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New treatment option for Oncolytic Virus
Official title Oncolytic Virus Ad-TD-nsIL12 for Primary Pediatric Diffuse Intrinsic Pontine Glioma
ClinicalTrials.gov ID: NCT05717712
What this study is testing
What is Ad-TD-nsIL12?
Ad-TD-nsIL12 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for oncolytic virus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 18
You may be able to join if
- Informed consent of the parents or patient.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Age 1-18 years.
- A negative pregnancy test in fertile women (women are considered of childbearing potential (WOCBP) after menarche, unless permanently infertile...
- Patient newly diagnosed of DIPG in MRI.
You likely can't join if
- Serious infections or intercurrent conditions, including but not limited to severe renal failure, liver failure, heart failure, or bone marrow...
- Other investigational medications within 30 days prior to viral treatment.
- Participants with immunodeficiency, autoimmune disease, or active hepatitis.
- Any medical or psychological condition that might interfere with the patient's ability to participate if older than 16 years or parents ability when...
- Tumor with multiple location.
- Pregnant or breast-feeding females.
See the full eligibility criteria
- Informed consent of the parents or patient.
- Patient must be, in the investigator opinion, able to comply with all the protocol procedures.
- Age 1-18 years.
- 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...
- Patient newly diagnosed of DIPG in MRI.
- Pre-enrollment patients LPS (patients aged ≥1 and \<16 years) and KPS (patients aged ≥16 years) ≥ 50.
- Lesion considered by the investigator to be accessible for stereotactic biopsy. The location of the lesion allows injection without virus entering the ventricular system.
- No previous treatment for DIPG.
- 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...
- Other investigational medications within 30 days prior to viral treatment.
- Participants with immunodeficiency, autoimmune disease, or active hepatitis.
- 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...
- Tumor with multiple location.
- Pregnant or breast-feeding females.
- Severe bone marrow hypoplasia.
- Transaminases (aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT)) or total bilirubin \> 3 times the upper limit of normal.
- Neutrophils \< 1x10\^9/L.
- Platelets ≤ 100x10\^9/L.
- Hemoglobin \< 9 g/dl.
- Patients with Li-Fraumini syndrome or a known germline defect in the retinoblastoma gene or its associated pathways.
- Administer any type of vaccine within 30 days prior to Ad-TD-nsIL12 administration.
- Blood transfusions or drugs (such as G-CSF) within 28 days before baseline to treat pancytopenia or other blood disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.