SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS

Running, not enrolling · Phase 1

Conditions studied: AML/MDS, CD33 Expressing Hematological Malignancies, FLT3 Expressing Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT06325748

Run by

Senti Biosciences

People needed

21

Starts

2024-04-22

Expected to finish

2040-08-01

Last updated by the study team

2026-02-12

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with CD33 and/or FLT3 expressing malignancies, including:
• Relapsed refractory acute myeloid leukemia (AML) with morphologic relapse as defined by ≥5% bone marrow blasts who have received at least 1 prior line, but no more than 3 prior lines of standard anti-AML therapy. Subjects with FLT3-mutated or IDH ½-mutated disease must have received at least one prior targeted therapy.
• Relapsed refractory myelodysplastic syndrome (MDS) with increased blasts who have received at least 1 prior line, but no more than 2 prior lines of anti-MDS therapy
• Other hematological malignancies who have received at least 1 prior line of standard of care for the respective disease
• Documentation of CD33 expression (or FLT3 expression if available) by individual institutional standard of care
• ECOG performance score of 0-1
• Adequate organ function including platelet count >20x109/L (platelet transfusion is permitted)
• Adequate recovery from toxicities from previous cancer treatments, as described in the study protocol
• Willing and able to provide written informed consent

You may not qualify if…

• White blood cell (WBC) count of ≥20×109/L or circulating blasts ≥10×109/L or rapidly progressive/hyperproliferative disease
• Acute promyelocytic leukemia with t(15;17) (q22;q12) or abnormal promyelocytic leukemia/retinoic acid receptor alpha (APML-RARA)
• MDS with fibrosis (MDS-f) or known prior history of constitutional conditions/syndromes with chemo-responsive AML
• Evidence of leukemic meningitis or known active central nervous system disease
• Presence of extra-medullary disease or myeloid sarcoma alone with no morphologic hematologic relapse
• Prior use of certain anti-cancer therapies and/or use within a certain number of days prior to SENTI-202 study treatment, as described in the study protocol
• Hematopoietic cell transplantation (HCT) less than 100 days prior to the first dose of SENTI-202
• Prior NK cell or CAR T cell therapy at any time
• Prior donor lymphocyte infusion (DLI), except if after HCT for MRD+ disease
• Medical conditions or medications prohibited by the study protocol
• Pregnant or breastfeeding female

Where it is running

• 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

Full record on ClinicalTrials.gov

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