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A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.
Sponsor: Anhui Provincial Hospital
Summary
A study to evaluate the safety, efficacy, and pharmacokinetics of MegaLT in treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.
Key Details
Gender
All
Age Range
4 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2024-12-04
Completion Date
2026-05-22
Last Updated
2025-11-26
Healthy Volunteers
No
Conditions
Interventions
MegaLT injection
Three dose groups were set: 1×10\^6/kg, 5×10\^6/kg, and 1×10\^7/kg. The dose escalation was carried out in ascending order using a "3+3" design. To ensure participant safety, enrollment followed a "1+2" rule. Specifically, the first participant in each dose group received the cell infusion and was observed for 14 days. If no dose-limiting toxicity (DLT) was observed, the remaining two participants could then be enrolled and receive cell therapy at the same dose level.
Locations (1)
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui, China