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Cord blood transplant offers new hope for rare EBV diseases

NCT ID NCT07381738

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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

14 to 80 years

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Huadong hospital, Fudan university

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Huashan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

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Other studies related to the condition(s) this trial covers.