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SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
Sponsor: Senti Biosciences
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 and/or FLT3 expressing blood cancers, including AML and MDS.
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 and/or FLT3 Expressing Malignancies
Key Details
Gender
All
Age Range
18 Years - 74 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2024-04-22
Completion Date
2040-08
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
SENTI-202
SENTI-202 is an investigational off-the-shelf CAR NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematological malignancies while sparing healthy cells using a NOT logic gate. SENTI-202 is administered in either a 3 dose regimen (Schedule 1: Days 0, 7, 14) or a 5 dose regimen (Schedule 2: Days 0, 3, 7, 10, 14) of a 28-day treatment cycle following a lymphodepletion conditioning regimen of fludarabine and cytarabine (flu/Ara-C). Subjects will receive a minimum of 1 and maximum of 3 treatment cycles to achieve optimal response with the optionality of an additional consolidation cycle thereafter. Additional dosing schedules may be explored depending on study data.
Locations (8)
UCLA Medical Center
Los Angeles, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Methodist Healthcare
San Antonio, Texas, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Peter MacCallum Cancer Center
Melbourne, Victoria, Australia