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NCT05366179 · ClinicalTrials.gov registry record · Phase 1
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
A Phase 1 study of Glioblastoma Multiforme, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05366179: Recruiting Phase 1 study of Glioblastoma Multiforme, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT05366179 is a Phase 1 study of Glioblastoma Multiforme that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 36 participants, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05366179, a Phase 1 study of Glioblastoma Multiforme, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administration for glioblastoma.
Primary Outcome
Number of participants with adverse event (AE)s as a measure of safety and tolerability of intraventricular administration CAR.B7-H3 T cells in subjects with progressive recurrent or refractory glioblastoma multiforme. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Dose Limiting Toxicities (DLTs) are defined as at least possibly related to CAR.B7-H3T cell product administration.
Conditions Studied
Interventions
- DRUG CAR.B7-H3T cells infusion
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2030-05-30 |
| Phase | Phase 1 |
What NCT05366179 shows while recruiting
NCT05366179 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 96-participant average among 88 other Glioblastoma Multiforme trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Glioblastoma Multiforme appearing as the primary indexed condition, and to 1 intervention - of which CAR.B7-H3T cells infusion is the first listed.
NCT05366179 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05366179 about?
NCT05366179 is a clinical study titled "Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc". The purpose of this study is to test the safety of using T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (CAR.B7-H3T cells) in patients with glioblastoma. CAR.B7-H3T cells treatment has not been tested in humans and is not an approved treatment by the Food and Drug Administrat...
What is the current status of trial NCT05366179?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2022-09-02. Estimated completion is 2030-05-30.
What conditions does trial NCT05366179 study?
This clinical trial studies the following conditions: Glioblastoma Multiforme.
What interventions are being tested in trial NCT05366179?
The interventions under investigation include: CAR.B7-H3T cells infusion (DRUG).
Who is sponsoring clinical trial NCT05366179?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05366179 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glioblastoma Multiforme
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 NCT05366179's enrollment target sits among peer trials
36 52nd of 88 higher than 34 of 88 other Glioblastoma Multiforme trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma Multiforme 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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