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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: Recruiting Phase 1 study of Glioblastoma and High Grade Glioma, sponsored by St. Jude Children's Research Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To determine the maximum tolerated dose for the locoregional delivery of autologous B7-H3-CAR T cells in patients with recurrent/refractory B7-H3- positive primary CNS tumors (Cohort A) or diffuse midline glioma (DMG) (Cohort 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 |
What NCT05835687 shows while recruiting
NCT05835687 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (56% lower).
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 a single indexed study location in 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
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Where NCT05835687's enrollment target sits among peer trials
48 90th of 199 higher than 106 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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