Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT06812104
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Trial of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Kyowa Kirin Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I, Multicenter, Uncontrolled, Open-label, Non-randomized, Dose-escalation Study of KK2845 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2025-11
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 the first in human study of KK2845. This trial consists of Part 1 (Dose escalation) and Part 2 (Backfill). In Part 1, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2845 in patients with relapsed or refractory acute myeloid leukemia. Part 2 will collect additional data at tolerated doses of KK2845.
Detailed Description:
None
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?: