Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:26 PM
Study NCT ID:
NCT04240704
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-01-23
Brief Title:
Safety and Preliminary Efficacy of JBH492 Monotherapy in Patients With CLL and NHL
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IIb Open-label Multi-center Dose Escalation Study of JBH492 in Patients With RelapsedRefractory Chronic Lymphocytic Leukemia CLL and Non-Hodgkins Lymphoma NHL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
The purpose of the First-In-Human study is to assess safety tolerability pharmacokinetics PK immunogenicity and preliminary efficacy of JBH492 as single agent
Detailed Description:
This is a FIH open-label phase IIb multi-center study which consists of a dose escalation part of JBH492 as a single agent followed by an expansion part The escalation part will be conducted in patients with relapsedrefractory chronic lymphocytic leukemia rr CLL and Non-Hodgkins Lymphoma rr NHL Once the MTDRD of single agent JBH492 is determined the study will continue with an expansion part with single agent JBH492 in defined patient populations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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