Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508489
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
A Study to Investigate Natural Killer Cell Engager SAR443579 With Different Agents in Participants With Hematological Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1Phase 2 Randomized Open-label Multi Cohort Multi Center Study Assessing the Safety Tolerability and Preliminary Efficacy of SAR443579 a Natural Killer Cell Engager NKCE Targeting CD123 Administered With Different Agents in Participants With CD123 Expressing Hematological Malignancies
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:
This is a parallel Phase 1Phase 2 randomized open label multi-cohort multi-center study assessing the safety tolerability and preliminary efficacy of SAR443579 with different agents for treatment in adolescent andor adult participants with CD123 expressing hematological malignancies
This protocol is structured as a master protocol containing common protocol elements Individual sub-studies will explore SAR443579 with combination partners which may include approved or investigational agents
Experimental sub-studies will be tested through 3 parts
Part 1 dose finding such as dose escalation safety run-in Part 2 dose optimization when applicable Part 3 dose expansion In each sub-study a dose escalation will identify preliminary recommended dose for expansion pRDE of SAR443579 and its respective combination partner Following the determination of the preliminary RDE additional participants will be enrolled in the dose expansion part or if dose optimization needs to be further evaluated additional participants will be enrolled in the dose optimizationexpansion part Dose optimization and dose expansion part could involve randomization depending on specific sub-study design
Study will consist of a screening period treatment period and follow-up period
Participants will receive study treatment until documented disease progression unacceptable adverse events participants decision to stop study treatment or completion of the maximum cycles allowed in the sub-studies or the participant meets other criteria for discontinuation per study protocol whichever occurs first
This protocol is structured as a master protocol containing common protocol elements Individual sub-studies will explore SAR443579 with combination partners which may include approved or investigational agents
Experimental sub-studies will be tested through 3 parts
Part 1 dose finding such as dose escalation safety run-in Part 2 dose optimization when applicable Part 3 dose expansion In each sub-study a dose escalation will identify preliminary recommended dose for expansion pRDE of SAR443579 and its respective combination partner Following the determination of the preliminary RDE additional participants will be enrolled in the dose expansion part or if dose optimization needs to be further evaluated additional participants will be enrolled in the dose optimizationexpansion part Dose optimization and dose expansion part could involve randomization depending on specific sub-study design
Study will consist of a screening period treatment period and follow-up period
Participants will receive study treatment until documented disease progression unacceptable adverse events participants decision to stop study treatment or completion of the maximum cycles allowed in the sub-studies or the participant meets other criteria for discontinuation per study protocol whichever occurs first
Detailed Description:
Substudy 01
Title A Phase 1Phase 2 open-label multi-center study assessing the safety tolerability and the preliminary efficacy of SAR443579 administered in combination with azacitidine venetoclax in adult participants with CD123 expressing newly diagnosed Acute Myeloid Leukemia ND-AML that are ineligible for intensive chemotherapy
Short title A study to investigate natural killer cell engager SAR443579 in combination with azacitidine venetoclax in adult participants with newly diagnosed acute myeloid leukemia
The expected duration of the study for a participant is approximately about 25 years The study duration includes a screening period an induction and maintenance After the end of study treatment participants will enter the follow-up period for up to 2 years
Planned number of participants
22 participants planned to be screened 8 being adults and 14 being elderly 9-18 participants planned to be enrolled dose escalation part
Enrollment will be paused upon completion of Part 1 Dose Escalation The available data will be reviewed and the recommended doses and schedule for optimization will be selected by the study board Enrollment in the Part 2 Dose optimization and Part 3 Dose expansion will be provided in a future protocol amendment
Title A Phase 1Phase 2 open-label multi-center study assessing the safety tolerability and the preliminary efficacy of SAR443579 administered in combination with azacitidine venetoclax in adult participants with CD123 expressing newly diagnosed Acute Myeloid Leukemia ND-AML that are ineligible for intensive chemotherapy
Short title A study to investigate natural killer cell engager SAR443579 in combination with azacitidine venetoclax in adult participants with newly diagnosed acute myeloid leukemia
The expected duration of the study for a participant is approximately about 25 years The study duration includes a screening period an induction and maintenance After the end of study treatment participants will enter the follow-up period for up to 2 years
Planned number of participants
22 participants planned to be screened 8 being adults and 14 being elderly 9-18 participants planned to be enrolled dose escalation part
Enrollment will be paused upon completion of Part 1 Dose Escalation The available data will be reviewed and the recommended doses and schedule for optimization will be selected by the study board Enrollment in the Part 2 Dose optimization and Part 3 Dose expansion will be provided in a future protocol amendment
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