A Phase I-c Study of Recombinant GM-CSF Herpes Simplex Virus to TreatⅣ M1c

Status Recruiting

Clinical Trial Summary

Recombinant human GM-CSF herpes simplex virus injection (OrienX010) is a genetically engineered from Chinese patients oral separation of wild type 1 herpes simplex virus (HSV) as the carrier insert GM-CSF gene therapy drug.After gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human gm-csf gene.The drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after HSV-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;Viral vector expressed in tumor site, on the other hand, to produce high concentrations of GM-CSF enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.

Clinical Trial Description

Subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. Completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03048253
Study type	Observational
Source	OrienGene Biotechnology Ltd.
Contact	Zinan Xiao, MD
Phone	+86-15101193329
Email	znxiao@Oriengene.com
Status	Recruiting
Phase	N/A
Start date	March 29, 2016
Completion date	October 28, 2019

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