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New pill shows promise for Hard-to-Treat transplant complication

NCT ID NCT04944043

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new tablet called TQ05105 in 45 adults with moderate to severe chronic graft-versus-host disease (cGVHD) that hasn't responded to steroids. The drug works by blocking a protein pathway involved in inflammation. The goal is to find the right dose and see if it can control the disease, potentially reducing the need for steroids.

What this could mean

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

Active substance
TQ05105 tablet (a JAK inhibitor)
What this could lead to
If successful, this could offer a new treatment option for people with chronic graft-versus-host disease that doesn't respond to steroids, helping control the condition and reduce steroid dependence.
What could go wrong
This is an early-phase trial with only 45 participants, so results may not apply to everyone. 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

45 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Dec 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: * Understood and signed an informed consent form. * ≥18 years old, Karnofsky Performance Scale of ≥60, life expectancy ≥ 6 months. * Has received allogeneic hematopoietic stem cell transplantation (alloSCT). * Clinically diagnosed moderate to severe cGVHD according to NIH Consensus Criteria. * Has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cGVHD according to NIH Consensus Criteria. * Has received at least 1 lines of therapy for cGVHD. * Adequate laboratory indicators. * No pregnant or breastfeeding women, and a negative pregnancy test. Exclusion Criteria: * Has active acute GVHD. * Has previously failed to respond to JAK inhibitors for GVHD, or who had used JAK inhibitors within 4 weeks before the first administration. * Has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration. * Development of other basic diseases. * Has malignant tumors within 3 years. * Has multiple factors affecting oral medication. * Has substance abuse or a psychotic disorder. * Has severe and / or uncontrolled disease. * Allergic to drugs or its constituents. * Has participated in any other clinical trials within 4 weeks before first administration. * According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

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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.

Chronic graft versus host disease

Contacts and locations

Locations

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 511457, China

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin Municipality, 300020, China

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310000, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000, China

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, 430030, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280, China

More trials for these conditions

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