Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation
9 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
7
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xiaoyu Zhu, MD, PhD
- Número de teléfono: +86-551-62282931
- Correo electrónico: xiaoyuz@ustc.edu.cn
Copia de seguridad de contactos de estudio
- Nombre: Aijie Huang, MD
- Correo electrónico: huangaijie@mail.ustc.edu.cn
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to Platelet Engraftment
Periodo de tiempo: 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.
|
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Platelet Engraftment by Day 28
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Platelet Recovery by Day 28
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: At 4 weeks after MegaLT Injection
|
Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.
|
At 4 weeks after MegaLT Injection
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adverse Events
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Transplant-Related Complications and Mortality
Periodo de tiempo: 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
|
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Graft-Versus-Host Disease
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Thromboembolic Events
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2026
Finalización del estudio (Estimado)
30 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
4 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
9 de julio de 2026
Publicado por primera vez (Actual)
10 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MegaLT-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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