A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease
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ClinicalTrials.gov Identifier: NCT04944043 |
Recruitment Status :
Active, not recruiting
First Posted : June 29, 2021
Last Update Posted : July 27, 2023
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Condition or disease | Intervention/treatment | Phase |
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Chronic Graft Versus Host Disease | Drug: TQ05105 Tablet | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Group, Open-Label, Multicenter ,Phase Ib/II Clinical Trials of TQ05105 Tablet in Patients With Glucocorticoid Refractory and Dependent Moderate to Severe Chronic Graft Versus Host Disease (cGVHD). |
Actual Study Start Date : | June 25, 2021 |
Actual Primary Completion Date : | June 30, 2023 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
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Experimental: TQ05105 Tablet
TQ05105 tablet 10mg given orally, twice daily in 28-cycle.
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Drug: 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. |
- Maximal Tolerable Dose (MTD) [ Time Frame: 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) [ Time Frame: Baseline up to 4 weeks ]Recommended dose for phase II (Patients in phase Ib)
- Best Overall Response Rate (BOR) [ Time Frame: Baseline up to 96 weeks ]Percentage of participants achieving complete response (CR) and partial response (PR). (Patients in phase II)
- Overall Response Rate (ORR) [ Time Frame: Baseline up to 52 weeks ]Percentage of participants achieving complete response (CR) and partial response (PR) during the study according to the cGVHD NIH Consensus Criteria.
- Duration of Response (DOR) [ Time Frame: Baseline up to 96 weeks ]DOR defined as time from earliest date of disease response to earliest date of disease progression.
- Overall survival (OS) [ Time Frame: Baseline up to death event, up to 5 years. ]OS defined as the time from randomization to the time of death from any cause.
- Non-relapse mortality (NRM) [ Time Frame: Baseline up to 96 weeks ]Defined as the date of first dose to the date of death from non hematologic disease recurrence / progression
- Failure Free Survival (FFS) [ Time Frame: Baseline up to 12 months ]Defined as absence of relapse, death, or need for additional systemic immunosuppressant cGVHD therapy.
- Changes in glucocorticoid dose [ Time Frame: Baseline up to 96 weeks ]The reduction in glucocorticoid requirement would be regarded as an effect of the trial drug.
- Changes in symptom burden [ Time Frame: Baseline up to 96 weeks ]Evaluate changes in symptom burden as measured by the Lee Symptom Scale. A change of 7 points on the Lee Symptom Scale will be considered clinically significant and relates to improvement in quality of life.
- Maximum plasma concentration (Cmax) [ Time Frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. ]Cmax is the maximum plasma concentration of TQ05105 or its metabolite(s).
- Time to reach maximum plasma concentration (Tmax) [ Time Frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. ]To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration.
- Area under the plasma concentration time curve (AUC0-t) [ Time Frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7. ]To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity.
- Incidence rate of adverse event [ Time Frame: Baseline up to 96 weeks. ]The occurrence rate of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) assessed based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944043
China, Anhui | |
The First Affiliated Hospital of USTC (Anhui Provincial Hospital) | |
Hefei, Anhui, China, 230001 | |
China, Guangdong | |
Zhujiang Hospital of Southern Medical University | |
Guangzhou, Guangdong, China, 510280 | |
Nanfang Hospital of Southern Medical University | |
Guangzhou, Guangdong, China, 510515 | |
Guangzhou First People's Hospital | |
Guangzhou, Guangdong, China, 511457 | |
China, Guangxi | |
The First Affiliated Hospital of Guangxi Medical University | |
Nanning, Guangxi, China, 530021 | |
China, Hebei | |
The Second Hospital of Hebei Medical University | |
Shijiazhuang, Hebei, China, 050000 | |
China, Henan | |
The First Affiliated Hospital of Zhengzhou University | |
Zhengzhou, Henan, China, 450052 | |
China, Hubei | |
Union Hospital Tongji Medical College Huazhong University of Science and Technology | |
Wuhan, Hubei, China, 430022 | |
Tongji Hospital Tongji Medical College of HUST | |
Wuhan, Hubei, China, 430030 | |
China, Jiangsu | |
The First Affiliated Hospital of Soochow University | |
Suzhou, Jiangsu, China, 215006 | |
China, Tianjin | |
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | |
Tianjin, Tianjin, China, 300020 | |
China, Zhejiang | |
The First Affiliated Hospital, Zhejiang University School of Medicine | |
Hanzhou, Zhejiang, China, 310000 |
Responsible Party: | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT04944043 |
Other Study ID Numbers: |
TQ05105-Ib/II-02 |
First Posted: | June 29, 2021 Key Record Dates |
Last Update Posted: | July 27, 2023 |
Last Verified: | July 2023 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Bronchiolitis Obliterans Syndrome Graft vs Host Disease Immune System Diseases Organizing Pneumonia Bronchiolitis Obliterans Bronchiolitis |
Bronchitis Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |