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ACTIVE NOT RECRUITING
NCT06534255
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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