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

Study Purpose

This is a 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 primary 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. Patient must be, in the investigator opinion, able to comply with all the protocol procedures. 3. Age 1-18 years. 4. 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). 5. Patient newly diagnosed of DIPG in MRI. 6. Pre-enrollment patients LPS (patients aged ≥1 and <16 years) and KPS (patients aged ≥16 years) ≥ 50. 7. Lesion considered by the investigator to be accessible for stereotactic biopsy. The location of the lesion allows injection without virus entering the ventricular system. 8. No previous treatment for DIPG.

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 at baseline (<38℃). 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 < 9 g/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 baseline to treat pancytopenia or other blood 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.	NCT05717712
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 3 days). 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

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