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.
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 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.
Single group
MegaLT Injection
Biological/VaccineMegaLT 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.
Time to Platelet Engraftment
Platelet engraftment is defined as the first day of 7 consecutive days with platelet count ≥20×10\^9/L without platelet transfusion.
Platelet Engraftment by Day 28
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.
Platelet Recovery by Day 28
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.
Time to Platelet Count Thresholds
Median time to achieve platelet counts of ≥20×10\^9/L, ≥50×10\^9/L, and ≥100×10\^9/L without platelet transfusion.
Platelet Transfusion Volume
Total amount of platelet transfusion received by participants within 4 weeks after MegaLT Injection.
Neutrophil Engraftment by Day 28
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.
Adverse Events
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.
Bleeding Events
Incidence of bleeding events after MegaLT Injection, assessed using the WHO bleeding assessment scale.
Transplant-Related Complications and Mortality
Incidence of transplant-related complications and transplant-related mortality within 100 days after umbilical cord blood transplantation.
Graft-Versus-Host Disease
Incidence and severity of acute graft-versus-host disease and chronic graft-versus-host disease after MegaLT Injection.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
