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New pill AC-003 tested for severe transplant complication

NCT ID NCT07070674

Disease control Sponsor: Accro Bioscience (Suzhou) Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing an experimental drug called AC-003 in 24 adults who have acute graft-versus-host disease (aGVHD) after a stem cell transplant and whose condition has not improved with steroids. The study aims to see if the drug is safe and tolerable, and to get an early look at whether it might help control the disease. Participants will take AC-003 capsules by mouth, and researchers will monitor side effects and any signs of improvement.

What this could mean

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

Active substance
AC-003 capsules
What this could lead to
If successful, this could point toward a new treatment option for patients with acute graft-versus-host disease that does not respond to steroids.
What could go wrong
This is a very early, small Phase Ib trial with only 24 participants, so results may not confirm safety or effectiveness. The drug may cause side effects or fail to improve outcomes.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

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

Started

Jul 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: 1. Male or female patients age ≥ 18 years. 2. Patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) from any donor source (including matched unrelated donor, haplo-identical). 3. Diagnosis of grade II-IV aGVHD as per MAGIC criteria within 100 days after HSCT. 4. Diagnosis of steroid-refractory or steroid-dependent aGVHD in at least one of the following criteria: 1. Progressive Disease, defined as any target organ worsening, after 3 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 2. Not partial response after 7 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 3. Not complete response after 14 days of initial treatment with methylprednisolone 1\~2 mg/kg/day (or equivalent corticosteroid) 4. Relapse of aGVHD when corticosteroid tapering. Exclusion Criteria: 1. Evidence of aGVHD relapsed. 2. Evidence of chronic GVHD or overlap syndrome 3. Receipt of more than one allogeneic HSCT 4. Receipt of more than one systemic treatment for aGVHD in addition to corticosteroid 5. Any corticosteroid therapy for indications other than aGvHD at doses \>= 1 mg/kg/day methylprednisolone (or equivalent corticosteroid) within 7 days prior to enrolment 6. Severe organ dysfunction unrelated to aGVHD 7. Uncontrolled active infection (i.e., bacterial, fungal, or viral)

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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-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

    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

  • Hematology Hospital of Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences)

    RECRUITING

    Tianjin, Tianjin Municipality, China

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