NEO-PTC-01 in Patients With Advanced or Metastatic Melanoma
Status:
Recruiting
Trial end date:
2025-10-31
Target enrollment:
Participant gender:
Summary
Study to 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).
The dose-finding part of the study 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, a cohort to investigate
NEO-PTC-01 in combination with interleukin (IL)-2 and another cohort introducing α programmed
cell death protein 1 (αPD-1) therapy. The dose expansion part of the study will test the dose
deemed to be safe in the dose-finding part of the study in an expanded cohort of patients to
further define the safety of NEO-PTC-01.