NCT06660056

A Phase I Clinical Study of Intratumoral Injection GC001 in Patient With Recurrent or Progressive Gliomas

Recruiting now Phase 1 Last updated 13 March 2025

What this trial tests

Phase 1 trial testing A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain in High-grade Gliomas in 35 participants. Currently enrolling.

Timeline

8 October 2024

Primary endpoint
8 February 2026

8 August 2026

Quick facts

Lead sponsor	GONGCHU Biotechnology Co., Ltd
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	8 October 2024
Primary completion	8 February 2026
Estimated completion	8 August 2026
Sites	1 location across China

Drugs / interventions tested

• A Phase I Clinical Study of Intratumoral Injection Oncolytic Vaccinia Virus GC001 in Patient With Recurrent or Progressive Gliomas of the Brain

Conditions studied

• High-grade Gliomas — all drugs for High-grade Gliomas →

Sponsor

GONGCHU Biotechnology Co., Ltd

Who can join

18 and older, any sex, with High-grade Gliomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase I Study Evaluating the Safety, Tolerability, Biodistribution and Shedding of the Virus, Pharmacodynamics, Immunogenicity, and Antitumor Activity of GC001 Oncolytic Vaccinia Virus Injection in Patient With Recurrent or Progressive Gliomas .

Publications & conference data

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

1. Oncolytic Therapy: Delivery System and New Therapeutic Strategies for Cancer.
   Jin S, Zhang Y, Zhou Z, Zhang Y, et al · · 2026 · PMID 41970230 · DOI 10.1002/mco2.70725
2. Vaccinia Virus-A Swiss Army Knife Against Cancer.
   Stawowczyk M, Ye Y, Chen NG. · · 2025 · PMID 40723208 · DOI 10.3390/cancers17142324