A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor

NCT07243340 | Not Yet Recruiting Phase 1

• 1 other identifier: MVR-C5252-003
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma, Malignant

Outcome Measures

Primary Outcomes (4)

• Phase I: Incidence of adverse event

  TEAE, SAE, DLT, AESI during treatment period

  Up to 30 days after completion of treatment

• Phase I: Determine the MTD/RP2D

  Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)

  up to 4 weeks

• Phase II: Overall Survival

  The overall survival for each patient receiving C5252 will be calculated.

  Up to 2 years

• Phase II: OS rate

  OS rate at 6, 12, 18 and 24 months after first study dose

  Up to 2 years after first dose

Study Arms (1)

Herpes Virus C5252 Injection

EXPERIMENTAL

Biological: Herpes Virus C5252 Injection

Interventions

Herpes Virus C5252 Injection BIOLOGICAL

C5252 will be administered at designed dose level.

Herpes Virus C5252 Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ImmVira Pharma Co. Ltd: lead

Study Sites (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Xinyi Liu

CONTACT

86+512+66202028; xinyi.liu@immviragroup.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 21, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

CN (1)