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CAR T-cell Therapy
B7-H3-CAR T Cells for Brain Tumor
Phase 1
Recruiting
Led By Christopher DeRenzo, MD
Research Sponsored by St. Jude Children's Research 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 eight (8) weeks after the first b7-h3-car t-cell infusion or 7 days after the sixth b7-h3-car t cell infusion, whichever is longer
Awards & highlights
Study Summary
This trial is testing if a new way of delivering cancer-fighting cells to people with brain tumors is safe. Participants will get 6 doses given over 8 weeks.
Who is the study for?
The Loc3CAR trial is for children and young adults up to 21 years old with primary brain tumors. Participants must have measurable disease, a life expectancy over 8 weeks, and be able to perform daily activities at least half of the time (Karnofsky/Lansky score ≥50). They should not have severe infections or immune deficiencies, non-programmable ventricular shunts, or any condition that could affect study results.Check my eligibility
What is being tested?
This Phase I trial tests B7-H3-CAR T cells delivered directly into the central nervous system via a catheter in patients with two types of brain tumors: relapsed/refractory non-brainstem tumors (Cohort A) and high-grade brainstem neoplasms (Cohort B). The goal is to determine the highest safe dose through six infusions over eight weeks.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, symptoms due to infusion like fever or chills, fatigue from treatment burden on the body's systems, possible blood-related issues such as anemia or clotting problems, and increased risk of infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ eight (8) weeks after the first b7-h3-car t-cell infusion or 7 days after the sixth b7-h3-car t cell infusion, whichever is longer
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~eight (8) weeks after the first b7-h3-car t-cell infusion or 7 days after the sixth b7-h3-car t cell infusion, whichever is longer
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD)
Secondary outcome measures
Sustained objective radiographic response
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (brainstem high-grade neoplasms)Experimental Treatment1 Intervention
Patients with high-grade neoplasms
Group II: Arm A (relapsed/refractory CNS tumors)Experimental Treatment1 Intervention
Patients with B7-H3-positive relapsed/refractory non-brainstem primary CNS tumors.
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Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
428 Previous Clinical Trials
5,306,577 Total Patients Enrolled
2 Trials studying Atypical Teratoid/Rhabdoid Tumor
68 Patients Enrolled for Atypical Teratoid/Rhabdoid Tumor
Christopher DeRenzo, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
Kelsey Bertrand, MD, MScPrincipal InvestigatorSt. Jude Children's Research Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain tumor is B7-H3 positive, H3K27-altered, or a typical DIPG.I am a man who can father children and agree to use birth control.I have stopped certain treatments for a specific time before joining.I am 21 years old or younger.I am not pregnant, not breastfeeding, and agree to use birth control if I'm sexually active.I am 21 years old or younger.I have a brain tumor that can be measured and fits into one of the study groups.I can do most activities but may need help.I can understand and sign the consent form myself, or I have a guardian who can.I have a brain tumor that can be measured.My CNS tumor has returned or didn't respond to treatment, and it's not in my brainstem.I can do most activities but may need help.I have recovered from the side effects of my previous cancer treatment.My CNS tumor has returned or didn't respond to treatment and tests positive for B7-H3.My organs are functioning well, my lab results are within normal ranges, and I am on anti-seizure medication.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (relapsed/refractory CNS tumors)
- Group 2: Arm B (brainstem high-grade neoplasms)
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.
How precarious is Arm A (relapsed/refractory CNS tumors) for the participants?
"Though limited efficacy and safety data is available, our team at Power assessed Arm A's (relapsed/refractory CNS tumors) security to be a 1 on the 3-point scale."
Answered by AI
Are any openings available for patients to join this experiment?
"Unfortunately, this particular clinical trial is not actively looking for participants as of now. The most recent edit on the study's page was made on April 18th 2023. However, 860 other trials are currently recruiting patients for their studies."
Answered by AI
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