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New hope for rare immune disease: drug combo shows promise in small study

NCT ID NCT07531069

Disease control Sponsor: Fudan University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a combination of two drugs—interferon-gamma monoclonal antibody and dexamethasone—in 22 adults with a severe immune condition called refractory secondary HLH. The goal was to see if the treatment helps patients recover and how safe it is. Participants received the drugs as part of their care and were monitored with blood tests and checkups for 8 weeks.

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.

Participants

22 people

The number who actually took part.

Started

May 2024

Finished

Aug 2025

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.

Who is studied

This study will enroll adult participants aged 18 years and older with a confirmed diagnosis of refractory secondary hemophagocytic lymphohistiocytosis (HLH) based on the HLH-2004 diagnostic criteria. Participants must have demonstrated inadequate response or disease progression following standard first-line or second-line HLH-directed therapy. All participants must be able to provide written informed consent prior to any study-related procedures.

Ages

18 years and older

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: * Age ≥ 18 years * Confirmed diagnosis of secondary hemophagocytic lymphohistiocytosis (HLH) according to HLH-2004 criteria * Refractory HLH defined as inadequate response or progression after at least 2 weeks of standard first-line or second-line therapy * Able to provide written informed consent Exclusion Criteria: * Active infection with mycobacteria, histoplasma, CMV, herpes zoster, or HIV * Left ventricular ejection fraction \< 50% * Concurrent use of other anti-neoplastic or investigational agents * Other uncontrolled infections judged by the investigator * Psychiatric disorders or poor protocol compliance

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Conditions

The condition(s) this trial relates to.

hemophagocytic syndrome secondary hemophagocytic lymphohistiocytosis

As listed by the trial registrant

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

Adult refractory secondary hemophagocytic lymphohistiocytosis HLH Secondary hemophagocytic lymphohistiocytosis

Contacts and locations

Locations

  • Huadong Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040, China

More trials for these conditions

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