Oncolytic Virus Plus CAR-T Cell Therapy
Oncolytic virus plus CAR-T cell therapy trial for solid tumors. Phase I/II study combining engineered viruses with immune cell therapy.
Phase I/II Study of Oncolytic Virus Therapy Combined with CAR-T Cells
Full Title
A phase I/II, open-label, dose-escalation study of engineered oncolytic virus therapy followed by chimeric antigen receptor T-cell infusion in patients with advanced solid tumors
Purpose
Oncolytic viruses are engineered to selectively infect and kill cancer cells while alerting the immune system to attack cancer. This study combines these viruses with CAR-T cell therapy to make solid tumors more vulnerable to immune attack and improve CAR-T cell effectiveness.
Primary Objectives
- Determine safety and maximum tolerated dose of oncolytic virus plus CAR-T cell combination
- Evaluate viral replication, spread, and immune activation within tumor microenvironment
- Assess CAR-T cell trafficking, persistence, and anti-tumor activity following viral priming
Diseases
Who Can Join this Trial
To participate in this study, you must meet ALL of the following criteria
- Have histologically confirmed advanced or metastatic solid tumor with progressive disease
- Have received at least one prior line of standard systemic therapy
- Have tumor lesions accessible for direct intratumoral virus injection
- Have adequate immune system function for CAR-T cell manufacturing
- ECOG performance status 0-2
- Age 18-70 years
- Life expectancy ≥16 weeks
- Adequate organ function including blood counts, liver, and kidney function
- No active viral infections or immunodeficiency disorders
- No concurrent systemic antiviral therapy
- No prior gene therapy or oncolytic virus treatment
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