New immune cells take aim at Virus-Linked lymphomas
NCT ID NCT01555892
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new way to make immune cells (called GRALE T cells) that are trained to attack cells infected with the Epstein-Barr virus (EBV), which is linked to some lymphomas. The trial includes people with Hodgkin or non-Hodgkin lymphoma, or related diseases, whose cancer has returned or not gone away. The goal is to find a safe dose and see if these cells can survive in the body and fight the tumor.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GRALE T cells (immune cells trained to attack EBV-infected cells)
- What this could lead to
- If it works, this could offer a new treatment option for patients with EBV-related lymphomas that have not responded to standard therapy.
- What could go wrong
- This is an early phase 1 trial, so the main goal is safety, not yet proof of effectiveness. The treatment is experimental and may not shrink tumors or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 136 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2013
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria at time of Procurement 1. 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 or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component 2. EBV positive tumor (can be pending at this time) 3. Weighs at least 12kg 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Inclusion Criteria at time of Infusion 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\* and In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)\*\* OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A) OR In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B) 2. EBV positive tumor 3. Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value). 4. Patients with a creatinine less than or equal to 2x upper limit of normal for age 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. PD1/PDL inhibitors will be allowed if medically indicated. 7. Patients with a Karnofsky/Lansky score of greater than or equal to 50 8. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. 9. Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent. * CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV * Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant. Exclusion Criteria at Time of Procurement 1\. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time) Exclusion Criteria at Time of Infusion 1. Pregnant or lactating 2. Severe intercurrent infection. 3. Current use of systemic corticosteroids \> 0.5 mg/kg/day
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for EBV-associated T/NK-lymphoproliferative disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
3 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Harris Health System (includes ben Taub General Hospital and Smith)
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
-
Houston Methodist Hospital
RECRUITINGHouston, Texas, 77030, United States
-
Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Off-the-Shelf Gene-Edited immune cells tested against Hard-to-Treat lymphoma
- Can a calming drug make cord blood transplants safer?
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- Do social factors decide who completes lymphoma treatment?