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

9. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

7

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Platelet Engraftment
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Platelet Recovery by Day 28
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: At 4 weeks after MegaLT Injection
Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.
At 4 weeks after MegaLT Injection

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Events
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Anhui Provincial Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

4. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MegaLT-2026

Plan for individuelle deltagerdata (IPD)

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