Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:27 PM
Study NCT ID:
NCT06347458
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children
Sponsor:
Guangzhou Bio-gene Technology Co., Ltd
Organization:
Study Overview
Official Title:
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 in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-arm, single-dose dose-escalation and dose-expansion study.
Detailed Description:
Child 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: