A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor
This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.
• Age ≥ 18 years.
• Confirmed recurrent malignant high-grade (WHO grade 3-4) glioma who have received standard therapy and no available treatment.
• Measurable lesions exist in accordance with RANO criteria.
• Sufficient space for ≥1 mL drug infused into tumor cavity post resection.
• Ommaya reservoir has been placed in the operation area, and drug administration conditions are available.
• Karnofsky Performance Status (KPS) ≥ 60%
• Life expectancy \> 12 weeks.
• No severe hematological, cardiovascular, liver or kidney diseases.
• If the patient is a sexually active female of childbearing potential or if the patient is a sexually active male whose partner is a female of childbearing potential, the patient must use appropriate contraceptive measures for the duration of the treatment and for 6 months afterwards. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of before the C5252 infusion.
• Capable of understanding and complying with protocol requirements.