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

A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).

This study is testing if TQ05105 tablets can help improve symptoms and overall health in adults with moderate-to-severe chronic graft-versus-host disease after a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 12 sites (Hefei, Anhui and 11 other locations)
• Trial ID: NCT06300320 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with moderate-to-severe chronic graft-versus-host disease who have received allogeneic stem cell transplants.

Not a fit: Patients with active acute graft-versus-host disease or other malignancies within the last three years may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients with chronic graft-versus-host disease.

How similar studies have performed: While there have been studies on treatments for cGVHD, the specific use of TQ05105 tablets represents a novel approach.

Eligibility criteria

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 this trial is running

Hefei, Anhui and 11 other locations

• 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)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
• Tai'an Central Hospital — Taian, Shangdong, China (Not_yet_recruiting)
• Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shannxi, China (Not_yet_recruiting)
• Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• The Affiliated People's Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: He Huang, PhD

Conditions Chronic Graft Versus Host Disease