NCT06118788

Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

A Single-arm, Dose-escalation and Dose-expansion Phase I Clinical Study to Evaluate the Tolerability, Safety and Preliminary Efficacy of BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Guangzhou Bio-gene Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, single-dose dose-escalation and dose-expansion study.

Detailed description

Patients with relapsed/refractory acute myeloid leukemia (r/r AML) were enrolled in the trial, which was divided into two parts: dose-escalation phase and dose-expansion phase.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
BIOLOGICAL	BG1805	A single infusion of BG1805 Injection administered intravenously.

Timeline

• Start date: 2024-03-07
• Primary completion: 2027-03-01
• Completion: 2027-07-01
• First posted: 2023-11-07
• Last updated: 2025-04-17

Locations

3 sites across 1 country: China