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New antibody cocktail targets stubborn liver disease after stem cell transplants

NCT ID NCT06364319

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a lab-made antibody called anti-CD25 rhMAb for people with chronic graft-versus-host disease (cGVHD) of the liver that hasn't improved with steroids. The antibody is given alongside standard immune-suppressing drugs. The trial will include 30 adults aged 16-65 who have had a stem cell transplant. The goal is to see if this combination can shrink liver damage and control the disease better than current options.

What this could mean

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

Active substance
anti-CD25 rhMAb (a lab-made antibody) combined with prednisone, ruxolitinib, and cyclosporine
What this could lead to
If it works, this could offer a new treatment option for people with severe liver graft-versus-host disease that hasn't responded to steroids.
What could go wrong
This is a small, early-phase trial with only 30 people, so results may not apply to everyone. The treatment also requires ongoing immune-suppressing drugs, which carry risks of infection and other side effects.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 30 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 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

16 to 65 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: 1. Age 16 and 65 years 2. Received allogeneic hematopoietic stem cell transplantation 3. Developed chronic GVHD in the liver after transplantation 4. Ineffective prednisone treatment prior to screening 5. Received ≤4 lines of systemic therapy prior to screening 6. After informed consent, the patient agreed to receive anti-CD25 rhMAb treatment Exclusion Criteria: 1. Elevation of bilirubin, ALT, or alkaline phosphatase due to reasons other than chronic GVHD 2. No prior treatment with prednisone 3. Overlap syndrome 4. Uncontrolled active infection 5. Organ failure 6. Early progression or recurrence of hematologic diseases 7. Allergy to anti-CD25 rhMAb 8. Received other interleukin-2 receptor monoclonal antibody treatment due to various reasons within one month after transplantation 9. Participated in other clinical studies within one month

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Conditions

The condition(s) this trial relates to.

chronic graft versus host disease

As listed by the trial registrant

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

CGVHD

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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