NCT04625205

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

Terminated Phase 1 Last updated 6 April 2025

What this trial tests

Phase 1 trial testing NEO-PTC-01 in Unresectable Melanoma in 22 participants. Terminated before completion.

Timeline

1 December 2020

Primary endpoint
26 March 2025

26 March 2025

Quick facts

Lead sponsor	BioNTech US Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	1 December 2020
Primary completion	26 March 2025
Estimated completion	26 March 2025
Sites	2 locations across Belgium, Netherlands

Drugs / interventions tested

• NEO-PTC-01 — full drug profile →
• IL-2 — full drug profile →
• PD-1 Inhibitors — full drug profile →

Conditions studied

• Unresectable Melanoma — all drugs for Unresectable Melanoma →
• Metastatic Melanoma — all drugs for Metastatic Melanoma →

Sponsor

BioNTech US Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Unresectable Melanoma or Metastatic Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neoantigens: promising targets for cancer therapy.
   Xie N, Shen G, Gao W, Huang Z, et al · · 2023 · cited 713× · PMID 36604431 · DOI 10.1038/s41392-022-01270-x
2. Neoantigen cancer vaccines: a new star on the horizon.
   Li X, You J, Hong L, Liu W, et al · · 2023 · cited 31× · PMID 38164734 · DOI 10.20892/j.issn.2095-3941.2023.0395
3. Adoptive T Cell Therapy for Solid Tumors: Pathway to Personalized Standard of Care.
   Qin SS, Melucci AD, Chacon AC, Prieto PA. · · 2021 · cited 29× · PMID 33916369 · DOI 10.3390/cells10040808
4. Personalized, autologous neoantigen-specific T cell therapy in metastatic melanoma: a phase 1 trial.
   Borgers JSW, Lenkala D, Kohler V, Jackson EK, et al · · 2025 · cited 25× · PMID 39753970 · DOI 10.1038/s41591-024-03418-4
5. The clinical impact of mRNA therapeutics in the treatment of cancers, infections, genetic disorders, and autoimmune diseases.
   Deyhimfar R, Izady M, Shoghi M, Kazazi MH, et al · · 2024 · cited 17× · PMID 38486748 · DOI 10.1016/j.heliyon.2024.e26971
6. Shaping the Future of Immunotherapy Targets and Biomarkers in Melanoma and Non-Melanoma Cutaneous Cancers.
   Spiliopoulou P, Vornicova O, Genta S, Spreafico A. · · 2023 · cited 10× · PMID 36674809 · DOI 10.3390/ijms24021294
7. Paving the Way to Solid Tumors: Challenges and Strategies for Adoptively Transferred Transgenic T Cells in the Tumor Microenvironment.
   Füchsl F, Krackhardt AM. · · 2022 · cited 8× · PMID 36077730 · DOI 10.3390/cancers14174192
8. The Identification and Clinical Applications of Mutated Antigens in the Era of Immunotherapy.
   Kye Y, Nagineni L, Gadad S, Ramirez F, et al · · 2022 · cited 7× · PMID 36077792 · DOI 10.3390/cancers14174255