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NCT03774654 · ClinicalTrials.gov registry record · Phase 1
CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)
A Phase 1 study of Relapsed Non-Hodgkin Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 2
- Study locations
NCT03774654 is a Phase 1 study of Relapsed Non-Hodgkin Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 13 participants, below the 83-participant average among 16 other Relapsed Non-Hodgkin Lymphoma trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT03774654, a Phase 1 study of Relapsed Non-Hodgkin Lymphoma and Refractory B-Cell Non-Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is for patients who have lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to volunteer for a gene transfer research study using special immune 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 disease, antibodies and immune cells. Antibodies are types of proteins that protect the body from bacteria and other diseases. Immune cells, also called lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and lymphocytes have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the NKT cells, a special type of lymphocytes that can kill tumor cells but not very effectively on their own. When an antibody is joined to a T cell in this way it is called a chimeric receptor. Investigators have also found that NKT cells work better if proteins are added that stimulate lymphocytes, such as one called CD28. Adding the CD28 makes the cells last for a longer time in the body but maybe not long enough for them to be able to kill the lymphoma cells. It is believed that by adding an extra stimulating protein, called IL-15, the cells will have an even better chance of killing the lymphoma cells. In this study the investigators are going to see if this is true by putting the anti-CD19 chimeric receptor with CD28 and the IL-15 into NKT cells grown from a healthy i
Conditions Studied
Interventions
- GENETIC CD19.CAR-aNKT cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2020-06-22 |
| Est. Completion | 2035-02-28 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03774654
The ClinicalTrials.gov registry entry for NCT03774654 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 83-participant average among 16 other Relapsed Non-Hodgkin Lymphoma trials with a reported enrollment target (84% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Relapsed Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 1 intervention - of which CD19.CAR-aNKT cells is the first listed.
NCT03774654 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03774654 about?
NCT03774654 is a clinical study titled "CD19.CAR Allogeneic NKT for Patients With Relapsed or Refractory B-Cell Malignancies (ANCHOR)". This study is for patients who have lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to volunteer for a gene transfer research study using special immune cells. The body has different ways ...
What is the current status of trial NCT03774654?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2020-06-22. Estimated completion is 2035-02-28.
What conditions does trial NCT03774654 study?
This clinical trial studies the following conditions: Relapsed Non-Hodgkin Lymphoma, Refractory B-Cell Non-Hodgkin Lymphoma, Relapsed CLL, Refractory B-Cell Small Lymphocytic Lymphoma, Relapsed Adult ALL.
What interventions are being tested in trial NCT03774654?
The interventions under investigation include: CD19.CAR-aNKT cells (GENETIC).
Who is sponsoring clinical trial NCT03774654?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03774654 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.