Cord blood transplant offers new hope for rare EBV diseases
NCT ID NCT07381738
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a transplant of donated umbilical cord blood can help people aged 14 to 80 with serious diseases caused by the Epstein-Barr virus (EBV), such as certain lymphomas or chronic active EBV infection. The goal is to control the disease and improve survival, but lifelong monitoring or additional treatment may still be needed. About 80 participants will receive the transplant and be followed for side effects and response.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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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14 to 80 years
- 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:General Inclusion Criteria: All subjects must meet all of the following criteria: Age range: 14 to 80 years old, inclusive. Diagnosed with an EBV-associated lymphoproliferative disease (including Chronic Active EBV Infection, EBV-associated Hemophagocytic Lymphohistiocytosis, and EBV-associated Lymphoma). Meet at least one of the following disease-specific criteria (see below). ECOG Performance Status score of 0-2 (or Lansky Play-Performance score ≥60 for children). Expected survival of ≥3 months. Signed informed consent form (for minors, consent must be provided by a legal guardian). Disease-Specific Inclusion Criteria: A. CAEBV Patients: Patients diagnosed with CAEBV according to the 2016 revised WHO classification criteria, who also meet all of the following: * Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months. * Elevated EBV-DNA load in peripheral blood or involved tissues (peripheral blood EBV-DNA \> 500 copies/ml). * Detection of EBV in T or NK cells (via EBER in situ hybridization or LMP1 immunohistochemistry). * Exclusion of other known immunodeficiency disorders, autoimmune diseases, or neoplastic diseases. B. EBV-HLH Patients: Meet ≥5 of the HLH-2004 diagnostic criteria: * Persistent or recurrent infectious mononucleosis-like symptoms for more than 3 months. * Fever ≥38.5°C. * Splenomegaly. * Cytopenias (affecting ≥2 of 3 lineages): * Hb \<90 g/L * PLT \<100 × 10⁹/L * ANC \<1.0 × 10⁹/L * Hypertriglyceridemia (\>3 mmol/L) and/or hypofibrinogenemia (\<1.5 g/L). * Serum ferritin \>500 μg/L. * sCD25 \>2400 U/mL. * Decreased or absent NK cell activity. * Evidence of hemophagocytosis in bone marrow, spleen, or lymph nodes. C. EBV-associated Lymphoma Patients: * Pathologically confirmed diagnosis according to WHO criteria. * EBV-positive (EBER+). * Failure of or relapse after first-line therapy. Exclusion Criteria:Patients meeting any of the following criteria will be excluded: History of another primary malignancy within 5 years prior to the first treatment. Uncorrected thyroid dysfunction. Grade II or higher cardiac disease according to the New York Heart Association (NYHA) classification. History of organ transplantation. Planned to receive other types of hematopoietic stem cell transplantation during the study period. Active infections, including: Active hepatitis B or hepatitis C. Positive serum HIV antigen or antibody. History of syphilis. Major surgery within 4 weeks prior to the first treatment, or anticipated need for major surgery during the study. Pregnant or breastfeeding women. History of severe psychiatric illness or substance abuse. High risk of complications, such as: Uncontrolled infection. Active major visceral hemorrhage. Known allergy to any component of the investigational drug(s), or a history of severe allergies. Patients deemed unable to comply with the study procedures and/or follow-up requirements. \-
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Huadong hospital, Fudan university
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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Huashan Hospital, Fudan University
RECRUITINGShanghai, Shanghai Municipality, 200040, China
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