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NCT04664179 · ClinicalTrials.gov registry record · Phase 1
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
A Phase 1 study of EBV-Related Hodgkin Lymphoma and EBV-Related Lymphoproliferative Disorder, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 2
- Study locations
NCT04664179 is a Phase 1 study of EBV-Related Hodgkin Lymphoma and EBV-Related Lymphoproliferative Disorder that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 52 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT04664179, a Phase 1 study of EBV-Related Hodgkin Lymphoma and EBV-Related Lymphoproliferative Disorder, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses. The investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators 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. The purpose of this study is to find the largest sa
Conditions Studied
Interventions
- BIOLOGICAL Dose Level 1A: 2 x 10^7 cells/m2
- BIOLOGICAL Dose Level 2A: 6 x 10^7 cells/m2
- BIOLOGICAL Dose Level 2B: 6 x 10^7 cells/m2
- BIOLOGICAL Dose Level 3B: 2 x 10^8 cells/m2
- BIOLOGICAL Dose Level 3A: 2 x 10^8 cells/m2
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2039-03-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04664179
The ClinicalTrials.gov registry entry for NCT04664179 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 EBV-Related Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Dose Level 1A: 2 x 10^7 cells/m2 is the first listed.
NCT04664179 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04664179 about?
NCT04664179 is a clinical study titled "EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma". This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma...
What is the current status of trial NCT04664179?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2022-10-31. Estimated completion is 2039-03-30.
What conditions does trial NCT04664179 study?
This clinical trial studies the following conditions: EBV-Related Hodgkin Lymphoma, EBV-Related Lymphoproliferative Disorder, EBV Related Non-Hodgkin's Lymphoma.
What interventions are being tested in trial NCT04664179?
The interventions under investigation include: Dose Level 1A: 2 x 10^7 cells/m2 (BIOLOGICAL), Dose Level 2A: 6 x 10^7 cells/m2 (BIOLOGICAL), Dose Level 2B: 6 x 10^7 cells/m2 (BIOLOGICAL), Dose Level 3B: 2 x 10^8 cells/m2 (BIOLOGICAL), Dose Level 3A: 2 x 10^8 cells/m2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04664179?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04664179 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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