Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548230
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-06
Brief Title:
A Phase 1B2A Trial of NADUNOLIMAB in Combination With Azacitidine WithWithout Venetoclax in Patients With Myelodysplastic Syndrome MDS and Acute Myelogenous Leukemia AML
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1B2A Trial of NADUNOLIMAB in Combination With Azacitidine WithWithout Venetoclax in Patients With Myelodysplastic Syndrome MDS and Acute Myelogenous Leukemia AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
To evaluate safety and determine the recommended Phase II dose RP2D We hypothesize that targeting leukemia stemprogenitor cells LSCs with nadunolimab IL1RAP antibody alone or in combination with current therapies of azacitidine HMA and venetoclax Bcl-2 inhibitor is an effective treatment strategy for high-risk MDS and AML and with a clinical trial we will establish the safety and the early efficacy of this approach
Detailed Description:
Primary Objectives
To determine the safety and recommended phase 2 dose RP2D of nadunolimab in combination with azacitidine in intermediatehighvery high risk MDS International prognostic scoring system revisedIPSS-R who are untreated or had up to 2 prior treatments Arm 1 or in combination with azacitidine and venetoclax in patients with relapsedrefractory AML receiving treatment as first or second salvage Arm 2
Secondary Objectives
To assess the complete remission CR CR with incomplete count recovery CRi partial remission PR morphologic leukemia free state MLFS rate as per European Leukemia Network 2017 AML response criteria within 6 cycles of treatment initiation in patients with relapsed refractory AML
To assess Overall Response Rate ORR defined as CR marrow complete remission mCR partial remission PR CR with partial hematologic recovery CRh hematological improvement HI as per International Working Group 2023 criteria for MDS in patients with intermediate high very high risk MDS IPSS-R within 6 cycles of treatment initiation
To determine the duration of response DOR
Exploratory Objectives
To assess effects on exploratory biomarkers including serum biomarkers alterations in hematopoietic subpopulations as measured by multicolor flow cytometry and multimodal single cell analysis and effects on the leukemic cells as assessed by gene panel analysis andor single cell DNA-analysis To evaluate exposure by measuring PK To evaluate immunogenicity by assessing antidrug antibodies ADA
To determine the safety and recommended phase 2 dose RP2D of nadunolimab in combination with azacitidine in intermediatehighvery high risk MDS International prognostic scoring system revisedIPSS-R who are untreated or had up to 2 prior treatments Arm 1 or in combination with azacitidine and venetoclax in patients with relapsedrefractory AML receiving treatment as first or second salvage Arm 2
Secondary Objectives
To assess the complete remission CR CR with incomplete count recovery CRi partial remission PR morphologic leukemia free state MLFS rate as per European Leukemia Network 2017 AML response criteria within 6 cycles of treatment initiation in patients with relapsed refractory AML
To assess Overall Response Rate ORR defined as CR marrow complete remission mCR partial remission PR CR with partial hematologic recovery CRh hematological improvement HI as per International Working Group 2023 criteria for MDS in patients with intermediate high very high risk MDS IPSS-R within 6 cycles of treatment initiation
To determine the duration of response DOR
Exploratory Objectives
To assess effects on exploratory biomarkers including serum biomarkers alterations in hematopoietic subpopulations as measured by multicolor flow cytometry and multimodal single cell analysis and effects on the leukemic cells as assessed by gene panel analysis andor single cell DNA-analysis To evaluate exposure by measuring PK To evaluate immunogenicity by assessing antidrug antibodies ADA
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