NCT07052006进行中（未招募）2 期
A Phase 2a Study of HT-6184 in Subjects With IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 19
- 主要终点
- The rate of hematological improvement.
研究概览
简要总结
This research is being conducted to asses if HT-6184 is effective in the treatment of Very Low, Low, or Intermediate Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia.
The study includes a 28-day Screening Period followed by a 16- or 32-week Treatment Period.
Participants will be monitored at each cycle for drug tolerance, safety, and hematological response. A response assessment will occur after 16 weeks of study treatment.
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
- •≥ 18 years of age.
- •Signed Informed Consent Form (ICF).
- •Adequate organ function.
- •A documented diagnosis of MDS or non-proliferative Myelodysplastic/myeloproliferative neoplasm (MDS/MPN).
- •Less than 10% bone marrow myeloblasts.
- •Refractory or intolerant of, or ineligible for treatment with an erythroid stimulating agent (ESA).
- •Prior ESA treatment must have been discontinued ≥ 2 weeks prior to date of study treatment.
- •Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or
- •Subjects must have symptomatic anemia.
- •Subjects with NGS (Next-generation sequencing) myeloid-specific somatic gene mutation profile with ≥ 5 % quantitation of clone size by variant allele frequency (VAF).
- •Women of child-bearing potential using an acceptable double-barrier method of contraception.
- •Male subjects who are using an acceptable method of contraception.
排除标准
- •Other causes of anemia such as iron deficiency.
- •Clinically significant anemia resulting from B12 or folate deficiencies, autoimmune or hereditary hemolysis, or gastrointestinal bleeding.
- •Women must not be pregnant or breastfeeding.
- •Presence of concomitant intercurrent illness which, in the opinion of the Investigator, would compromise safe participation in the study.
- •Secondary MDS.
- •Treatment with cytotoxic chemotherapeutic agents or experimental agents for the treatment of MDS within 4 weeks of study treatment.
- •Chronic use of systemic corticosteroids for comorbid or study disease condition within last 4 weeks of study treatment.
- •Prior history of malignancy other than MDS.
- •Subject has undergone a stem cell, bone marrow or solid organ transplant
- •Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •Prior treatment with disease modifying agents.
- •Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •Loss of ≥ 350 ml of blood within 90 days before the first dose of Investigational Product.
研究组 & 干预措施
HT-6184
Experimental
干预措施: HT-6184 (Drug)
结局指标
主要结局
The rate of hematological improvement.
时间窗: 16 weeks
次要结局
未报告次要终点
研究者
研究点 (19)
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