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

NCT04625205 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-04-06

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

NEO-PTC-01

Administered via intravenous infusion.

DRUG

IL-2

Administered via intravenous infusion.

DRUG

PD-1 Inhibitors

Administered via intravenous infusion.

Sponsors & Collaborators

  • BioNTech US Inc.

    lead INDUSTRY

Principal Investigators

  • BioNTech Responsible Person · BioNTech US Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-03-26
Completion
2025-03-26

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04625205 on ClinicalTrials.gov