RecruitingEarly Phase 1NCT05830240

A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer

A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer


Sponsor

Shanghai Yunying Medical Technology

Enrollment

9 participants

Start Date

Mar 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

9 participants are expected to be enrolled for this open,single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new type of cancer treatment called an oncolytic virus (R130 OV) — a modified virus that is injected directly into tumors and is designed to selectively destroy cancer cells — for people with recurrent or refractory head and neck cancer that has not spread to distant organs. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with head and neck cancer confirmed by biopsy or cytology - Your cancer has not spread to distant organs - Standard treatment has failed - You have at least one tumor that can be injected with the study drug - Your ECOG score is 0–2 and your expected survival is at least 3 months - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - You have had an allergic reaction to similar drugs - You have a blood cancer, a central nervous system tumor, or another active malignancy - You are pregnant or breastfeeding - You have active hepatitis B, hepatitis C, or HIV - You are taking antiviral medications like acyclovir or ganciclovir - You have had cancer treatment within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant oncolytic herpes simplex virus type 1 (R130)

R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11


Locations(1)

Eye & ENT Hospital of Fudan University

Shanghai, China

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NCT05830240


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