NCT06534255

A Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of MegaLT Injection for Treating Refractory Thrombocytopenia Following Radiotherapy, Chemotherapy, or Transplantation.

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 4 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the safety, efficacy, and pharmacokinetics of MegaLT in treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Detailed description

A single-center, open-label, dose-escalation study to assess the safety, efficacy, and pharmacokinetics of MegaLT for treating refractory thrombocytopenia following radiotherapy, chemotherapy, or transplantation.

Conditions

• Refractory Thrombocytopenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-06-19
• Completion: 2026-05-22
• First posted: 2024-08-02
• Last updated: 2026-04-14

Locations

1 site across 1 country: China