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Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm

NCT ID NCT05775705

Disease control Sponsor: Beijing Friendship Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers are testing a combination of L-DEP chemotherapy (aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) and a PD-1 antibody as initial treatment for people with Epstein-Barr virus-positive lymphoma-associated hemophagocytic lymphohistiocytosis, a rare and aggressive immune condition. The trial enrolls up to 24 adults aged 18 to 70 who have this diagnosis and signs of active EBV infection. The main goal is to see how many participants respond to the treatment, with secondary measures tracking EBV clearance, overall survival, and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
L-DEP regimen (aspargase, liposomal doxorubicin, etoposide, and methylprednisolone) combined with a PD-1 antibody
What this could lead to
If it works, this combination could offer a way to bring this rare, aggressive immune condition under control and clear EBV from the blood.
What could go wrong
This is a small, early-phase study with no control group, so any benefit is hard to separate from standard care. The chemotherapy is intense and can cause serious side effects, and the condition itself is often life-threatening.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Aug 2023

Finished

Aug 2026

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

18 to 70 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: * Diagnosed as lymphoma-Hemophagocytic Lymphohistiocytosis. * EBV-DNA in peripheral blood \> 1000 copies/ml or EBER detected in tissue specimens. * Age 18\~70，gender is not limited. * Estimated survival time ≥ 1 month. * Cardiac ultrasound LVEF≥50%; No Active bleeding of the internal organs(digestive tract, lung, brain, etc.); If the patient has dyspnea, oxygenation index \>250. * Signed informed consent. Exclusion Criteria: * Heart function above grade II (NYHA). * Severe myocardial injury：TNT、TNI、CK-MB \> 3 ULN. * Accumulated dose of doxorubicin above 400mg/m2 、epirubicin above 750mg/m2、pirarubicin above 800mg/m2 or the patients treated with anthracycline induced cardiovascular disease. * Pregnancy or lactating Women. * Allergic to pegylated liposomal doxorubicin，etoposide，or PD-1 antibody. * Thyroid dysfunction. * HIV antibody positivity. * Acute or chronic active hepatitis B (HBsAg positivity, HBV DNA negative acceptable), acute or chronic active hepatitis C (HCV antibody negatively acceptable; HCV antibody positivity, HCV RNA negative acceptable). * Participate in other clinical research at the same time. * The researchers considered that patients are not suitable for the study.

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Conditions

The condition(s) this trial relates to.

Epstein-Barr virus infection hemophagocytic syndrome Lymphohistiocytosis, Hemophagocytic lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epstein-Barr virus Hemophagocytic lymphohistiocytosis Lymphoma PD-1 antibody

Contacts and locations

Locations

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

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