NCT04664179 · Baylor College of Medicine
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
(CILESTE)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- AT TIME OF PROCUREMENT
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)- T/NK-lymphoproliferative disease who may subsequently be eligible for the treatment component
- EBV positive tumor (can be pending)
- Weighs at least 10 kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent.
- EBV positive Hodgkin's lymphoma
- EBV positive non-Hodgkin's Lymphoma (regardless of histologic subtype)
- EBV (associated)-T/NK-lymphoproliferative disease AND either A) In first or subsequent relapse or with persistent active disease despite therapy; OR B) With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study PI, in consultation with the primary provider as needed, e.g. patients who develop Hodgkin's disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of CLL. 2\) EBV positive tumor confirmed by pathology 3\) Patients with life expectancy ≥ 6 weeks 4\) Patients with bilirubin ≤ 3x upper limit of normal, AST ≤ 3x upper limit of normal, creatinine ≤ 2x upper limit of normal for age and Hgb ≥ 7.0 (may be a transfused value) 5\) Pulse oximetry of \>90% on room air 6\) Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. 7\) Patients with a Karnofsky/Lansky score of ≥ 50 8\) Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent. 3.
Exclusion criteria
- AT TIME OF PROCUREMENT 1\. Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement).
- Pregnant or breastfeeding
- Active and uncontrolled bacterial, viral or fungal infection
- Current use of systemic corticosteroids (prednisone equivalent \>0.5 mg/kg/day)
- Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement.
Where
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 25, 2026 · Source of record for eligibility and locations