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NCT06198296 · ClinicalTrials.gov registry record · Phase 1
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells
A Phase 1 study of Hepatocellular Carcinoma and Rhabdomyosarcoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT06198296 is a Phase 1 study of Hepatocellular Carcinoma and Rhabdomyosarcoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 21 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06198296, a Phase 1 study of Hepatocellular Carcinoma and Rhabdomyosarcoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. In order to get them to kill cancers more effectively, in the laboratory, the study team inserted a new gene called a chimeric antigen receptor (CAR) into T cells that makes them recognize cancer cells and kill them. When inserted, this new CAR T cell can specifically recognize a protein found on solid tumors, called glypican-3 (GPC3). To make this GPC3-CAR more effective, the study team also added two genes called IL15 and IL21 that help CAR T cells grow better and stay in the blood longer so that they may kill tumors better. When the study team did this in the laboratory, they found that this mixture of GPC3-CAR,IL15 and IL21 killed tumor cells better when compared with CAR T cells that did not have IL15 plus IL21 in the laboratory. This study will use those cells, which are called 21.15.GPC3-CAR T cells, to treat patients with solid tumors that have GPC3 on their surface. The study team also wanted to make sure that they could stop the 21.15.GPC3-CAR T cells from growing in the blood should there be any bad side effects. In order to do so, they inserted a gene called iCasp9 into the CO-EXIST T cells. This allows us the elimination of 21.15.GPC3-CAR T cells in the blood when the gene comes into contact with a medication called AP1903. The drug (AP1903) is an experimental drug that has been tested in humans with no bad side-effects. This drug will only
Conditions Studied
Interventions
- GENETIC 21.15.GPC3-CAR T cells
Study Locations (1)
Texas
- Houston Methodist Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2025-06-10 |
| Est. Completion | 2043-02-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06198296
The ClinicalTrials.gov registry entry for NCT06198296 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (92% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which 21.15.GPC3-CAR T cells is the first listed.
NCT06198296 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06198296 about?
NCT06198296 is a clinical study titled "Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 Armored GPC3-CAR T Cells". The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly c...
What is the current status of trial NCT06198296?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2025-06-10. Estimated completion is 2043-02-01.
What conditions does trial NCT06198296 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Rhabdomyosarcoma, Wilms Tumor, Liposarcoma, Hepatoblastoma.
What interventions are being tested in trial NCT06198296?
The interventions under investigation include: 21.15.GPC3-CAR T cells (GENETIC).
Who is sponsoring clinical trial NCT06198296?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06198296 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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