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NCT01555892 · ClinicalTrials.gov registry record · Phase 1
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
A Phase 1 study of Lymphoma and Non-Hodgkin's Lymphoma, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 136
- Enrollment target
- 3
- Study locations
NCT01555892 is a Phase 1 study of Lymphoma and Non-Hodgkin's Lymphoma that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 136 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (72% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT01555892, a Phase 1 study of Lymphoma and Non-Hodgkin's Lymphoma, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 136 participants
- Enrollment target
- 3
- Study locations
Study Summary
Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases. Some of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called GRALE T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. Investigators have used this sort of therapy to treat a different type of cancer called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. Investigators grew T cells in the lab that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor cells and B cells only express 4 EBV proteins. In a previous study, the investigators made T cells that recognized all 9 proteins and gave them to patients with HD. Some patients had a partial response to this therapy but no patients had a complete response. The investigators then did follow up studies where investigators made T cells that recognized the 2 EBV proteins seen in patients with lymphoma, T/NK-lymphoproliferative disease and CAEBV. Investigators have treated over 50 people on those studies. About 60% of those patients who had disease at the time they got the cells had responses including
Conditions Studied
Interventions
- BIOLOGICAL EBV-specific T cells: A
- BIOLOGICAL EBV-specific T cells: B
Study Locations (3)
Texas
- Harris Health System (includes ben Taub General Hospital and Smith) - Houston
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2013-01-14 |
| Est. Completion | 2027-07-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01555892
The ClinicalTrials.gov registry entry for NCT01555892 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (72% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which EBV-specific T cells: A is the first listed.
NCT01555892 reports 3 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01555892 about?
NCT01555892 is a clinical study titled "Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE". Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators ...
What is the current status of trial NCT01555892?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 136 participants. The study started on 2013-01-14. Estimated completion is 2027-07-01.
What conditions does trial NCT01555892 study?
This clinical trial studies the following conditions: Lymphoma, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Lymphoproliferative Disease.
What interventions are being tested in trial NCT01555892?
The interventions under investigation include: EBV-specific T cells: A (BIOLOGICAL), EBV-specific T cells: B (BIOLOGICAL).
Who is sponsoring clinical trial NCT01555892?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01555892 being conducted?
This trial has 3 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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