Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06465446
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
A Study of IMM01 Plus Tiselizumab Versus Physicians Choice Chemotherapy in PDL1-refractory Classical Hodgkin Lymphoma
Sponsor:
ImmuneOnco Biopharmaceuticals Shanghai Inc
Organization:
ImmuneOnco Biopharmaceuticals Shanghai Inc
Study Overview
Official Title:
A Phase III Randomized Open-label Multicenter Clinical Study of IMM01 Timdarpacept in Combiniation With Tiselizumab Versus Physicians Choice Chemotherapy in PD-L1-refractory Classical Hodgkin Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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 this study is to compare efficacy of IMM01 plus Tiselizumab with physicians choice chemotherapy of bendamustine or gemcitabine in participants with PD-L1-refractory classical Hodgkin Lymphoma The study will also assess the safety and tolerability of IMM01 plus Tiselizumab The primary study hypotheses are that IMM01 plus Tiselizuma is superior to physicians choice chemotherapy with respect to progression-free survival PFS and overall survival OS
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