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ACTIVE NOT RECRUITING Phase 1

CART-EGFR-IL13Ra2 in EGFR Amplified Recurrent GBM

NCT05168423 · View on ClinicalTrials.gov ↗

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.

Conditions Studied

Interventions

  • DRUG CART-EGFR-IL13Ra2 Cells

Study Locations (1)

Pennsylvania

  • University of Pennsylvania — Philadelphia

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2023-02-24
Est. Completion 2039-12-19
Phase Phase 1

Sponsor

University of Pennsylvania

1,457 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05168423

The ClinicalTrials.gov registry entry for NCT05168423 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,457 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05168423 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05168423?

The interventions under investigation include: CART-EGFR-IL13Ra2 Cells (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05168423?

This trial is sponsored by University of Pennsylvania, which has 1,457 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial