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ACTIVE NOT RECRUITING
NCT06325748
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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