TQ05105 Tablet: TQ05105 tablet is a Janus Kinase (JAK) inhibitor, which can inhibit the abnormal activation of JAK 2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK / STAT pathway.
Study summary
This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Maximal Tolerable Dose (MTD) — Baseline up to 4 weeks If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. (Patients in phase Ib)
Recommended phase II dose (RP2D) — Baseline up to 4 weeks Recommended dose for phase II (Patients in phase Ib)
Best Overall Response Rate (BOR) — Baseline up to 96 weeks Percentage of participants achieving complete response (CR) and partial response (PR). (Patients in phase II)
Trial sites (12)
Facility
City
Region
Status
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei
Anhui
Zhujiang Hospital of Southern Medical University
Guangzhou
Guangdong
Nanfang Hospital of Southern Medical University
Guangzhou
Guangdong
Guangzhou First People's Hospital
Guangzhou
Guangdong
The First Affiliated Hospital of Guangxi Medical University
Nanning
Guangxi
The Second Hospital of Hebei Medical University
Shijiazhuang
Hebei
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Henan
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
Tongji Hospital Tongji Medical College of HUST
Wuhan
Hubei
The First Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin
Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou
Zhejiang
More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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