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Experimental virus therapy takes on deadly brain tumors

NCT ID NCT07472790

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 15, 2026 · Updated 3 times

Summary

This early-stage trial tests a new treatment for recurrent high-grade glioma, an aggressive brain cancer. The approach uses a specially designed virus injected directly into the tumor to kill cancer cells and boost the immune system, combined with a PD-1 inhibitor drug that helps the immune system attack the cancer. The study will enroll 15 adults whose cancer has returned after standard treatment, to see if the combination is safe and how long they live.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oncolytic virus Ad-TD-nsIL12 combined with a PD-1 inhibitor
What this could lead to
If successful, this could point toward a new treatment option for recurrent high-grade glioma, a brain cancer with few effective therapies.
What could go wrong
This is a very early Phase 1 trial with only 15 people, so it is too soon to know if the combination works or is safe. The virus and immune drug may cause serious side effects, and the cancer may still progress.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Apr 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.

Inclusion Criteria: 1. Willing and able to provide written informed consent for the study 2. Be at least 18 years old from the date of signing the informed consent form 3. Patients with high-grade glioma (HGG) who have recurred/progressed after receiving standard treatment and confirmed to meet the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors by histopathology 4. According to the RANO 2.0 evaluation criteria, there is at least one measurable lesion, that is, the maximum vertical diameter of the lesion is ≥ 10mm 5. No diagnosis of immunodeficiency 6. Suitable for placement of Omaya capsule as judged by the investigator and eligible for intratumoral administration 7. KPS score ≥ 50 points, predicted survival ≥ 2 months 8. Organ function is good, as defined below: 1\) Blood routine (no blood transfusion or other treatment within 14 days): absolute neutrophil value ≥1.5×10\^9/L, platelet count ≥100×10\^9/L, hemoglobin ≥90g/L, white blood cell count ≥3.0×10\^9/L; 2) Coagulation function: thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN), international normalized ratio (INR) ≤ 1.5 times ULN; 3) Liver function: total bilirubin (TBIL) ≤1.5 times ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; 4) Renal function: serum creatinine ≤1.5 times ULN, or creatinine clearance ≥ 50 mL/min 9. Echocardiography shows normal cardiastolic function, left ventricular ejection fraction (LVEF) ≥50%, no pericardial effusion and severe arrhythmias 10. Participant has no active pulmonary infection 11. Participants are able to have gadolinium contrast enhanced scans 12. Participants and partners of childbearing potential and sexual activity must be willing to use a medically approved effective method of contraception, such as double-barrier contraception, during treatment and for 6 months after the last dose, and men agree not to donate sperm 13. Females of childbearing potential must have a negative blood pregnancy test result within 7 days prior to the first dose and are willing to undergo additional pregnancy testing during the study. Females of childbearing potential who have not been surgically sterilized (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or who are not postmenopausal; Menopause is the cessation of menstruation for 12 months in women over 45 years of age ≥ and excludes other causes of amenorrhea. In addition, serum follicle-stimulating hormone (FSH) levels in women under 50 years of age must be in the postmenopausal range to confirm menopause 14. Good compliance, willing and able to follow all research processes, and cooperate with observation and follow-up Exclusion Criteria: 1. Received treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose 2. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or need to undergo elective surgery during the study 3. Those who have a history of cell therapy, gene therapy, or oncolytic virus treatment 4. Patients who are unable to undergo magnetic resonance imaging (MRI) or single-photon emission computed tomography (SPECT) due to obesity or the presence of certain metals in the body, especially pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates 5. Known psychiatric disorder or substance abuse that would interfere with cooperation with the requirements of the study 6. Adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 6.0 grade ≤ grade 1 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.) 7. Pregnant or breastfeeding women 8. Presence of active hepatitis B or hepatitis C virus infection 9. History of immunodeficiency, including HIV/AIDS infection 10. Patients with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever \>38.5°C during screening and before the first dose 11. Allergy to immunotherapy and related drugs 12. Patients with current heart disease or poorly controlled hypertension requiring treatment 13. Patients with current unstable or active ulcers or gastrointestinal bleeding. 14. Patients with a history of organ transplantation or awaiting organ transplantation 15\. Severe coagulation disorders or other obvious evidence of bleeding risk; History of gastrointestinal bleeding; Any other bleeding event ≥ CTCAE2 level in the past 6 months 16. Participants who have received systemic steroid drugs (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents within 14 days before the first dose; The following are excluded: treatment with topical, ocular, intraarticular, intranasal, and inhaled corticosteroids; Short-term use of corticosteroids for prophylaxis (e.g., for contrast allergy prevention) 17. History of severe cardiovascular disease, such as ventricular arrhythmias requiring clinical intervention; QTc interval\> 480 ms; Acute coronary syndrome, congestive heart failure, stroke, or other grade III or above cardiovascular events within 6 months prior to the first dose; New York Heart Association (NYHA) cardiac function classification ≥ class II or left ventricular ejection fraction (LVEF) \< 50% 18. Other incurable malignancies within the past 3 years or at the same time, except for carcinoma in situ that is considered clinically curable, such as cervical cancer in situ and basal cell carcinoma of the skin 19. Participants have active or previously suffered autoimmune diseases with the possibility of recurrence (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroiditis 20. Individuals who have received live attenuated or recombinant vaccines within 4 weeks before the first administration, or inactivated vaccines within 2 weeks before the first administration 21. Individuals who have previously received immunotherapy and experienced irAE with a grade ≥3 22. Individuals with a history of encephalitis, multiple sclerosis, or other central nervous system infections 23. Individuals with cerebral herniation syndrome 24. Individuals deemed by the researchers to be unsuitable for participation in this clinical study for other reasons

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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

  • Sanbo Brain Hospital, Capital Medical University

    Beijing, Chaoyang District, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.