RecruitingPhase 1NCT05835687

Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors

Loc3CAR: Locoregional Delivery of B7-H3-specific Chimeric Antigen Receptor Autologous T Cells for Pediatric Patients With Primary CNS Tumors

Sponsor

St. Jude Children's Research Hospital

Enrollment

48 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

Central Nervous System Neoplasms Glioblastoma High Grade Glioma Atypical Teratoid/Rhabdoid Tumor Medulloblastoma Ependymoma Diffuse Midline Glioma, H3 K27M-Mutant

Summary

Loc3CAR is a Phase I clinical trial evaluating the use of autologous B7-H3-CAR T cells for participants ≤ 21 years old with primary CNS neoplasms. B7-H3-CAR T cells will be locoregionally administered via a CNS reservoir catheter. Study participants will be divided into two cohorts: cohort A with B7-H3-positive relapsed/refractory non-brainstem primary CNS tumors, and cohort B with diffuse midline gliomas (DMG). Participants will receive four (4) B7-H3-CAR T cell infusions over a 4 week period. The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give patients with primary brain tumors. Primary objectives * To determine the safety, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for the locoregional delivery of autologous B7-H3-CAR T cells in patients ≤ 21 years of age with recurrent/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). Secondary objectives * To assess the efficacy, defined as sustained objective response, a partial response (PR) or complete response (CR) observed anytime on active treatment with B7-H3-CAR T cells in patients with relapsed/refractory B7-H3+ primary CNS tumors (Cohort A) or DMG (Cohort B). * To characterize and monitor neurologic toxicities in patients while on study (Cohort A and B).

Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study (Loc3CAR) is testing a specialized immune cell therapy called B7-H3-targeted CAR T cells — immune cells engineered to attack brain tumor cells — delivered directly into the brain or fluid surrounding the brain, for children and young adults with primary brain tumors. This includes recurrent or high-grade brain tumors that have not responded to standard treatments. **You may be eligible if...** - You are 21 years old or younger with a primary brain tumor - Your tumor has relapsed or is no longer responding to standard treatment, OR you have a specific type of dangerous brain tumor called diffuse midline glioma - Your tumor is confirmed to carry the B7-H3 protein marker (or specific mutation) - Your life expectancy is more than 12 weeks - Your performance status is adequate (Karnofsky/Lansky score of 50 or higher) **You may NOT be eligible if...** - You have significant other medical problems that would make the treatment too risky (heart, lung, liver, or serious psychiatric conditions) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGB7-H3-CAR T cells

Autologous T cells transduced with a lentiviral vector expressing a B7-H3-CAR with a CD28z signaling domain and 41BB ligand (B7-H3-CAR T cells). Four (4) infusions of B7-H3-CAR T cells will be locoregionally administered via CNS reservoir catheter.

Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

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NCT05835687

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