Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05835687 · ClinicalTrials.gov registry record · Phase 1
Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors
A Phase 1 study of Glioblastoma and High Grade Glioma, sponsored by St. Jude Children's Research Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05835687 is a Phase 1 study of Glioblastoma and High Grade Glioma that is actively recruiting participants, run by St. Jude Children's Research Hospital. The registered enrollment target is 48 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05835687, a Phase 1 study of Glioblastoma and High Grade Glioma, is actively recruiting participants, sponsored by St. Jude Children's Research Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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).
Conditions Studied
Interventions
- DRUG B7-H3-CAR T cells
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2028-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05835687
The ClinicalTrials.gov registry entry for NCT05835687 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (56% lower). The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which B7-H3-CAR T cells is the first listed.
NCT05835687 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT05835687 about?
NCT05835687 is a clinical study titled "Loc3CAR: Locoregional Delivery of B7-H3-CAR T Cells for Pediatric Patients With Primary CNS Tumors". 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...
What is the current status of trial NCT05835687?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2023-04-27. Estimated completion is 2028-03.
What conditions does trial NCT05835687 study?
This clinical trial studies the following conditions: Glioblastoma, High Grade Glioma, Medulloblastoma, Ependymoma, Diffuse Midline Glioma, H3 K27M-Mutant.
What interventions are being tested in trial NCT05835687?
The interventions under investigation include: B7-H3-CAR T cells (DRUG).
Who is sponsoring clinical trial NCT05835687?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05835687 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
RECRUITING · Phase 1
-
A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma
RECRUITING · Phase 1
-
CARv3-TEAM-E T Cells in Glioblastoma
RECRUITING · Phase 1
-
CUE-102 in Recurrent Glioblastoma
RECRUITING · Phase 1
-
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
RECRUITING · Phase 1
-
Laser Interstitial Thermal Therapy (LITT) and Lomustine (CCNU) for Recurrent Glioblastoma
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.