NCT04941404终止1 期
A Single Arm, Open-label, Multicenter, Phase Ib Study of TQ05105 Tablets in Subjects With aGVHD
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 8
- 主要终点
- Drug tolerance of the first cycle (Stage 1)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participated in the study and signed an informed consent, with good compliance.
- •Aged 12-75, gender is not limited.
- •Subjects who has received allogeneic hematopoietic stem cell transplantation (allo-HSCT) previously.
- •Clinically suspected grades II to IV acute GVHD as per MAGIC guidelines.
- •Drug resistance after glucocorticoid treatment.
- •Absolute neutrophils count (ANC) >1×109/L,Platelet(PLT)≥20×109/L within 48 hours before initial treatment.
- •Male or female subjects should agree use an adequate method of contraception during the study and within 6 months after the end of the study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the first administration.
排除标准
- •Subjects with a history of progressive multifocal leukoencephalopathy.
- •Subjects with many factors influencing oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.).
- •Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, etc..
- •Severe respiratory diseases (requiring mechanical ventilation or O2 saturation < 90%), active tuberculosis, pulmonary hypertension and pulmonary embolism, etc..
- •Subjects with a history of psychotropic drug abuse and can not quit or have mental disorders.
- •Subjects with any severe and/or uncontrolled disease, including:
- •(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.
- •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.
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: TQ05105 tablets (Drug)
结局指标
主要结局
Drug tolerance of the first cycle (Stage 1)
时间窗: Day 28 after initial administration
Dose-limiting toxicity events related to the investigational drug occured within 28 days after initial administration
Objective Response Rate (ORR) at Day 28 (Stage 2)
时间窗: Day 28 after initial administration
Percentage of subjects with complete response (CR) or very good partial response (VGPR) or partial response (PR) at Day 28
次要结局
- ORR at Day 28 and Day 56(Day 28 and Day 56 after initial administration)
- Cumulative dose of glucocorticoid at Day 56(Day 56 after initial administration)
- Overall Survival (OS)(From initial administration to day 30 days after the last administration)
- Duration of Response (DOR)(From initial administration to day 30 after the last administration)
- CR Rate at Day 28(Day 28 after initial administration)
- Event Free Survival (EFS）(From initial administration to Day 30 day after the last administration)
- Tmax(7 days after initial administration)
- AUC0-t(7 days after initial administration)
- Incidence of Malignancy Relapse/Progression(MR),Non-Relapse Mortality(NRM)(From initial administration to 30 days after the last administration)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(From initial administration to day 30 after the last administration)
- Cmax(7 days after initial administration)
研究者
研究点 (8)
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