Can a new pill tame the immune System's attack after stem cell transplants?

NCT ID NCT06300320

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This phase II trial is testing an oral medication called rovadicitinib in adults with moderate to severe chronic graft-versus-host disease (cGVHD), a condition where donor immune cells attack the recipient's body after a stem cell transplant. The drug aims to reduce both inflammation and fibrosis, which are key drivers of cGVHD. The study will measure how many patients achieve a meaningful response after 24 weeks of treatment, as well as the duration of that response.

What this could mean

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

Active substance
Rovadicitinib (TQ05105), an oral dual JAK 1/2 and ROCK 1/2 inhibitor
What this could lead to
If successful, this could offer a new oral treatment option for patients with chronic graft-versus-host disease who have not responded to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so results may not be conclusive. The drug may cause side effects or may not improve outcomes for all patients.

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 65 people

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

Started

May 2024

Expected to finish

May 2029

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 to 70 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: * Voluntary and signed informed consent, good compliance; * Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months. * Received allogeneic hematopoietic stem cell transplantation; * Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD) * Received systemic therapies for cGVHD; * Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; * Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ;platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function; * Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study Exclusion Criteria: * Currently present or occured other malignancies within 3 years prior to first administration; * Known or suspected active acute graft versus host disease (aGVHD); * Presence of infection requiring treatment within 7 days prior to randomization; * Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; * Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; * Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc; * Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; * Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; * Have any severe or uncontrolled serious illness, including but not limited to,uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; * Those who are allergic to the study drug or its components; * Participation in other clinical trials or major surgery within 4 weeks prior to the first dose; * Subjects judged by the investigator to be unsuitable for enrollment;

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic graft versus host disease

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    12 sites. 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

  • Anhui Provincial Hospital

    NOT_YET_RECRUITING

    Hefei, Anhui, 230001, China

  • Guangzhou First People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510180, China

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Tai'an Central Hospital

    NOT_YET_RECRUITING

    Taian, Shangdong, China

  • The 940th hospital of joint logistics support force of Chinese people's liberation army

    NOT_YET_RECRUITING

    Lanzhou, Gansu, 730050, China

  • The Affiliated People's Hospital of Ningbo University

    NOT_YET_RECRUITING

    Ningbo, Zhejiang, 315040, China

  • The First Affiliated Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    NOT_YET_RECRUITING

    Xi'an, Shannxi, 710299, China

  • The Second Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, 050000, China

  • Xiangyang Central Hospital

    NOT_YET_RECRUITING

    Xiangyang, Hubei, 441021, China

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