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High-grade GliomaPhase 1NCT07472790

A Study on the Novel Oncolytic Virus Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma

A Phase 1 study testing Novel oncolytic virus Ad-TD-nsIL12（BioTTT001） in people with High-grade Glioma, run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

A single-arm clinical study on the efficacy and safety of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in the treatment of recurrent high-grade glioma Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High-grade Glioma
What is being tested?
Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
31 Jul 2026to 30 Apr 2028
Phase
Phase 1
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

  • Willing and able to provide written informed consent for the study
  • Be at least 18 years old from the date of signing the informed consent form
  • 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
  • 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
  • No diagnosis of immunodeficiency
  • Suitable for placement of Omaya capsule as judged by the investigator and eligible for intratumoral administration
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  • KPS score ≥ 50 points, predicted survival ≥ 2 months
  • 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

Who cannot join

  • Received treatment with any other unmarketed investigational drug within 4 weeks prior to the first dose
  • 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
  • Those who have a history of cell therapy, gene therapy, or oncolytic virus treatment
  • 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
  • Known psychiatric disorder or substance abuse that would interfere with cooperation with the requirements of the study
  • 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.)
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  • Pregnant or breastfeeding women
  • Presence of active hepatitis B or hepatitis C virus infection
  • History of immunodeficiency, including HIV/AIDS infection
  • Patients with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever >38.5°C during screening and before the first dose
  • Allergy to immunotherapy and related drugs
  • Patients with current heart disease or poorly controlled hypertension requiring treatment
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

weihai ning contact

+8613161256767

sanboocean@163.com

China1 site

  • Sanbo Brain Hospital, Capital Medical University

    Beijing, Chaoyang District

    Hongwei Zhang, MD, +8618611163931, 62856705@163.com

Other trials in China

About this study

Official title: A Single-arm Clinical Study on the Efficacy and Safety of the Novel Oncolytic Virus Ad-TD-nsIL12 Combined With PD-1 Inhibitor in the Treatment of Recurrent High-grade Glioma

A single-arm clinical study on the efficacy and safety of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in the treatment of recurrent high-grade glioma

Read the detailed description

This study is a single-arm, single-center, exploratory clinical trial evaluating the preliminary efficacy and safety of the oncolytic virus Ad-TD-nsIL12 in combination with a PD-1 inhibitor for the treatment of recurrent HGG. It is planned to enroll 12-15 HGG patients and use a treatment regimen of Ad-TD-nsIL12 combined with a PD-1 inhibitor to preliminarily assess the efficacy and safety of this regimen.

Being tested
Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）Biological

    Inject Ad-TD-nsIL12 into the tumor via Ommaya reservoir, administering on days 1, 4, and 7, and infuse a PD-1 inhibitor on day 9.Ad-TD-nsIL12 is injected every 21 days (± 3 days) as appropriate in subsequent cycles. On the 7th day (±3 days) after oncolytic virus administration each cycle, a PD-1 inhibitor is given, or until disease progression or the occurrence of intolerable toxicity.

Study groups in NCT07472790
Study groupRoleWhat they receive
Evaluation of the efficacy of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitorsExperimentalImplant an Ommaya reservoir for intratumoral injection, dose 1.0×10¹⁰ vp
Receives: Biological: Novel oncolytic virus Ad-TD-nsIL12（BioTTT001）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the efficacy of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in treating recurrent HGG patients

    the time from the first oncolytic virus treatment to death from any cause; median OS was assessed

    Measured: Until death，12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2026
  2. Study start31 Jul 2026 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07472790
Sponsor's protocol ID
IIT-01-103
Status last verified
Jul 2026
First submitted
9 Mar 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Novel oncolytic virus Ad-TD-nsIL12（BioTTT001） in people with High-grade Glioma, run by Beijing Bio-Targeting Therapeutics Technology 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 9 inclusion and 14 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: opening soon, as of the sponsor's last update on 14 Jul 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 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.

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 weihai ning (+8613161256767, sanboocean@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the efficacy of the novel oncolytic virus Ad-TD-nsIL12 combined with PD-1 inhibitors in treating recurrent HGG patients (time frame: Until death，12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07472790.

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 14 Jul 2026.

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