Oncolytic Virus Ad-TD-nsIL12 for Progressive Pediatric Diffuse Intrinsic Pontine Glioma

Study Purpose

This is a single-arm, single-center, drug safety assessment clinical trial with a 3+3 dose escalation design, to observe the safety, tolerability and toxicity of a novel oncolytic virus Ad-TD-nsIL12 intratumoral injection in progressive DIPG patients (NCI-CTCAE V5.0).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Year - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Informed consent of the parents or patient. 2. After surgical resection, biopsy, chemotherapy, or radiation therapy, tumor progression must be confirmed by MRI scan. 3. Biopsy is performed prior to injection of Ad-TD-nsIL12 to confirm DIPG (frozen section-based). 4. Pre-enrollment patients LPS (patients aged ≥1 and <16 years) and KPS (patients aged ≥16 years) ≥ 50. 5. Patient must be, in the investigator opinion, able to comply with all the protocol procedures. 6. Age 1-18 years. 7. A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile, including hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). 8. Lesion considered by the investigator to be accessible for stereotactic biopsy.

Exclusion Criteria:

1. Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow failure, which are not permitted for inclusion according to the investigator's criteria. Patients must be afebrile (<38℃) at the time of viral therapy. 2. Other investigational medications within 30 days prior to viral treatment. 3. Participants with immunodeficiency, autoimmune disease, or active hepatitis. 4. Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when younger than 16, or give informed consent or would compromise the patient's ability to tolerate therapy or any disease that will obscure toxicity or dangerously alter drug metabolism. 5. Tumor with multiple location. 6. Pregnant or breast-feeding females. 7. Severe bone marrow hypoplasia. 8. Transaminases (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin > 3 times the upper limit of normal. 9. Neutrophils < 1x10^9/L. 10. Platelets ≤ 100x10^9/L. 11. Hemoglobin < 9g/dl. 12. Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways. 13. Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration. 14. Blood transfusions or drugs (such as G-CSF) within 28 days before viral treatment to treat pancytopenia or other hematological disorders.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05717699
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Capital Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Hongwei Zhang, Prof.
Principal Investigator Affiliation Capital Medical University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Oncolytic Virus, Diffuse Intrinsic Pontine Glioma, Adverse Drug Event
Arms & Interventions

Arms

Experimental: Experimental Group

Multiple intratumoral injections of Ad-TD-nsIL12.

Interventions

Biological: - Ad-TD-nsIL12

After stereotactic biopsy, the Ommaya reservoir will be inserted through the biopsy channel and two injections of Ad-TD-nsIL12 will be delivered after surgery by Ommaya reservoir (with an interval of 3days). The interval between following injections in the subsequent treatment period will be 3 weeks ±4 days. The assigned dose for each patient will be 3x10^9vp, 1x10^10vp or 3x10^10 vp suspended in 1 ml NS according to cohort design.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Recruiting

Address

Sanbo Brain Hospital, Capital Medical University

Beijing, Beijing, 100010

Site Contact

Weihai Ning, Dr.

[email protected]

+86 15961868172

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