted.

Conditions

• Unresectable Melanoma
• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	NEO-PTC-01	Administered via intravenous infusion.
DRUG	IL-2	Administered via intravenous infusion.
DRUG	PD-1 Inhibitors	Administered via intravenous infusion.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-03-26
• Completion: 2025-03-26
• First posted: 2020-11-12
• Last updated: 2025-04-06

Locations

2 sites across 2 countries: Belgium, Netherlands