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NCT02287311 · ClinicalTrials.gov registry record · Phase 1
Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)
A Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 2
- Study locations
NCT02287311 is a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 38 participants, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT02287311, a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Disease, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 2
- Study locations
Study Summary
The subject has a type of cancer or lymph gland disease associated with a virus called Epstein Barr Virus (EBV), which has come back, is at risk of coming back, or has not gone away after standard treatments. This research study uses special immune system cells called LMP, BARF-1 and EBNA1- specific cytotoxic T lymphocytes (MABEL CTLs). Some patients with Lymphoma (such as Hodgkin (HD) or non-Hodgkin Lymphoma (NHL)), T/NK-lymphoproliferative disease, or CAEBV, or solid tumors such as nasopharyngeal carcinoma (NPC), smooth muscle tumors, and leiomyosarcomas show signs of a virus called EBV before or at the time of their diagnosis. EBV causes mononucleosis or glandular fever ("mono" or the "kissing disease"). 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 (in lymphoma) and some immune system cells (in CAEBV) infected by EBV are able to hide from the body's immune system and escape destruction. EBV is also found in the majority of NPC and smooth muscle tumors, and some leiomyosarcomas. Investigators want to see if special white blood cells (MABEL CTLs) that have been trained to kill EBV infected cells can survive in patients blood and affect the tumor. In previous studies, EBV CTLs were generated from the blood of the patient, which was often difficult if the patient had recently received chemotherapy. Also, it took up to 1-2 months to make the cells, which is not practical when a patient needs more urgent treatment. To address these issues, the MABEL CTLs were made in the lab in a simpler, faster, and safer way. The MABEL CTLs will still see LMP proteins but also two other EBV proteins called EBNA-1 and BARF. To ensure these cells are available for use in patients in urgent clinical need, investigators have generated MABEL CTLs from the blood of healthy donors and created a bank of these cells, which are frozen until ready for use. Investigators have previously suc
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL MABEL CTLs
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-02 |
| Est. Completion | 2029-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02287311
The ClinicalTrials.gov registry entry for NCT02287311 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (75% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02287311 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02287311 about?
NCT02287311 is a clinical study titled "Most Closely Matched 3rd Party Rapidly Generated LMP, BARF1 And EBNA1 Specific CTL, EBV-Positive Lymphoma (MABEL)". The subject has a type of cancer or lymph gland disease associated with a virus called Epstein Barr Virus (EBV), which has come back, is at risk of coming back, or has not gone away after standard treatments. This research study uses special immune system cells called LMP, BARF-1 and EBNA1- specific...
What is the current status of trial NCT02287311?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2015-02. Estimated completion is 2029-03.
What conditions does trial NCT02287311 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Hodgkin Disease, Nasopharyngeal Carcinoma, Severe Chronic Active Epstein Barr Virus, T/NK-lymphoproliferative Disease.
What interventions are being tested in trial NCT02287311?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), MABEL CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT02287311?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287311 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.