GliomaPhase 1/2NCT07126990

Clinical Study of a Novel Oncolytic Virus Ad-TD-nsIL12 in the Treatment of Primary High-grade Glioma

A Phase 1/2 study testing Novel oncolytic virus Ad-TD-nsIL12 in people with Glioma, run by Xiaorong Wu at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

Search all trials

Trial summary

Clinical study of a novel oncolytic virus Ad-TD-nsIL12 in the treatment of primary high-grade glioma Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Glioma
What is being tested?: Novel oncolytic virus Ad-TD-nsIL12
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 12 Feb 2025to 30 Aug 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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18-80 years old (including cut-off value), both male and female;
Glioma that meets the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors and has not undergone any anti-tumor treatment;
The lesion is located in the non-functional area (Experiment 1) / the lesion is located in the functional area and thalamus (Experiment 2);
Have an intracranial measurable target lesion (refer to the iRANO standard);
Karnofsky Performance Score (KPS) ≥ 60 points;
Expected survival ≥ 3 months;

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Good organ function;
Subjects of childbearing potential and their partners who are sexually active must be willing to use a medically approved effective method of contraception, such as double-barrier contraception, during treatment and within 6 months after the last dose, and men agree not to donate sperm;
Subjects of reproductive potential and their partners who are sexually active must be willing to use medically recognized effective contraception methods during treatment and for 6 months after the last dose, such as double-barrier contraception, and male subjects must agree not to donate sperm;
Females of reproductive potential must have a negative blood pregnancy test result within 7 days prior to the first dose and be willing to undergo additional pregnancy tests during the study. Reproductive potential refers to women who have not undergone surgical sterilization (i.e., bilateral tubal ligation, bilateral oophorectomy, or total hysterectomy) or are not postmenopausal. Menopause is defined as 12 months of amenorrhea in women over 45 years old, excluding other causes of amenorrhea. Additionally, for women under 50, serum follicle-stimulating hormone (FSH) levels must be in the postmenopausal range to confirm menopause;
Good compliance, willing and able to follow all study procedures and cooperate with follow-up observations.

Who cannot join

Received any anti-tumor therapy (referring to the tumor to be observed) in the past;
Underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or required to undergo elective surgery during the study;
Known or suspected allergy to the active ingredients, excipients and contrast agents of the study drug;
Those with a history of organ transplantation or planned organ transplantation during the study;
Those with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever >38.5°C during screening and before the first dose;
Severe coagulation disorders or other obvious evidence of bleeding risk; History of gastrointestinal bleeding; Any other ≥ CTCAE grade 2 bleeding event in the past 6 months;

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Subjects 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 prophylactic treatment (e.g., to prevent contrast allergy);
Adverse reactions of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade ≤ grade 1 (except for toxicities judged by the investigator to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, etc.);
History of immunodeficiency, including positive HIV antibody test;
Active hepatitis B (HBsAg positive and HBV-DNA> 500 IU/ml or the lower limit of the test of the study center [only if the lower limit of detection of the study center is higher than 500 IU/ml]); Active hepatitis C (positive for HCV antibody and lower limit of HCV-RNA> detection by the study center), positive Treponema pallidum antibody;
Poorly controlled hypertension as judged by the investigator (arterial hypertension that is still uncontrolled under standard treatment: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);
History of severe cardiovascular disease, such as: ventricular arrhythmia 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 grade ≥ II or left ventricular ejection fraction (LVEF) < 50%;
Other uncured malignant tumors within or at the same time within the past 3 years, except for carcinoma in situ that is considered clinically curable, such as cervical cancer in situ and basal cell carcinoma of the skin;
Subjects with active or previously suffered autoimmune diseases that may recur (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for clinically stable autoimmune thyroiditis;
Those who have received live attenuated vaccines or recombinant vaccines within 4 weeks before the first dose, or inactivated vaccines within 2 weeks before the first dose;
Previous immunotherapy with irAE grade evaluation ≥3;
Those with two or more intracranial lesions, or extracranial metastasis;
Those with neoplastic lesions in the brainstem, cerebellum, posterior fossa or spinal cord, leptomeningeal disease;
Diffuse subependymal and subarachnoid disease;
Those with a history of encephalitis, multiple sclerosis, and other central nervous system infections;
Those with cerebral herniation syndrome;
Known alcohol or drug dependence;
Mental disorders or poor compliance;
Pregnant or lactating females;
The investigator believes that the subject has other serious systemic diseases or other reasons that are not suitable for participating in this clinical 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

Sanbo Brain Hospital, Capital Medical University
Beijing, Chaoyang District

Other trials in China

About this study

Clinical study of a novel oncolytic virus Ad-TD-nsIL12 in the treatment of primary high-grade glioma

Read the detailed description

This study will conduct two prospective, single-arm, single-center, exploratory clinical trials aimed at assessing the preliminary efficacy and safety of the novel oncolytic adenovirus Ad-TD-nsIL12 in treating primary HGG. Trial 1 will preliminarily evaluate the efficacy and safety of Ad-TD-nsIL12 as neoadjuvant treatment for patients with non-functional zone primary HGG; Trial 2 will preliminarily evaluate the efficacy and safety of Ad-TD-nsIL12 in treating patients with functional zone and thalamic primary HGG, as well as their quality of life.

