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NCT04099797 · ClinicalTrials.gov registry record · Phase 1
C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)
A Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT04099797: Recruiting Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Baylor College of Medicine.
NCT04099797 is a Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 37 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (43% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04099797, a Phase 1 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, high grade glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare brain cancer that expresses GD2. Cohort 2 is for patients with a type of cancer called progressive pontine diffuse midline glioma (DMG), high grade glioma or diffuse intrinsic pontine glioma that expresses GD2. Because there is no standard treatment at this time, patients are asked to volunteer in a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that help the body fight infection. This research study combines two different ways of fighting cancer: antibodies and T cells. Both antibodies and T cells have been used to treat cancer patients. They have shown promise but have not been strong enough to cure most patients. Researchers have found from previous research that they can put a new antibody gene into T cells that will make them recognize cancer cells and kill them. GD2 is a protein found on several different cancers. Researchers testing brain cancer cells found that many of these cancers also have GD2 on their surface. In a study for neuroblastoma in children, a gene called a chimeric antigen receptor (CAR) was made from an antibody that recognizes GD2. This gene was put into the patients own T cells and given back to 11 patients. The cells did grow for a while but started to disappear from the blood after 2 weeks. The researchers think that if T cells are able to last longer they may have a better chance of killing tumor cells. In this study, a new gene will be added to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive. The gene C7R has been added that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. In other studies using T cells researchers found that giving chemotherapy
Primary Outcome
DLT rate is defined as the proportion of subjects with DLT evaluated as per the NCI CTCAE v5.0 with the exception of CRS and neurological toxicities that are related to T cell infusions.
Conditions Studied
Interventions
- GENETIC C7R-GD2.CART cells (IV and ICV infusion)
- GENETIC C7R-GD2.CAR T cells (IV infusion)
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-02-03 |
| Est. Completion | 2041-02 |
| Phase | Phase 1 |
What NCT04099797 shows while recruiting
NCT04099797 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (43% lower).
The record links to 4 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which C7R-GD2.CART cells (IV and ICV infusion) is the first listed.
NCT04099797 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04099797 about?
NCT04099797 is a clinical study titled "C7R-GD2.CAR T Cells for Patients With GD2-expressing Brain Tumors (GAIL-B)". In this study, there are two treatment groups called Cohort 1 and Cohort 2. Cohort 1 is for patients with diffuse midline glioma, high grade glioma, diffuse intrinsic pontine glioma, medulloblastoma, or another rare brain cancer that expresses GD2. Cohort 2 is for patients with a type of cancer call...
What is the current status of trial NCT04099797?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-02-03. Estimated completion is 2041-02.
What conditions does trial NCT04099797 study?
This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Embryonal Tumor, Ependymal Tumor.
What interventions are being tested in trial NCT04099797?
The interventions under investigation include: C7R-GD2.CART cells (IV and ICV infusion) (GENETIC), C7R-GD2.CAR T cells (IV infusion) (GENETIC).
Who is sponsoring clinical trial NCT04099797?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04099797 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT04099797's enrollment target sits among peer trials
37 19th of 42 higher than 24 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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