Study of the Efficacy and Safety of MegaLT Injection for Promoting Platelet Recovery After Umbilical Cord Blood Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7
- 主要终点
- Time to Platelet Engraftment
研究概览
简要总结
This is a single-arm, early safety and feasibility exploratory study to evaluate the efficacy and safety of MegaLT Injection in promoting platelet recovery after umbilical cord blood transplantation. Adults with malignant hematologic diseases who undergo umbilical cord blood transplantation will receive a single intravenous infusion of MegaLT Injection on day 14 after transplantation. Two dose levels will be evaluated sequentially, and platelet recovery, platelet transfusion requirements, and safety outcomes will be assessed.
详细描述
This study is designed as a single-arm, early safety and feasibility exploratory study of MegaLT Injection in patients undergoing umbilical cord blood transplantation. Eligible participants will receive MegaLT Injection by intravenous infusion on day 14 after transplantation. The study includes two sequential dose levels: 1×10^6/kg and 2.5×10^6/kg. Three participants are planned for each dose level, with a total planned enrollment of 7 participants after accounting for an approximately 10% dropout rate. The study will evaluate platelet engraftment, platelet recovery, platelet transfusion requirements, hematopoietic recovery, and safety outcomes including adverse events, bleeding events, thromboembolic events, graft-versus-host disease, and transplant-related mortality.
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
- •Age ≥18 years, male or female.
- •Patients with a definite diagnosis of hematologic malignancy who are undergoing umbilical cord blood transplantation.
- •Patients at day 14 after umbilical cord blood transplantation.
- •ECOG performance status ≤
- •Patients who voluntarily agree to participate in this clinical trial, fully understand the study content, and sign the informed consent form.
排除标准
- •Patients with relapse of any malignant tumor.
- •Pregnant or lactating women.
- •Patients with severe infection or severe cardiac, hepatic, pulmonary, renal, neurologic, or metabolic disease.
- •Patients with a history of severe thrombotic events or known risk factors for thrombosis. Exception: participants for whom the investigator determines that the potential benefit of study participation outweighs the potential risk of thromboembolic events.
- •Patients with uncontrolled infectious disease or other serious diseases, including but not limited to infection such as HIV positivity, congestive heart failure, unstable angina, cardiac arrhythmia, psychosis, social circumstances that would limit compliance with study requirements, or any condition that the treating physician considers may pose unpredictable risks.
- •Patients with active hepatitis B or hepatitis C.
- •Patients who have previously received organ transplantation or are planning to receive organ transplantation, except for hematopoietic stem cell transplantation.
- •Patients who participated in another clinical study and used any investigational drug or device within 30 days before the baseline visit. Participation in observational studies is allowed.
- •Patients considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.
结局指标
主要结局
Time to Platelet Engraftment
时间窗: From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.
Platelet engraftment is defined as the first day of 7 consecutive days with platelet count ≥20×10\^9/L without platelet transfusion.
Platelet Engraftment by Day 28
时间窗: At day 28 after umbilical cord blood transplantation
Cumulative incidence of platelet engraftment by day 28 after transplantation, defined as 7 consecutive days with platelet count ≥20×10\^9/L without platelet transfusion.
次要结局
- Platelet Recovery by Day 28(At day 28 after umbilical cord blood transplantation)
- Time to Platelet Count Thresholds(From umbilical cord blood transplantation until documented platelet count recovery at each threshold or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.)
- Platelet Transfusion Volume(From MegaLT Injection to 4 weeks after injection)
- Neutrophil Engraftment by Day 28(At day 28 after umbilical cord blood transplantation)
- Megakaryocyte Level in Bone Marrow(At 4 weeks after MegaLT Injection)