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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 Hematological Malignancies
Description
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.This is a dose-finding study of SENTI-202, comprised of an initial dose finding using a modified "3+3" 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).
Trial Eligibility
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
Study Info
Organization
Senti Biosciences
Primary Outcome
Safety and tolerability for dose determination of SENTI-202
Interventions
Locations Recruiting
UCLA Medical Center
United States, California, Los Angeles
Colorado Blood Cancer Institute
United States, Colorado, Denver
Mayo Clinic
United States, Florida, Jacksonville
TriStar Bone Marrow Transplant
United States, Tennessee, Nashville
MD Anderson Cancer Center
United States, Texas, Houston
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