NCT05272813终止1 期
A Phase I/II Study to Investigate the Efficacy and Safety of MS-553 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2022年4月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Incidence of dose limiting toxicities
研究概览
简要总结
This is a Phase I/II, single arm, multi-center, open-label clinical trial of MS-553 in patients with CLL/SLL whose disease relapsed after or was refractory to at lease 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy) and who are indicated for treatment per IWCLL2018.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18 years or older, male or female.
- •Diagnosis of CLL/SLL per IWCLL2018 criteria.
- •Patients with relapsed or refractory CLL/SLL who have failed at least 1 prior therapy (chemotherapy and/or targeted drug therapy, which must include BTK inhibitor therapy), are indicated for treatment per IWCLL
- •Measurable lesions detected by contrast-enhanced computed tomography (CT): at least one lymph node with a maximum axis of more than 1.5 cm and one measurable vertical dimension.
- •WHO/ECOG performance status of 0 to
- •Patients with an estimated survival of more than 3 months.
排除标准
- •Biopsy-proven and pathologically confirmed current or past transformation to Richter's syndrome.
- •Patients with active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia and idiopathic thrombocytopenic purpura.
- •Patients who have received any of the following treatments within 14 days prior to the first dose:
- •Major surgery;
- •Glucocorticoids (at a dose equal to or greater than 20 mg/day prednisone or equivalent), unless used by inhalation, topical or intraarticular route, or unless necessary for premedication before and after iodinated contrast dye. After discussion with the Sponsor, steroid therapy at high doses for an extended period may be allowed under the following circumstances:
- •Treatment of autoimmune hemolysis or autoimmune thrombocytopenia associated with CLL/SLL;
- •Short-term (within 14 days) use to treat inactive infections of diseases unrelated to CLL/SLL (e.g. arthritis, asthma), which results in acute exacerbation, including steroid dose modifications required for adrenal insufficiency;
- •Cytotoxic chemotherapy or biologic therapy, excepting BCR pathway kinase inhibitors for which a washout of 24 hours prior to the first dose is required.
- •Toxicity from prior anti-tumor therapy (chemotherapy, radiotherapy, or biotherapy) did not restore to ≤ Grade 1 (except for alopecia); atrial fibrillation from prior treatment with BTK inhibitors did not restore to ≤ Grade
- •Central nervous system (CNS) leukemia or lymphoma, including a history of asymptomatic, previously treated CNS disease.
研究组 & 干预措施
MS-553 Low Dose
Experimental
MS-553 Low Dose PO BID
干预措施: MS-553 (Drug)
MS-553 Mid Dose-1
Experimental
MS-553 Mid Dose-1 PO BID
干预措施: MS-553 (Drug)
MS-553 Mid Dose-2
Experimental
MS-553 Mid Dose-2 PO BID
干预措施: MS-553 (Drug)
MS-553 High Dose
Experimental
MS-553 High Dose PO BID
干预措施: MS-553 (Drug)
结局指标
主要结局
Incidence of dose limiting toxicities
时间窗: 28 days
次要结局
- Overall response rate(up to 24 months)
- Time to tumor response(During intervention)
- Progression free survival(During intervention)
- Disease control rate(During intervention)
- Assessment of minimal residual disease(During intervention)
- Incidence and severity of adverse events(Assessed throughout the study from the time of first dose of study drug until 30 days after the patient's last dose of study drug or until the event has resolved, stabilized, or an outcome reached, whichever comes first regardless of timing of EoT visit)
- Overall survival(During intervention)
研究者
研究点 (1)
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