NCT07753148尚未招募1 期
An Open-Label, Multi-Center Phase I Study to Investigate the Safety and Tolerability of REGN17235 in Patients With Clonal Cytopenia of Undetermined Significance and Low-Risk Myelodysplastic Syndrome With SF3B1 Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Occurrence of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study will test a study drug called REGN17235 (the "study drug") to see if it can help treat Clonal Cytopenia of Undetermined Significance (CCUS) and Low-Risk Myelodysplastic Syndrome (LR-MDS) with a specific genetic mutation (SF3B1 Mutation).
The study is looking at:
- What side effects the study drug might cause
- How well the study drug works
- How much of the study drug is in the blood at different times
- If the body makes antibodies (proteins that attach to substances your body does not recognize) against the study drug; this may cause the study drug to not work as well.
- What is the best dose of the study drug to treat CCUS and LR-MDS
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Presence of SF3B1 mutation in the bone marrow or peripheral blood AND diagnosis of low-risk MDS OR diagnosis of CCUS as defined by WHO 2022, 5th edition as described in the protocol
- •Adequate bone marrow function as described in the protocol; red blood cell transfusion dependence is permitted
- •Adequate hepatic and renal function as described in the protocol
排除标准
- •Clinically significant anemia due to non-MDS or non-CCUS etiologies (eg, iron deficiency, vitamin B12 or folate deficiency, autoimmune or hereditary hemolysis, or hemorrhage) diagnosed or treated within the last 3 months prior to informed consent
- •Recent or uncontrolled infections as described in the protocol
- •Diagnosed or treated for malignancy other than MDS as described in the protocol
- •Prior treatment with any systemic therapy for MDS or CCUS within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter
- •Allogeneic hematopoietic stem cell transplant within 100 days of enrollment or any signs or symptoms of ongoing Graft-Versus Host Disease (GVHD) as described in the protocol
- •Note: Other protocol defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
Part 1 Dose Escalation
Experimental
干预措施: REGN17235 (Drug)
Part 2 Safety Expansion
Experimental
干预措施: REGN17235 (Drug)
结局指标
主要结局
Occurrence of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 5 years
Severity of TEAEs
时间窗: Up to 5 years
Occurrence of Serious Adverse Events (SAEs)
时间窗: Up to 5 years
Severity of SAEs
时间窗: Up to 5 years
次要结局
- Concentration of REGN17235 in serum(Up to 5 years)
- Occurrence of Anti-Drug Antibodies (ADA) to REGN17235 in serum(Up to 5 years)
- Magnitude of ADA to REGN17235 in serum(Up to 5 years)
- Hematologic improvement per International Working Group (IWG) 2018(Up to 5 years)
研究者
相似试验
尚未招募
3 期
Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.NCT07608159Shanghai Pulmonary Hospital, Shanghai, China201
招募中
3 期
A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBCNCT07424287Suzhou Suncadia Biopharmaceuticals Co., Ltd.236
招募中
3 期
Sintilimab Versus Mitomycin in Combination With Capecitabine and IMRT for Limited-stage Anal Squamous Cell CarcinomaAnal Squamous Cell Carcinoma, Limited-stageNCT07692152Cancer Institute and Hospital, Chinese Academy of Medical Sciences350
招募中
2 期
9MW2821 Combined With Toripalimab in Perioperative Patients With Urothelial CancerNCT07314723Mabwell (Shanghai) Bioscience Co., Ltd.90
已完成
3 期
A Clinical Trial Evaluating the Safety of Hydronidone Capsules in Patients With Hepatic Fibrosis and Liver CirrhosisNCT07343778Beijing Continent Pharmaceutical Co, Ltd.337