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This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
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This is an open-label,single arm,Phase Ib study,in order to evaluate the safety,tolerability, preliminary efficacy and pharmacokinetics of TQ05105 tablets in subjects with Glucocorticoid-Refractory aGVHD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ05105 tablets | Experimental | Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ05105 tablets | Drug | Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug tolerance of the first cycle (Stage 1) | Dose-limiting toxicity events related to the investigational drug occured within 28 days after initial administration | Day 28 after initial administration |
| Objective Response Rate (ORR) at Day 28 (Stage 2) | Percentage of subjects with complete response (CR) or very good partial response (VGPR) or partial response (PR) at Day 28 | Day 28 after initial administration |
| Measure | Description | Time Frame |
|---|---|---|
| CR Rate at Day 28 | Percentage of subjects with CR at Day 28 | Day 28 after initial administration |
| ORR at Day 28 and Day 56 | Percentage of subjects with CR or VGPR or PR at Day 28 and Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
(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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530021 | China | ||
| The First Affiliated Hospital of Soochow University |
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| Day 28 and Day 56 after initial administration |
| Duration of Response (DOR) | From date of first recorded remission to date of first recorded disease progression or date of starting any new systemic therapy for aGVHD | From initial administration to day 30 after the last administration |
| Cumulative dose of glucocorticoid at Day 56 | Totally and weekly cumulative dose of glucocorticoid of each subject,from initial administration to Day 56 or the day end of therapy | Day 56 after initial administration |
| Event Free Survival (EFS） | From the date of initial administration to the date of recurrence/progression of hematological diseases or transplant failure or death from any cause | From initial administration to Day 30 day after the last administration |
| Overall Survival (OS) | Time from randomization to death | From initial administration to day 30 days after the last administration |
| Incidence of Malignancy Relapse/Progression(MR),Non-Relapse Mortality(NRM) | From the date of first administration to the date of death due to recurrence/progression of non hematological diseases; the date of recurrence or progression of hematological diseases | From initial administration to 30 days after the last administration |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Incidence of AEs and SAEs | From initial administration to day 30 after the last administration |
| Tmax | The pharmacokinetic parameters were measured after single and multiple administration: peak time(Tmax) | 7 days after initial administration |
| Cmax | The pharmacokinetic parameters were measured after single and multiple administration: peak concentration(Cmax) | 7 days after initial administration |
| AUC0-t | The pharmacokinetic parameters were measured after single and multiple administration: area under the blood concentration-time curve (AUC0-t) | 7 days after initial administration |
| Suzhou |
| Jiangsu |
| 215008 |
| China |
| Hematology Hospital of the chinese Academy of Medical Sciences | Tianjing | Tianjing | 300020 | China |
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310012 | China |