Clinical Trial Finder

Key

Inclusion Criteria:

• - 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.

Key

Exclusion Criteria:

• - Inability to undergo MRI examination for any reason.

• - Active hemorrhage observed before enrollment.

• - Imaging test: a.

lesion located in non-cerebral regions; b. there are other lesions outside target tumor cavity; c. extra-cranial metastasis.

• - Tumor lesion locates in ventricular system or there is a clear perforation between the tumor cavity and the ventricle after tumor resection.

• - History of encephalitis, multiple sclerosis or other central nervous system infections.

• - Treated with steroid hormones and/or more than 5 mg dexamethasone per day or other immunosuppressive drugs for systemic treatment within 4 weeks.

• - Persistent or active infection, and cannot be controlled by treatment.

• - Subjects with bleeding tendency or need to take anticoagulant drugs, antiplatelet drugs or non-steroidal anti-inflammatory drugs (NSAIDs) and are unable to discontinue.

• - Uncontrolled disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris.

• - Other malignant tumor within 5 years.

• - Patients who require an attenuated or live vaccine within 28 days prior to the first trial drug administration and during the study treatment period.

• - In the period of recurrent herpes simplex virus infection, with corresponding clinical manifestations.

• - Systemic use (other than topical) of anti-HSV drugs.

• - Prior treatment with any oncolytic virus, cell therapy or gene therapy.

• - Participants have a history of splenectomy, organ transplantation, bone marrow transplantation or stem cell transplantation.

• - Prior antitumor treatment with intracranial implants, such as Carmustine.

• - Previous history of allergic reactions to similar biological components such as HSV-1, IL-12 or anti-PD-1 antibodies, or with known allergic reactions to any component of the C5252 prescription, including glycerol.

• - Developed ≥Grade 3 irAE during previous immunotherapy.

• - History of frequent drug use (including "recreational use") or drug abuse (including alcohol abuse) within one year prior to signing the informed consent form.

• - Other situation that PI consider subjects not appropriate to participate in the study.

Arms

Experimental: Herpes Virus C5252 Injection

Interventions

Biological: - Herpes Virus C5252 Injection

C5252 will be administered at designed dose level.