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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
Trial Status: active
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.
Inclusion Criteria
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
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT06325748.
