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NCT01853631 · ClinicalTrials.gov registry record · Phase 1
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
A Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 2
- Study locations
NCT01853631 is a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 64 participants, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01853631, a Phase 1 study of Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 2
- Study locations
Study Summary
Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment. The body has different ways of fighting infection and disease. No one way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and T cells, hoping that they will work together. Both antibodies and T cells have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients. T cells can kill tumor cells but normally there are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person. The antibody used in this study is called anti-CD19. It first came from mice that have developed immunity to human lymphoma. This antibody sticks to lymphoma cells because of a substance on the outside of these cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, anti-CD19 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. In the laboratory, the investigators found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells last longer in the body but not long enough for them to be able to kill the lymphoma cells. The investigators believe that if they add an extra stimulating protein, called CD137, the cells will have a better chance of killing the lymphoma cells. The investigators are going to see if this is true by putting the CD19 chimeric receptor with CD28 alone into half of the cells and the CD19 ch
Conditions Studied
Interventions
- GENETIC Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells
- GENETIC Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2014-02 |
| Est. Completion | 2036-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01853631
The ClinicalTrials.gov registry entry for NCT01853631 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (65% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells is the first listed.
NCT01853631 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01853631 about?
NCT01853631 is a clinical study titled "Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)". Subjects on this study have a type of lymph gland cancer called Non-Hodgkin Lymphoma, acute lymphocytic leukemia, or chronic Lymphocytic Leukemia (these diseases will be referred to as "lymphoma" or "leukemia"). The lymphoma or leukemia has come back or has not gone away after treatment. The body h...
What is the current status of trial NCT01853631?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2014-02. Estimated completion is 2036-02.
What conditions does trial NCT01853631 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, Acute Lymphocytic Leukemia.
What interventions are being tested in trial NCT01853631?
The interventions under investigation include: Dose Escalation Phase:CD19.CAR/28 and CD19.CAR/28137 T cells (GENETIC), Expansion Phase: CD19.CAR/28 and CD19.CAR/28137 T cells (GENETIC).
Who is sponsoring clinical trial NCT01853631?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01853631 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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