Conditions: Glioma
Being tested: Novel oncolytic virus Ad-TD-nsIL12
Keywords: new oncolytic adenovirus, thalamic primary HGG
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-nsIL12Biological
Ommaya capsule was placed for intratumoral injection at a dose of 1×10^10vp

Study groups in NCT07126990
Study group	Role	What they receive
Treatment of patients with non-functional areas, functional areas and primary HGG of the thalamus	Experimental	Ommaya capsule was placed for intratumoral injection at a dose of 1x10^10vp Receives: Biological: Novel oncolytic virus Ad-TD-nsIL12

What is being measured

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

To evaluate the effectiveness of new oncolytic adenovirus Ad-TD-nsIL12 in the treatment of patients with non-functional zones, functional zones and thalamic primary HGG
12-month survival rate (OS12): defined as the proportion of cases of subjects who are still alive from 12 months after receiving treatment with the virus to the total number of cases
Measured: 12 months

Timeline

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

12 Feb 202530 Aug 2028

First posted17 Aug 2025
Study start12 Feb 2025
Primary completion30 Aug 2028 (estimated)
Study completion30 Aug 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for GliomaStudies 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: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07126990
Sponsor's protocol ID: IIT-01-107
Status last verified: Mar 2026
First submitted: 11 Aug 2025
Last updated: 23 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Glioma trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of a Novel Oncolytic Virus Ad-TD-nsIL12 in the Treatment of Primary High-grade Glioma
ClinicalTrials.gov ID: NCT07126990
Acronym / sponsor ID: IIT-01-107
Conditions: Glioma
Keywords: new oncolytic adenovirus, thalamic primary HGG
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 40 participants (estimated)
Lead sponsor: Xiaorong WuIndustry (pharma, biotech, devices)
Collaborators: Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Study start: 12 Feb 2025 (actual)
Primary completion: 30 Aug 2028 (estimated)
Study completion: 30 Aug 2028 (estimated)
First posted: 17 Aug 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.

Clinical study of a novel oncolytic virus Ad-TD-nsIL12 in the treatment of primary high-grade glioma

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment of patients with non-functional areas, functional areas and primary HGG of the thalamus	Experimental	Biological: Novel oncolytic virus Ad-TD-nsIL12Ommaya capsule was placed for intratumoral injection at a dose of 1x10^10vp

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age 18-80 years old (including cut-off value), both male and female;
Glioma that meets the 2021 edition of the World Health Organization (WHO) classification criteria for central nervous system tumors and has not undergone any anti-tumor treatment;
The lesion is located in the non-functional area (Experiment 1) / the lesion is located in the functional area and thalamus (Experiment 2);
Have an intracranial measurable target lesion (refer to the iRANO standard);
Karnofsky Performance Score (KPS) ≥ 60 points;

Key exclusion criteria (25 listed)

Received any anti-tumor therapy (referring to the tumor to be observed) in the past;
Underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks before the first dose, or required to undergo elective surgery during the study;
Known or suspected allergy to the active ingredients, excipients and contrast agents of the study drug;
Those with a history of organ transplantation or planned organ transplantation during the study;
Those with active infection or uncontrollable infection requiring intravenous systemic treatment, or unexplained fever >38.5°C during screening and before the first dose;

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
Novel oncolytic virus Ad-TD-nsIL12Ommaya capsule was placed for intratumoral injection at a dose of 1×10^10vp	Biological	Treatment of patients with non-functional areas, functional areas and primary HGG of the thalamus

Primary outcome

To evaluate the effectiveness of new oncolytic adenovirus Ad-TD-nsIL12 in the treatment of patients with non-functional zones, functional zones and thalamic primary HGG
Time frame: 12 months
12-month survival rate (OS12): defined as the proportion of cases of subjects who are still alive from 12 months after receiving treatment with the virus to the total number of cases

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 23 Mar 2026.
Individual participant dataSharing planned: No

Related trials for Glioma

Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma

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.

The record lists no contact. Use the official record to reach the sponsor.

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 Novel oncolytic virus Ad-TD-nsIL12 in people with Glioma, run by Xiaorong Wu 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 11 inclusion and 25 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: enrolling by invitation, as of the sponsor's last update on 23 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the effectiveness of new oncolytic adenovirus Ad-TD-nsIL12 in the treatment of patients with non-functional zones, functional zones and thalamic primary HGG (time frame: 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 NCT07126990.

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 23 Mar 2026.