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NCT06186401 · ClinicalTrials.gov registry record · Phase 1
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells
A Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Hideho Okada, MD, PhD.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06186401: Recruiting Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Hideho Okada, MD, PhD.
NCT06186401 is a Phase 1 study of Glioblastoma and Recurrent Glioblastoma that is actively recruiting participants, run by Hideho Okada, MD, PhD. The registered enrollment target is 20 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06186401, a Phase 1 study of Glioblastoma and Recurrent Glioblastoma, is actively recruiting participants, sponsored by Hideho Okada, MD, PhD.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so the CAR T cells will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine before treatment with CAR T cells may make the CAR T cells more effective.
Primary Outcome
Treatment-emergent adverse events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Conditions Studied
Interventions
- PROCEDURE Leukapheresis
- PROCEDURE Surgical resection
- BIOLOGICAL E-SYNC T Cells
- DRUG Cyclophosphamide (non-investigational)
- DRUG Fludarabine (non-investigational)
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-04-30 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT06186401 shows while recruiting
NCT06186401 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (82% lower).
The record links to 4 conditions, with Glioblastoma appearing as the primary indexed condition, and to 5 interventions - of which Leukapheresis is the first listed.
NCT06186401 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06186401 about?
NCT06186401 is a clinical study titled "Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells". This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient...
What is the current status of trial NCT06186401?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-04-30. Estimated completion is 2027-12-31.
What conditions does trial NCT06186401 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma, EGFR Gene Mutation, MGMT-Unmethylated Glioblastoma.
What interventions are being tested in trial NCT06186401?
The interventions under investigation include: Leukapheresis (PROCEDURE), Surgical resection (PROCEDURE), E-SYNC T Cells (BIOLOGICAL), Cyclophosphamide (non-investigational) (DRUG), Fludarabine (non-investigational) (DRUG).
Who is sponsoring clinical trial NCT06186401?
This trial is sponsored by Hideho Okada, MD, PhD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06186401 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06186401's enrollment target sits among peer trials
20 148th of 199 higher than 46 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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