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 four (4) weeks after the first b7-h3-car t-cell infusion or 7 days after the fourth b7-h3-car t cell infusion, whichever is longer

Awards & highlights

No Placebo-Only Group

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.

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.

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 ~ four (4) weeks after the first b7-h3-car t-cell infusion or 7 days after the fourth b7-h3-car t cell infusion, whichever is longer

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four (4) weeks after the first b7-h3-car t-cell infusion or 7 days after the fourth b7-h3-car t cell infusion, whichever is longer

This trial's timeline: 3 weeks for screening, Varies for treatment, and four (4) weeks after the first b7-h3-car t-cell infusion or 7 days after the fourth b7-h3-car t cell infusion, whichever is longer for reporting.