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 (Jun 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
Treatments studied
Other
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
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05835687 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received radiation therapy.
Does this trial require CD276?
Yes, CD276 B7-H3 positive is a required biomarker for enrollment.
Does this trial require H3C2?
Yes, H3C2 K27M is a required biomarker for enrollment.
Does this trial require H3C2?
Yes, H3C2 H3K27-altered is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 21 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify