SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Ca… (NCT06325748) | Clinical Trial Compass
Active — Not RecruitingPhase 1
SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
United States21 participantsStarted 2024-04-22
Plain-language 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.
Who can participate
Age range18 Years – 74 Years
SexALL
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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 ≥20Ă—109/L or circulating blasts ≥10Ă—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-respon…
What they're measuring
1
Safety and tolerability for dose determination of SENTI-202
Timeframe: At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years
2
For subjects enrolled in the Dose Expansion Cohort(s): Anti-cancer activity of SENTI-202
Timeframe: Through study completion, up to 2 years