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Cold war on brain cancer: herpes virus injected into tumors in new trial

NCT ID NCT07243340

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 2 times

Summary

This early-stage trial tests a modified herpes virus (C5252) injected directly into the brain tumor cavity of 36 adults with recurrent high-grade glioma who have run out of standard options. The goal is to see if the virus is safe and can help control the disease. Participants will receive one or more doses and be followed for side effects and survival.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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