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Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation

9 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

7

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: MegaLT Injection
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Time to Platelet Engraftment
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Platelet Recovery by Day 28
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: At 4 weeks after MegaLT Injection
Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.
At 4 weeks after MegaLT Injection

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse Events
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Severe GVHD-Free, Relapse-Free Survival
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Anhui Provincial Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 juli 2026

Primaire voltooiing (Geschat)

31 december 2026

Studie voltooiing (Geschat)

30 juni 2027

Studieregistratiedata

Eerst ingediend

4 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

9 juli 2026

Eerst geplaatst (Werkelijk)

10 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

9 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MegaLT-2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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