Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation
2026년 7월 9일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
7
단계
- 초기 1단계
연락처 및 위치
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연구 연락처
- 이름: Xiaoyu Zhu, MD, PhD
- 전화번호: +86-551-62282931
- 이메일: xiaoyuz@ustc.edu.cn
연구 연락처 백업
- 이름: Aijie Huang, MD
- 이메일: huangaijie@mail.ustc.edu.cn
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
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아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Platelet Engraftment
기간: From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.
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Platelet engraftment is defined as the first day of 7 consecutive days with platelet count ≥20×10^9/L without platelet transfusion.
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From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.
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Platelet Engraftment by Day 28
기간: At day 28 after umbilical cord blood transplantation
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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.
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At day 28 after umbilical cord blood transplantation
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Platelet Recovery by Day 28
기간: 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.
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At day 28 after umbilical cord blood transplantation
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Time to Platelet Count Thresholds
기간: 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.
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Median time to achieve platelet counts of ≥20×10^9/L, ≥50×10^9/L, and ≥100×10^9/L without platelet transfusion.
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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.
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Platelet Transfusion Volume
기간: From MegaLT Injection to 4 weeks after injection
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Total amount of platelet transfusion received by participants within 4 weeks after MegaLT Injection.
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From MegaLT Injection to 4 weeks after injection
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Neutrophil Engraftment by Day 28
기간: At day 28 after umbilical cord blood transplantation
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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.
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At day 28 after umbilical cord blood transplantation
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Megakaryocyte Level in Bone Marrow
기간: At 4 weeks after MegaLT Injection
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Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.
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At 4 weeks after MegaLT Injection
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adverse Events
기간: 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.
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From MegaLT Injection to 6 months after injection
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Bleeding Events
기간: From MegaLT Injection to 6 months after injection
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Incidence of bleeding events after MegaLT Injection, assessed using the WHO bleeding assessment scale.
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From MegaLT Injection to 6 months after injection
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Transplant-Related Complications and Mortality
기간: From umbilical cord blood transplantation to 100 days after transplantation
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Incidence of transplant-related complications and transplant-related mortality within 100 days after umbilical cord blood transplantation.
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From umbilical cord blood transplantation to 100 days after transplantation
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Graft-Versus-Host Disease
기간: From MegaLT Injection to 6 months after injection
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Incidence and severity of acute graft-versus-host disease and chronic graft-versus-host disease after MegaLT Injection.
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From MegaLT Injection to 6 months after injection
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Severe GVHD-Free, Relapse-Free Survival
기간: From MegaLT Injection to 6 months after injection
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Survival without severe graft-versus-host disease or relapse after MegaLT Injection.
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From MegaLT Injection to 6 months after injection
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Thromboembolic Events
기간: From MegaLT Injection to 6 months after injection
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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.
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From MegaLT Injection to 6 months after injection
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 31일
기본 완료 (추정된)
2026년 12월 31일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
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2026년 7월 4일
QC 기준을 충족하는 최초 제출
2026년 7월 9일
처음 게시됨 (실제)
2026년 7월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 9일
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2026년 7월 1일
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