OncoMatch/Clinical Trials/NCT05835687
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
Is NCT05835687 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies B7-H3-CAR T cells for central nervous system neoplasms.
Treatment: B7-H3-CAR T cells — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Intrinsic Pontine Glioma
Glioblastoma
Biomarker criteria
Required: CD276 B7-H3 positive
tumor is B7-H3 positive
Required: H3C2 K27M
H3K27M mutation if pontine lesion
Required: H3C2 H3K27-altered
H3K27-altered diffuse midline pontine glioma
Prior therapy
Must have received: radiation therapy — Diffuse Midline Glioma (Cohort B) only
Must complete standard radiation prior to Loc3CAR treatment and be a minimum of 6 weeks post-completion of radiation therapy
Lab requirements
Blood counts
Hemoglobin >8.0 g/dL (can be transfused); Platelet count >50,000/mm^3 (can be transfused); ANC ≥1000/uL
Kidney function
Calculated creatinine clearance or radioisotope GFR ≥ 50 mL/min/1.73m^2
Liver function
Total Bilirubin ≤3 times the upper limit of normal for age; ALT and AST ≤5 times the upper limit of normal for age
Cardiac function
Echocardiogram with a left ventricular ejection fraction ≥ 50%
Echocardiogram with a left ventricular ejection fraction ≥ 50%; Calculated creatinine clearance or radioisotope GFR ≥ 50 mL/min/1.73m^2; FVC ≥50% of predicted value or pulse oximetry ≥90% on room air; Total Bilirubin ≤3 times the upper limit of normal for age; ALT and AST ≤5 times the upper limit of normal for age; Hemoglobin >8.0 g/dL (can be transfused); Platelet count >50,000/mm^3 (can be transfused); ANC ≥1000/uL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- St. Jude Children's Research Hospital · Memphis, Tennessee
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