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Can a cell injection calm the gut after a stem cell transplant?

NCT ID NCT07803978

Disease control Sponsor: Chinese PLA General 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether adding an experimental cell therapy called Amimaitosai to standard steroids can treat severe gut inflammation that sometimes occurs after a stem cell transplant. The study enrolls people with blood cancers who develop this condition, called gastrointestinal graft-versus-host disease. Participants receive either the cell therapy plus a lower steroid dose or a higher steroid dose alone. Researchers measure how many people improve within 28 days and track longer-term outcomes like relapse and survival.

What this could mean

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

Active substance
Amimaitosai injection combined with methylprednisolone (a corticosteroid)
What this could lead to
If it works, this combination could offer a new first-line treatment for a serious complication of stem cell transplants, potentially improving recovery and survival.
What could go wrong
This is an early-phase trial with only 60 participants, so results may not hold up in larger studies. The treatment may not improve outcomes and could carry risks like infection or 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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 60 people

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

Started

May 2026

Expected to finish

May 2029

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 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: * Malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and CML in chronic phase * Availability of HLA-matched sibling donors, unrelated donors, or haploidentical donors * Age 14 years and older * Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal * Kidney function: creatinine ≤ upper limit of normal * No uncontrolled infections or severe psychiatric disorders * Performance status 0-2 (ECOG) * Signed informed consent * Patients with acute gastrointestinal GVHD after transplantation (according to MAGIC criteria) Exclusion Criteria: * No suitable allogeneic donor * Non-gastrointestinal GVHD as the main manifestation * Either donor or recipient is pregnant * Psychiatric illness or other conditions preventing protocol compliance

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease

As listed by the trial registrant

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

Acute gastrointestinal graft-versus-host disease

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

    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 ↗

  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

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

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