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NCT06482905 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.
A Phase 1 study of High Grade Glioma and WHO Grade Ⅳ Glioma, sponsored by Tcelltech.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 4
- Study locations
NCT06482905: Recruiting Phase 1 study of High Grade Glioma and WHO Grade Ⅳ Glioma, sponsored by Tcelltech.
NCT06482905 is a Phase 1 study of High Grade Glioma and WHO Grade Ⅳ Glioma that is actively recruiting participants, run by Tcelltech. The registered enrollment target is 52 participants, below the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target (19% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06482905, a Phase 1 study of High Grade Glioma and WHO Grade Ⅳ Glioma, is actively recruiting participants, sponsored by Tcelltech.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.
Primary Outcome
Type, incidence, and severity of dose limiting toxicities (DLTs) within 28 days after the first TX103 infusion.
Conditions Studied
Interventions
- BIOLOGICAL Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103
Study Locations (4)
Arizona
- Mayo Clinic in Arizona - Phoenix
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Beijing Municipality
- Beijing Tiantan Hospital - Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT06482905 shows while recruiting
NCT06482905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target (19% lower).
The record links to 2 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 1 intervention - of which Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 is the first listed.
NCT06482905 reports a single indexed study location in Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06482905 about?
NCT06482905 is a clinical study titled "Safety and Efficacy Study of TX103 CAR-T Cell Therapy for Recurrent or Progressive Grade 4 Glioma.". This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) a...
What is the current status of trial NCT06482905?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2024-09-04. Estimated completion is 2027-06.
What conditions does trial NCT06482905 study?
This clinical trial studies the following conditions: High Grade Glioma, WHO Grade Ⅳ Glioma.
What interventions are being tested in trial NCT06482905?
The interventions under investigation include: Anti-B7-H3 Chimeric Antigen Receptor T-Cell (CAR-T Cell) Injection/TX103 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06482905?
This trial is sponsored by Tcelltech, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06482905 being conducted?
This trial has 4 study locations across Arizona, Florida, Minnesota, Beijing Municipality. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06482905's enrollment target sits among peer trials
52 12th of 42 higher than 30 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma 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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