Actively Recruiting
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Led by Baylor College of Medicine · Updated on 2025-12-12
52
Participants Needed
2
Research Sites
856 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.
CONDITIONS
Official Title
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma or EBV-associated T/NK-lymphoproliferative disease at time of blood donation
- EBV positive tumor (results can be pending at time of donation)
- Weighs at least 10 kg
- Informed consent understood and signed by patient or guardian
- Diagnosis of EBV positive Hodgkin's lymphoma, non-Hodgkin's lymphoma, or T/NK-lymphoproliferative disease at time of infusion
- Disease in first or later relapse or persistent active disease despite therapy, or active disease if immunosuppressive chemotherapy is not an option
- EBV positive tumor confirmed by pathology
- Life expectancy of 6 weeks or more
- Bilirubin less than or equal to 3 times upper limit of normal
- AST less than or equal to 3 times upper limit of normal
- Creatinine less than or equal to 2 times upper limit of normal for age
- Hemoglobin level of 7.0 or higher (may be a transfused value)
- Pulse oxygen level greater than 90% on room air
- Off other investigational therapies for at least 4 weeks before study entry
- Karnofsky/Lansky performance score of 50 or higher
- Informed consent understood and signed by patient or guardian
You will not qualify if you...
- Pregnant or breastfeeding at time of blood donation
- Pregnant or breastfeeding at time of infusion
- Active and uncontrolled bacterial, viral, or fungal infection
- Current use of systemic corticosteroids above 0.5 mg/kg/day prednisone equivalent
- Bulky disease causing or risking airway obstruction
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
B
Bilal Omer, MD
CONTACT
D
Dustin McFadden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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