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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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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.

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
433 Previous Clinical Trials
5,307,714 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

B7-H3-CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05835687 — Phase 1
Atypical Teratoid/Rhabdoid Tumor Research Study Groups: Arm A (relapsed/refractory CNS tumors), Arm B (brainstem high-grade neoplasms)
Atypical Teratoid/Rhabdoid Tumor Clinical Trial 2023: B7-H3-CAR T cells Highlights & Side Effects. Trial Name: NCT05835687 — Phase 1
B7-H3-CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05835687 — Phase 1
~24 spots leftby Mar 2028