Experimental virus therapy takes on deadly brain tumors
NCT ID NCT07472790
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Sanbo Brain Hospital, Capital Medical University
Beijing, Chaoyang District, China
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Other studies related to the condition(s) this trial covers.
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