NCT05717712 Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
| NCT ID | NCT05717712 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Capital Medical University |
| Condition | Oncolytic Virus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-01-04 |
| Primary Completion | 2025-01-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-01-04 with a primary completion date of 2025-01-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Hongwei Zhang, Prof.
PRINCIPAL INVESTIGATOR
Capital Medical University
Frequently Asked Questions
Who can join the NCT05717712 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying Oncolytic Virus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05717712 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05717712 currently recruiting?
Yes, NCT05717712 is actively recruiting participants. Contact the research team at ryan521q@sina.com for enrollment information.
Where is the NCT05717712 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05717712 clinical trial?
NCT05717712 is sponsored by Capital Medical University. The principal investigator is Hongwei Zhang, Prof. at Capital Medical University. The trial plans to enroll 18 participants.