About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MegaLT Injection