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New pill tested for severe transplant complication

NCT ID NCT04941404

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 tested a new drug, TQ05105, in 13 people who had severe graft-versus-host disease (aGVHD) after a stem cell transplant and did not respond to steroids. The goal was to see if the drug is safe and can help control the disease. The study was stopped early, so results are limited.

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

13 people

The number who actually took part.

Started

Jun 2022

Finished

Dec 2024

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

12 to 75 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. Subjects voluntarily participated in the study and signed an informed consent, with good compliance. 2. Aged 12-75, gender is not limited. 3. Subjects who has received allogeneic hematopoietic stem cell transplantation (allo-HSCT) previously. 4. Clinically suspected grades II to IV acute GVHD as per MAGIC guidelines. 5. Drug resistance after glucocorticoid treatment. 6. Absolute neutrophils count (ANC) \>1×109/L,Platelet(PLT)≥20×109/L within 48 hours before initial treatment. 7. Male or female subjects should agree use an adequate method of contraception during the study and within 6 months after the end of the study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration. Exclusion Criteria: 1. Subjects with a history of progressive multifocal leukoencephalopathy. 2. Subjects with many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.). 3. Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, etc.. 4. Severe respiratory diseases (requiring mechanical ventilation or O2 saturation \< 90%), active tuberculosis, pulmonary hypertension and pulmonary embolism, etc.. 5. Subjects with a history of psychotropic drug abuse and can not quit or have mental disorders. 6. Subjects with any severe and/or uncontrolled disease, including: (1) Unsatisfactory blood pressure control with more than 2 drugs (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥ 100mmHg) ; (2) Patients with grade ≥2 myocardial ischemia or infarction, arrhythmias (including QTc≥480ms), and grade ≥2 congestive heart failure (New York Heart Association classification); (3) Uncontrolled active infections including bacteria, fungi, parasites or viruses such ascytomegalovirus, Epstein-Barr virus, and human herpes virus 6; (4) Cirrhosis, active hepatitis; (5) Human immunodeficiency virus(HIV) positive, active syphilis; (6) Creatinine clearance rate \< 30 mL/min,calculated by Cockcroft Gault formula; (7) Patients with epilepsy and need treatment. 7. Subjects with evidence of recurrence of primary disease or relapsed after allo-HSCT treatment. 8\. There were grade 2 or higher toxicity (except aGVHD) caused by previous allo HSCT treatment. 9\. Subjects who received allo-HSCT more than once in the past. 10. Subjects who received more than one kind of systemic treatment for Glucocorticoid-Refractory aGVHD. 11\. The clinical manifestations were new-onset chronic GVHD or overlapping GVHD syndrome with both acute and chronic GVHD features. 12\. Allergic to the investigational drug or its ingredients. 13. Subjects who used Janus kinase inhibitor (JAK) therapy after receiving Allo-HSCT. 14\. Subjects who participated in other clinical trials within 4 weeks before initial administration. 15\. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are considered unsuitable for other reasons.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Hematology Hospital of the chinese Academy of Medical Sciences

    Tianjing, Tianjing, 300020, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215008, China

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310012, China