Treatment of chronic graft-versus-host disease with TQ05105 tablets

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of TQ05105 tablets in patients suffering from chronic graft-versus-host disease (cGVHD). It is an open, multi-center study that includes participants aged 18 to 70 who have undergone allogeneic hematopoietic stem cell transplantation and have moderate-to-severe cGVHD. Eligible patients must have stable doses of glucocorticoids and meet specific hematological criteria. The study aims to determine how well TQ05105 can improve symptoms and overall health in these patients.

Why it matters

Who can join: the full rules

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;

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• The 940th hospital of joint logistics support force of Chinese people's liberation army
  Lanzhou, Gansu, China Not yet recruiting
• Guangzhou First People's Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Not yet recruiting
• The Second Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Not yet recruiting

Study contacts

• Study coordinator: He Huang, PhD
• Email: hehuangyu@126.com
• Phone: 13605714822

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belumosudil vs Best Available Therapy for chronic graft-versus-host disease

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• Mindfulness program to help with symptoms in chronic graft-versus-host disease

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• Madecassoside tablets plus standard therapy for sclered scl-cGVHD after allo-HSCT

  This study tests whether adding madecassoside tablets to standard therapy can help people with scleral chronic graft-versus-host disease after stem cell transplant.

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• Post-transplant dental cleaning to prevent chronic graft-versus-host disease

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• Adrixetinib (Q702) for adults with active chronic graft-versus-host disease.

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  Recruiting at 8 sites Phase 1 Qurient Co., Ltd. · Barcelona and 7 other locations · NCT07138196

• How whole versus crushed belumosudil tablets behave in people with chronic GVHD

  This will test whether taking belumosudil as whole tablets or crushed tablets suspended in water changes how the drug is absorbed in adults with chronic graft-versus-host disease.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.