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

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).

Timeline

Start

2020-12-01

Primary completion

2025-03-26

Completion

2025-03-26

Publications

• Borgers JSW, Lenkala D, Kohler V, Jackson EK, Linssen MD, Hymson S, McCarthy B, O'Reilly Cosgrove E, Balogh KN, Esaulova E, Starr K, Ware Y, Klobuch S, Sciuto T, Chen X, Mahimkar G, Sheen JHF, Ramesh S, Wilgenhof S, van Thienen JV, Scheiner KC, Jedema I, Rooney M, Dong JZ, Srouji JR, Juneja VR, Arieta CM, Nuijen B, Gottstein C, Finney OC, Manson K, Nijenhuis CM, Gaynor RB, DeMario M, Haanen JB, van Buuren MM. Personalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial. Nat Med. 2025 Mar;31(3):881-893. doi: 10.1038/s41591-024-03418-4. Epub 2025 Jan 3.

Drugs

Indications