Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation
2026年7月9日 更新者：Anhui Provincial Hospital
Study of the Efficacy and Safety of MegaLT Injection for Promoting Platelet Recovery After Umbilical Cord Blood Transplantation
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
7
阶段
- 第一阶段早期
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Xiaoyu Zhu, MD, PhD
- 电话号码：+86-551-62282931
- 邮箱：xiaoyuz@ustc.edu.cn
研究联系人备份
- 姓名：Aijie Huang, MD
- 邮箱：huangaijie@mail.ustc.edu.cn
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 ≤2.
- Patients who voluntarily agree to participate in this clinical trial, fully understand the study content, and sign the informed consent form.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：MegaLT Injection
Participants will receive MegaLT Injection by intravenous infusion on day 14 after umbilical cord blood transplantation.
Dose escalation will proceed sequentially from 1×10^6/kg to 2.5×10^6/kg.
Each participant will receive one assigned cell dose; multiple infusions may be considered if necessary according to the protocol.
|
MegaLT Injection is prepared from eligible umbilical cord blood cells through directed expansion and quality control to obtain a megakaryocyte cell product.
Participants will receive MegaLT Injection by intravenous infusion on day 14 after umbilical cord blood transplantation.
The assigned dose will be 1×10^6/kg or 2.5×10^6/kg, with sequential dose escalation from the low-dose level to the high-dose level.
Each participant will receive one assigned cell dose; multiple infusions may be considered if necessary according to the protocol.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to Platelet Engraftment
大体时间：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.
|
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 by Day 28
大体时间：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.
|
At day 28 after umbilical cord blood transplantation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Platelet Recovery by Day 28
大体时间：At day 28 after umbilical cord blood transplantation
|
Cumulative rate of platelet recovery by day 28 after transplantation, defined as platelet count ≥50×10^9/L for 7 consecutive days without platelet transfusion.
|
At day 28 after umbilical cord blood transplantation
|
|
Time to Platelet Count Thresholds
大体时间：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.
|
Median time to achieve platelet counts of ≥20×10^9/L, ≥50×10^9/L, and ≥100×10^9/L without platelet transfusion.
|
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
大体时间：From MegaLT Injection to 4 weeks after injection
|
Total amount of platelet transfusion received by participants within 4 weeks after MegaLT Injection.
|
From MegaLT Injection to 4 weeks after injection
|
|
Neutrophil Engraftment by Day 28
大体时间：At day 28 after umbilical cord blood transplantation
|
Cumulative incidence of neutrophil engraftment by day 28 after transplantation, defined as an absolute neutrophil count ≥0.5×10^9/L for 3 consecutive days.
|
At day 28 after umbilical cord blood transplantation
|
|
Megakaryocyte Level in Bone Marrow
大体时间：At 4 weeks after MegaLT Injection
|
Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.
|
At 4 weeks after MegaLT Injection
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Adverse Events
大体时间：From MegaLT Injection to 6 months after injection
|
Incidence of adverse events after MegaLT Injection, including clinical symptoms and laboratory abnormalities.
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.
|
From MegaLT Injection to 6 months after injection
|
|
Bleeding Events
大体时间：From MegaLT Injection to 6 months after injection
|
Incidence of bleeding events after MegaLT Injection, assessed using the WHO bleeding assessment scale.
|
From MegaLT Injection to 6 months after injection
|
|
Transplant-Related Complications and Mortality
大体时间：From umbilical cord blood transplantation to 100 days after transplantation
|
Incidence of transplant-related complications and transplant-related mortality within 100 days after umbilical cord blood transplantation.
|
From umbilical cord blood transplantation to 100 days after transplantation
|
|
Graft-Versus-Host Disease
大体时间：From MegaLT Injection to 6 months after injection
|
Incidence and severity of acute graft-versus-host disease and chronic graft-versus-host disease after MegaLT Injection.
|
From MegaLT Injection to 6 months after injection
|
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Severe GVHD-Free, Relapse-Free Survival
大体时间：From MegaLT Injection to 6 months after injection
|
Survival without severe graft-versus-host disease or relapse after MegaLT Injection.
|
From MegaLT Injection to 6 months after injection
|
|
Thromboembolic Events
大体时间：From MegaLT Injection to 6 months after injection
|
Incidence and severity of thromboembolic events after MegaLT Injection, including deep vein thrombosis and pulmonary embolism.
Relevant indicators such as D-dimer will be dynamically monitored.
|
From MegaLT Injection to 6 months after injection
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月31日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年6月30日
研究注册日期
首次提交
2026年7月4日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月10日
研究记录更新
最后更新发布 (实际的)
2026年7月10日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.