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NCT03635632 · ClinicalTrials.gov registry record · Phase 1
C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)
A Phase 1 study of Uveal Melanoma and Refractory Neuroblastoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 94
- Enrollment target
- 2
- Study locations
NCT03635632: Active Phase 1 study of Uveal Melanoma and Refractory Neuroblastoma, sponsored by Baylor College of Medicine.
NCT03635632 is a Phase 1 study of Uveal Melanoma and Refractory Neuroblastoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 94 participants, below the 142-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (34% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03635632, a Phase 1 study of Uveal Melanoma and Refractory Neuroblastoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 94 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or another cancer that expresses a substance on the cancer cells called GD2. The cancer has either come back after treatment or did not respond to treatment. 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 helps the body fight infection. 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. 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. We have found from previous research that we can put a new gene into T cells that will make them recognize cancer cells and kill them. In our last clinical trial we made a gene called a chimeric antigen receptor (CAR) from an antibody that recognizes GD2, a substance found on almost all neuroblastoma cells (GD2-CAR). We put this gene into the patients' own T cells and gave them back to 11 neuroblastoma patients. We saw that the cells did grow for a while, but started to disappear from the blood after 2 weeks. We think that if T cells are able to last longer they may have a better chance of killing GD2 positive tumor cells. Therefore, in this study we will add a new gene to the GD2 T cells that can cause the cells to live longer. T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion. We have added the gene C7R 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, investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and the
Primary Outcome
Toxicity will be evaluated as per the NCI CTCAE version 5.0 with the exception of CRS and neurological toxicities that are related to T-cell infusions.
Conditions Studied
Interventions
- GENETIC C7R-GD2.CART cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-04-23 |
| Est. Completion | 2038-05-16 |
| Phase | Phase 1 |
What the registry record for NCT03635632 still lists
NCT03635632 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 142-participant average among 29 other Uveal Melanoma trials with a reported enrollment target (34% lower).
The record links to 7 conditions, with Uveal Melanoma appearing as the primary indexed condition, and to 1 intervention - of which C7R-GD2.CART cells is the first listed.
NCT03635632 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03635632 about?
NCT03635632 is a clinical study titled "C7R-GD2.CART Cells for Patients With Relapsed or Refractory Neuroblastoma and Other GD2 Positive Cancers (GAIL-N)". This study is for patients with neuroblastoma, sarcoma, uveal melanoma, breast cancer, or another cancer that expresses a substance on the cancer cells called GD2. The cancer has either come back after treatment or did not respond to treatment. Because there is no standard treatment at this time, pa...
What is the current status of trial NCT03635632?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 94 participants. The study started on 2019-04-23. Estimated completion is 2038-05-16.
What conditions does trial NCT03635632 study?
This clinical trial studies the following conditions: Uveal Melanoma, Refractory Neuroblastoma, Relapsed Neuroblastoma, Relapsed Osteosarcoma, Relapsed Ewing Sarcoma.
What interventions are being tested in trial NCT03635632?
The interventions under investigation include: C7R-GD2.CART cells (GENETIC).
Who is sponsoring clinical trial NCT03635632?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03635632 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03635632's enrollment target sits among peer trials
94 12th of 29 higher than 18 of 29 other Uveal Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uveal Melanoma 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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