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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnhui Provincial Hospital

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

Treatment groups

7 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators