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Keep this study
Lead
Senti Biosciences
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/or 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).
Age
18–74
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
