Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06232096
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-01-22
Brief Title:
A Study of MBS314 in Participants With RelapsedRefractory Multiple Myeloma
Sponsor:
Beijing Mabworks Biotech Co Ltd
Organization:
Beijing Mabworks Biotech Co Ltd
Study Overview
Official Title:
A Phase ⅠⅡ Study to Evaluate the Safety Tolerability Pharmacokinetics Pharmacodynamics and Efficacy of MBS314 Injection in Patients With RelapsedRefractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2023-12
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 Phase IⅡ multicenter open-label dose-escalation study designed to evaluate the safety tolerability pharmacokinetics PK pharmacodynamicsPD and efficacy of a novel asymmetric trivalent tri-specific humanized antibody MBS314 administered by intravenous IV infusion in participants with relapsed or refractory multiple myeloma This entry-to-human study is divided in 2 parts a dose escalation part Phase Ⅰa and an expansion part Phase ⅠbⅡ
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