NCT04944043进行中（未招募）1 期
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).
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 12
- 主要终点
- Recommended phase II dose (RP2D)
研究概览
简要总结
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.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TQ05105 Tablet
Experimental
TQ05105 tablet 10mg given orally, twice daily in 28-cycle.
干预措施: TQ05105 Tablet (Drug)
结局指标
主要结局
Recommended phase II dose (RP2D)
时间窗: Baseline up to 4 weeks
Recommended dose for phase II (Patients in phase Ib)
Best Overall Response Rate (BOR)
时间窗: Baseline up to 96 weeks
Percentage of participants achieving complete response (CR) and partial response (PR). (Patients in phase II)
Maximal Tolerable Dose (MTD)
时间窗: 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)
次要结局
- Changes in symptom burden(Baseline up to 96 weeks)
- Time to reach maximum plasma concentration (Tmax)(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.)
- Overall Response Rate (ORR)(Baseline up to 52 weeks)
- Non-relapse mortality (NRM)(Baseline up to 96 weeks)
- Duration of Response (DOR)(Baseline up to 96 weeks)
- Overall survival (OS)(Baseline up to death event, up to 5 years.)
- Failure Free Survival (FFS)(Baseline up to 12 months)
- Maximum plasma concentration (Cmax)(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.)
- Changes in glucocorticoid dose(Baseline up to 96 weeks)
- Incidence rate of adverse event(Baseline up to 96 weeks.)
- Area under the plasma concentration time curve (AUC0-t)(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.)
研究者
研究点 (12)
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