Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06325748
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-13
Brief Title:
SENTI-202 Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 andor FLT3 Blood Cancers Including AMLMDS
Sponsor:
Senti Biosciences
Organization:
Senti Biosciences
Study Overview
Official Title:
SENTI-202-101 A Phase 1 Multicenter Open-Label Study of SENTI-202 a Selective Off-the-Shelf Logic Gated CAR NK Cell Therapy in Subjects With CD33 andor FLT3 Expressing Hematological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This is an open-label study of the safety biodynamics and anti-cancer activity of SENTI-202 an off-the-shelf logic gated CAR NK cell therapy in patients with CD33 andor FLT3 expressing blood cancers including AML and MDS
Detailed Description:
This is a dose-finding study of SENTI-202 comprised of an initial dose finding using a modified 33 study design to determine the maximum tolerated dose MTD and recommended phase two dose RP2D of SENTI-202 when administered after lymphodepleting chemotherapy Part 1 followed by disease-specific expansion cohorts at the RP2D Part 2
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