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NCT05168423 · ClinicalTrials.gov registry record · Phase 1
CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM
A Phase 1 study of Glioblastoma, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT05168423: Active Phase 1 study of Glioblastoma, sponsored by University of Pennsylvania.
NCT05168423 is a Phase 1 study of Glioblastoma that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 67 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05168423, a Phase 1 study of Glioblastoma, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following prior radiotherapy. This study will take place in two parts: an initial dose escalation phase followed by a dose exploration phase. In the dose expansion phase, the maximum tolerated dose (MTD) of CART-EGFR-IL13Ra2 cells will be determined using a standard 3+3 design. Once the MTD has been determined, the dose exploration phase will allow for further identification of a recommended dose for expansion (RDE) as well as the safety and feasibility of alternative dosing schedules.
Primary Outcome
Type, frequency, severity, and attribution of adverse events
Conditions Studied
Interventions
- DRUG CART-EGFR-IL13Ra2 Cells
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2023-02-24 |
| Est. Completion | 2039-12-19 |
| Phase | Phase 1 |
What the registry record for NCT05168423 still lists
NCT05168423 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 1 intervention - of which CART-EGFR-IL13Ra2 Cells is the first listed.
NCT05168423 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05168423 about?
NCT05168423 is a clinical study titled "CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM". This is an open-label phase 1 study to assess the safety and feasibility of autologous T cells co-expressing two CARs targeting the cryptic EGFR epitope 806 and IL13Ra2 (referred to as "CART-EGFR-IL13Ra2 cells") in patients with EGFR-amplified glioblastoma, IDH-wildtype that has recurred following p...
What is the current status of trial NCT05168423?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2023-02-24. Estimated completion is 2039-12-19.
What conditions does trial NCT05168423 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT05168423?
The interventions under investigation include: CART-EGFR-IL13Ra2 Cells (DRUG).
Who is sponsoring clinical trial NCT05168423?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05168423 being conducted?
This trial has 1 study location across Pennsylvania. 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.
Where NCT05168423's enrollment target sits among peer trials
67 65th of 199 higher than 134 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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