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Can a targeted pill tame a rare immune disease?

NCT ID NCT07728201

Disease control Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This phase 2 trial is testing whether the experimental drug luvometinib, taken alone or with the chemotherapy drug cytarabine, can control Langerhans cell histiocytosis—a rare disease where immune cells build up and damage tissues. People aged 10 and older who need systemic treatment will receive luvometinib for six cycles. If their disease responds well, they continue on luvometinib alone; if not, they may also get cytarabine. The study aims to see how many participants achieve a significant reduction in disease activity.

What this could mean

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

Active substance
luvometinib, an experimental drug taken orally, sometimes combined with the chemotherapy drug cytarabine
What this could lead to
If successful, this could offer a new targeted treatment option for people with Langerhans cell histiocytosis, potentially reducing the need for more aggressive therapies.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. Side effects from luvometinib and cytarabine are possible, and the treatment may not work for everyone.

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 30 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2030

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

10 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: * Histologically confirmed Langerhans cell histiocytosis (LCH). * Age 10 years or older. * Systemic treatment indication and at least one PET response criteria-evaluable lesion. * Expected survival of at least 12 weeks, as judged by the investigator, and able to undergo protocol-specified treatment, assessments, and follow-up. * ECOG performance status 0-2 or Lansky score \>=60. * Adequate organ function as defined in the protocol. * Written informed consent from adult participants or legal guardians, with participant assent when applicable. Exclusion Criteria: * Hypersensitivity to luvometinib or any excipient. * Concurrent other malignant tumor. * Pregnancy or breastfeeding. * Failure to meet protocol contraception requirements. * Active bacterial, fungal, or viral infection. * Significant retinal disease or glaucoma. * NYHA class \>=3 heart failure or LVEF \<50%. * Psychiatric disease or other condition preventing protocol compliance. * Investigator judgment that participation is unsuitable.

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Conditions

The condition(s) this trial relates to.

Histiocytosis, Langerhans-Cell Langerhans cell histiocytosis

As listed by the trial registrant

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

Langerhans cell histiocytosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. 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

  • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

More trials for these conditions

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