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CAR T-cell Therapy
CAR T Cell Therapy for Pediatric Brain Cancer
Phase 1
Recruiting
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days post-final sc-car4brain infusion
Awards & highlights
Study Summary
This trial uses bioengineered T cells to target tumors in children/young adults with Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, or other recurrent/refractory CNS tumors via an indwelling catheter into the ventricular system.
Who is the study for?
This trial is for children and young adults with specific brain tumors like DIPG, DMG, or recurrent/refractory CNS tumors. They must have a life expectancy of at least 8 weeks, be in good physical condition (Lansky/Karnofsky score ≥ 60), have proper organ function, agree to use contraception if applicable, and have a catheter placed for treatment delivery.Check my eligibility
What is being tested?
The study tests SC-CAR4BRAIN therapy using the patient's own T cells engineered to target tumor cells via CARs that recognize B7-H3, EGFR806, HER2, and IL13-zetakine. The modified T cells are delivered directly into the brain through a catheter. Patients are divided into two groups based on their type of tumor.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as inflammation in various organs or tissues due to targeted cell destruction by CAR T-cells; infusion-related reactions; fatigue; possible neurological symptoms from direct brain administration.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 28 days post-final sc-car4brain infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days post-final sc-car4brain infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Administration feasibility
Dose level
Manufacturing Feasibility
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B - DMG & recurrent/refractory tumorsExperimental Treatment1 Intervention
Group II: Arm A - DIPGExperimental Treatment1 Intervention
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Who is running the clinical trial?
Seattle Children's HospitalLead Sponsor
304 Previous Clinical Trials
5,217,228 Total Patients Enrolled
2 Trials studying Diffuse Intrinsic Pontine Glioma
143 Patients Enrolled for Diffuse Intrinsic Pontine Glioma
Nick VitanzaStudy ChairSeattle Children's Hospital
Rebecca Ronsley, MDStudy ChairSeattle Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently suffering from a severe infection.I am between 1 and 26 years old, or between 12 and 26 for the first 3 subjects.I have a condition that affects my immune system or bone marrow.My brain or spinal cord disease is not responding to treatment and there are no standard treatments left.I have recovered from the side effects of my previous cancer treatments.I can care for myself but may need occasional help.I have another active cancer besides the brain tumor being studied.My disease was identified as DIPG after completing standard radiotherapy.I am at risk of brain herniation.I have severe heart issues or irregular heartbeats needing treatment.My organs are working well.I can undergo apheresis or already have an apheresis product ready for use.I have a catheter in place for brain-directed treatment.I have severe swallowing difficulties.My corticosteroid dose is stable or decreasing.My disease was classified as DMG after completing standard radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A - DIPG
- Group 2: Arm B - DMG & recurrent/refractory tumors
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the minimum age requirement for this trial above or below twenty years?
"This study is available for individuals between 1 and 26 years old."
Answered by AI
What degree of risk do participants in Arm A - DIPG face?
"Given that this is a Phase 1 trial with limited evidence for safety and efficacy, Arm A - DIPG received an estimated score of 1."
Answered by AI
Could I be a potential participant in this research endeavor?
"Eligibility criteria for this research trial include a diagnosis of diffuse intrinsic pontine glioma and an age range between one year old to twenty-six. A total of seventy-two patients are needed in order to complete the study."
Answered by AI
Are there any current openings in this experiment?
"Unfortunately, according to the entries on clinicaltrials.gov, recruitment for this medical trial has already concluded. It was initially posted in late April of 2023, and subsequently edited shortly after that date. However, there are currently 3674 other trials actively seeking participants at present time."
Answered by AI
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