Donor immune cells show promise against Virus-Linked cancers
NCT ID NCT02287311
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment for cancers linked to the Epstein-Barr virus (EBV), such as Hodgkin lymphoma and nasopharyngeal carcinoma. The treatment uses immune cells from healthy donors that are specially trained to attack EBV-infected cells. These cells are stored in a bank and given to patients who have not responded to standard treatments. The main goal is to check if the cells are safe and to see if they can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MABEL CTLs (immune cells from healthy donors trained to attack EBV-infected cells)
- What this could lead to
- If this works, it could offer a faster, off-the-shelf treatment option for patients with EBV-positive cancers that have not responded to standard therapies.
- What could go wrong
- This is an early phase 1 trial with only 38 participants, so it is too soon to know if the treatment is effective. There is also a risk of side effects like immune reactions or the cells not lasting long enough.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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38 people
The number who actually took part.
- Start date
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Feb 2015
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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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: SCREENING 1. Any patient regardless of age or sex, with diagnosis of either: * EBV positive Hodgkin's lymphoma * EBV Positive non-Hodgkin's Lymphoma (regardless of histologic subtype) * EBV (associated)-T/NK-lymphoproliferative disease * Severe Chronic Active EBV (CAEBV) -- 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 * Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.) AND * in first or subsequent relapse (Group A) * with active disease persisting despite therapy (Group B) * with active disease 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 C) 2. EBV positive tumor 3. Weighs at least 12kg 4. Informed consent (and assent as applicable) obtained from patient/guardian. TREATMENT 1. Any patient regardless of age or sex, with diagnosis of either: * EBV positive Hodgkin's lymphoma * EBV Positive non-Hodgkin's Lymphoma (regardless of histologic subtype) * EBV (associated)-T/NK-lymphoproliferative disease * Severe Chronic Active EBV (CAEBV) -- 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 * Other EBV positive malignancies (e.g. nasopharyngeal carcinoma, smooth muscle tumors, etc.) AND * in first or subsequent relapse (Group A) * with active disease persist despite therapy (Group B) * with active disease 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 C) 2. EBV positive tumor 3. Patients with life expectancy greater than or equal to 6 weeks 4. Patients with bilirubin less than or equal to 3x upper limit of normal 5. AST less than or equal to 5x upper limit of normal 6. Hemoglobin greater than or equal to 7.0 (may be a transfused value) 7. Patients with a creatinine less than or equal to 2x upper limit of normal for age 8. Pulse oximetry of \> 90% on room air 9. Patients should have been off other investigational therapy for 30 days prior to infusion. 10. Patients with a Karnofsky/Lansky score of more than or equal to 50. 11. 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. The male partner should use a condom. 12. Informed consent (and assent as applicable) obtained from patient/guardian. Exclusion Criteria: TREATMENT 1. Pregnant or lactating 2. Severe intercurrent infection 3. Current use of systemic corticosteroids more than 0.5 mg/kg/day 4. Patients receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days.
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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.
Contacts and locations
Locations
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Houston Methodist Hospital
Houston, Texas, 77030, United States
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Texas Children's Hospital
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can zapping liver and lung tumors boost treatment for nasopharyngeal cancer?
- Double-Drug attack on Hard-to-Treat lymphomas
- Patient's own t cells engineered to hunt lymphoma in early trial
- Can a dual immune antibody plus radiation shrink metastatic sarcoma?
- Immunotherapy injection tested against Hard-to-Treat childhood lymphoma
- Vaccine aims to train immune system against blood cancers