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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 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.

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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.

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

FieldValue
Enrollment Target 52 participants
Start Date 2024-09-04
Est. Completion 2027-06
Phase Phase 1

Sponsor

Tcelltech

1 total trials

What the Registry Record Tells You About NCT06482905

The ClinicalTrials.gov registry entry for NCT06482905 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 64-participant average among 42 other High Grade Glioma trials with a reported enrollment target (19% lower). The listed sponsor is Tcelltech, which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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