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Recruitment on holdLast updated: 18 May 2026

SENTI-202-101: This is a dose-finding study of SENTI-202, a type of immunotherapy called CAR NK Cell Therapy, in people with CD33 and/or FLT3 expressing blood cancers, including acute myeloid leukaemia and myelodysplastic syndromeA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 74

Trial acronym

SENTI-202-101

Clinical summary

Summary

The study will determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SENTI-202, an off-the-shelf logic gated CAR NK cell therapy, when given after lymphodepleting chemotherapy (Part 1) followed by disease-specific expansion cohorts at the RP2D (Part 2). 

Conditions

This trial is treating people with CD33 and/or FLT3 expressing blood cancers including relapsed or refractory acute myeloid leukaemia and myelodysplastic syndrome

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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On hold hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Senti Biosciences

Scientific Title

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

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