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NCT07513194 · ClinicalTrials.gov registry record · Phase 1
GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)
A Phase 1 study, sponsored by Baylor College of Medicine.
- Not yet
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT07513194: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT07513194 is a Phase 1 study that has not yet begun recruiting, run by Baylor College of Medicine. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07513194, a Phase 1 study, has not yet begun recruiting, sponsored by Baylor College of Medicine.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for new therapies that can improve outcomes while minimizing toxicity. This study evaluates a new experimental treatment using genetically engineered T cells (RADIANT-T cells) that target glypican-3 (GPC3), a protein expressed on tumor cells. These T cells are modified to express a chimeric antigen receptor (CAR) targeting GPC3, along with IL-15 and IL-21 to enhance their persistence and activity. The cells also include an inducible safety mechanism (iCasp9) that allows them to be eliminated if necessary. The purpose of this study is to determine the highest safe dose of RADIANT-T cells, evaluate their safety and side effects, assess how long they persist in the body, and determine whether they show anti-tumor activity in patients with GPC3-positive brain tumors.
Primary Outcome
DLT will be defined as any of the following that may be considered possibly, probably, or definitely related to the 21.15.GPC3-CAR T cells: Any Grade 5 event, Non-hematologic dose-limiting toxicity (any Grade 4 non-hematologic toxicity that fails to return to Grade 2 within 72 hours), Grade 4 allergic reaction to CAR T cell administration, Grade 4 reactions due to CRS and neurotoxicity (rarely seen with the use of CAR-based immunotherapy), Grade 3 cytokine release syndrome (CRS) infusion reactio
Interventions
- BIOLOGICAL 21.15.GPC3-CAR T Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2044-10-31 |
| Phase | Phase 1 |
What is known before NCT07513194 opens enrollment
NCT07513194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 1 intervention - of which 21.15.GPC3-CAR T Cells is the first listed.
NCT07513194 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07513194 about?
NCT07513194 is a clinical study titled "GPC3 CAR T Cells With IL-15 and IL-21 for Recurrent ATRT and CNS Rhabdoid Tumors (RADIANT)". This study is being conducted in patients with GPC3-positive brain tumors that have recurred or have not responded to standard therapy. Atypical teratoid rhabdoid tumors (ATRT) are aggressive tumors with poor outcomes and limited treatment options, particularly in young children. There is a need for...
What is the current status of trial NCT07513194?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2026-09-01. Estimated completion is 2044-10-31.
What interventions are being tested in trial NCT07513194?
The interventions under investigation include: 21.15.GPC3-CAR T Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07513194?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07513194's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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