Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05924750
Status:
RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-06-16
Brief Title:
A Study of BL-M11D1 in Patients With RelapsedRefractory Acute Myeloid Leukemia
Sponsor:
Sichuan Baili Pharmaceutical Co Ltd
Organization:
Sichuan Baili Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Clinical Trial to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Efficacy of BL-M11D1 in RelapsedRefractory Acute Myeloid Leukemia AML Patients
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Ia To observe the safety and tolerability of BL-M11D1 in patients with relapsedrefractory acute myeloid leukemia to determine the maximum tolerated dose MTD and dose-limiting toxicity DLT of BL-M11D1 Ib Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study RP2D
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None