Constitutive Interleukin-7 Cytokine Signaling Enhances the Persistence of Epstein-Barr Virus-Specific T-Cells.
Sandhya Sharma, Tim Sauer, Bilal A Omer...
https://pubmed.ncbi.nlm.nih.gov/37958791/Actively Recruiting
Led by Baylor College of Medicine · Updated on 2026-06-25
52
Participants Needed
4
Research Sites
782 weeks
Total Duration
Researchers are evaluating a treatment for patients with Hodgkin or non-Hodgkin Lymphoma or TNK-lymphoproliferative disease that has returned or not improved after prior treatments. Many patients with these diseases have cancer cells infected by the Epstein Barr virus EBV, which can help the cancer evade the immune system. This study aims to find the highest safe dose of specially modified T cells that target EBV-infected cells and to assess how long these cells survive in the body and their effect on the cancer. Participants will provide blood to create C7R-EBV T cells, which are modified T cells made to live longer by adding a gene called C7R. Patients are assigned a dose of these cells based on their size. Some may receive chemotherapy with cyclophosphamide and fludarabine before the T cell infusion to prepare their body for the treatment. The T cells are given through an IV, and patients will be monitored closely in the clinic or hospital for side effects. If needed, patients may receive a second infusion of the T cells after at least six weeks. During the study, participants will have physical exams, blood tests, and imaging scans to track their cancer and monitor safety. Extra blood samples will be taken at specific times to study the T cells in the body, with follow-up visits continuing annually for up to 15 years to watch for long-term effects. Patients will also receive supportive care for any side effects or complications. Total participation may last many years due to long-term monitoring.
CONDITIONS
EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma
B
Bilal Omer, MD
D
Dustin McFadden
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Baylor College of Medicine
Lead Sponsor
The Methodist Hospital Research Institute
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | EBV‑specific T‑cell therapy (dose‑escalation trial) | Current standard chemotherapy option |
|---|---|---|
| What it is | An investigational therapy using Epstein‑Barr virus‑specific T‑lymphocytes administered at escalating dose levels, with or without lymphodepletion chemotherapy | Established chemoimmunotherapy regimens such as R‑CHOP for Epstein‑Barr virus‑positive diffuse large B‑cell lymphoma or ABVD for Epstein‑Barr virus‑positive Hodgkin lymphoma |
| Role in trial | Participants receive the experimental EBV‑specific T‑cells in escalating doses, with or without prior lymphodepletion | Not used in the trial, included here for external clinical context |
| Primary use | To treat relapsed, refractory, or treatment‑ineligible EBV‑positive lymphoma using targeted T‑cell immunotherapy | Standard treatment approach for EBV‑positive lymphomas responsive to chemoimmunotherapy |
| How it is given | Infusion of EBV‑specific T‑lymphocytes at escalating dose levels, with option of lymphodepletion chemotherapy beforehand | Administered as standard multi‑agent chemotherapy cycles (for example R‑CHOP or ABVD) according to lymphoma subtype |
| Evidence status | Safety and efficacy are being evaluated; results are not yet established | Well‑studied in EBV‑positive lymphoma subtypes with established response rates in clinical practice |
| Important risks | Risks related to infusion reactions, lymphodepletion toxicity, or T‑cell therapy side effects require evaluation | Known chemotherapy‑related toxicities such as cytopenias, infection risk, organ toxicity, neuropathy |
| Important limitations | Single‑group design without comparator limits efficacy interpretation; dose‑escalation adds complexity and may delay access | Less effective or more toxic in patients who relapse after chemotherapy or who are unfit for multi‑agent regimens |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 weeks for initial treatment and monitoring
Participants receive an infusion of C7R-EBV T cells, with some also receiving chemotherapy medicines beforehand to prepare the body. The infusion lasts 1 to 10 minutes, followed by about 2 hours of monitoring. Some may receive a second infusion at least 6 weeks later if needed.
Initial infusion day visit and monitoring; stay in Houston for up to 2 weeks post-infusion
Duration - Up to 15 years
Participants have scheduled follow-up visits for physical exams, blood tests, and imaging to assess the treatment effect and safety. Visits occur weeks 1, 2, 4, 6; months 3, 6, 9, 12; and annually for up to 15 years.
Multiple scheduled visits including weeks 1, 2, 4, 6; months 3, 6, 9, 12; and annual visits thereafter
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Sandhya Sharma, Tim Sauer, Bilal A Omer...
https://pubmed.ncbi.nlm.nih.gov/37958791/Sandhya Sharma, Naren U Mehta, Tim Sauer...
https://pubmed.ncbi.nlm.nih.gov/38640255/Baylor College of Medicine
Lead Sponsor
The Methodist Hospital Research Institute
Collaborating Sponsor