Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580301
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Study of YK012 in B-cell Acute Lymphoblastic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Multi-Center Phase IbII Study to Evaluate the Safety Tolerability Pharmacokinetics and Preliminary Anti-tumor Activity of YK012 in Participants with B-cell Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety tolerability pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia B-ALL
Detailed Description:
YK012 is a bispecific antibody designed to link B cells and T cells resulting in T-cell activation and a cytotoxic T-cell response against cluster of differentiation CD19 expressing cells Relapsedrefractory B-ALL in adult patients is an aggressive malignant disease with dismal prognosis This study is designed in 2 parts as described below Phase Ib dose escalation and Phase II dose expansion If in Phase Ib it is observed in adult subjects at doses with manageable risk and antitumor activity studies in pediatric subjects can be initiated to explore safety and efficacy in pediatric subjects as well as pharmacokinetic profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None