Glioma, MalignantPhase 1/2NCT07243340
A Phase I/IIa Study of C5252 in Patients With Intracranial Tumor
A Phase 1/2 study testing Herpes Virus C5252 Injection in people with Glioma, Malignant, run by ImmVira Pharma Co. Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Malignant
- What is being tested?
- Herpes Virus C5252 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2026to 15 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Wenliang Li, 86+512+66202028, xinyi.liu@immviragroup.com
xinyi.liu@immviragroup.com
About this study
Official title: 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.
- Conditions
- Glioma, Malignant
- Being tested
- Herpes Virus C5252 Injection
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herpes Virus C5252 InjectionBiological
C5252 will be administered at designed dose level.
| Study group | Role | What they receive |
|---|---|---|
| Herpes Virus C5252 Injection | Experimental | Not described Receives: Biological: Herpes Virus C5252 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of adverse event
TEAE, SAE, DLT, AESI during treatment period
Measured: Up to 30 days after completion of treatment
Phase I: Determine the MTD/RP2D
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
Measured: up to 4 weeks
Phase II: Overall Survival
The overall survival for each patient receiving C5252 will be calculated.
Measured: Up to 2 years
Phase II: OS rate
OS rate at 6, 12, 18 and 24 months after first study dose
Measured: Up to 2 years after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start3 Apr 2026
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmVira Pharma Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243340
- Sponsor's protocol ID
- MVR-C5252-003
- Status last verified
- Aug 2026
- First submitted
- 16 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Herpes Virus C5252 Injection in Patients With Intracranial Tumor
- ClinicalTrials.gov ID
- NCT07243340
- Acronym / sponsor ID
- MVR-C5252-003
- Conditions
- Glioma, Malignant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- ImmVira Pharma Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2026 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Herpes Virus C5252 Injection | Experimental | Biological: Herpes Virus C5252 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herpes Virus C5252 InjectionC5252 will be administered at designed dose level. | Biological | Herpes Virus C5252 Injection |
Primary outcome
Phase I: Incidence of adverse event
Time frame: Up to 30 days after completion of treatment
TEAE, SAE, DLT, AESI during treatment period
Phase I: Determine the MTD/RP2D
Time frame: up to 4 weeks
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
Phase II: Overall Survival
Time frame: Up to 2 years
The overall survival for each patient receiving C5252 will be calculated.
Phase II: OS rate
Time frame: Up to 2 years after first dose
OS rate at 6, 12, 18 and 24 months after first study dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Herpes Virus C5252 Injection in people with Glioma, Malignant, run by ImmVira Pharma Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyi Liu (86+512+66202028, xinyi.liu@immviragroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence of adverse event (time frame: Up to 30 days after completion of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.