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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

PHASE1RECRUITING

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.

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-04-22

    Primary completion: 2025-09-01

    Study completion finish: 2040-08-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06325748

    Intervention or treatment

    BIOLOGICAL: SENTI-202

    Conditions

    • AML/MDS
    • CD33 Expressing Hematological Malignancies
    • FLT3 Expressing Hematological Malignancies
    Image related to AML/MDS
    • Condition: AML/MDS, CD33 Expressing Hematological Malignancies and more

    • BIOLOGICAL: SENTI-202

    • Camperdown, New South Wales, Australia and more

    • Sponsor: Senti Biosciences

    Find a site

    Closest Location:

    Royal Prince Alfred Hospital

    Research sites nearby

    Select from list below to view details:

    • Royal Prince Alfred Hospital

      Camperdown, New South Wales, Australia

    • Peter MacCallum Cancer Center

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: SENTI-202 CAR NK cell therapy
    • Part 1 Dose Finding: Sequential cohorts will receive doses of SENTI-202 using a modified 3+3 study design to determine the recommended phase 2 dose (RP2D). The starting dose will be 1 billion cells. Other doses may be explored depending on study data.
    • Part 2 Cohort Expansion: After determination of the RP2D, additional subjects will be enrolled in disease-specific expansion cohorts at that dose to further explore safety, biodynamics, and anti-cancer activity of SENTI-202
    BIOLOGICAL: SENTI-202
    • SENTI-202 is an investigational off-the-shelf CAR NK cell therapy designed to selectively target and eliminate CD33 and/or FLT3 expressing hematological malignancies while sparing healthy cells using a NOT logic gate.
    • SENTI-202 is administered in 3 weekly doses (Days 0, 7, 14) of a 28-day treatment cycle following a lymphodepletion conditioning regimen of fludarabine and cytarabine (flu/Ara-C). Subjects will receive a minimum of 1 and maximum of 3 treatment cycles.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety and tolerability for dose determination of SENTI-202Incidence, type, frequency, and severity of adverse events and dose limiting toxicities will be assessed to determine the maximum tolerated dose and/or recommended phase 2 doseAt the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Anti-cancer activity of SENTI-202The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective diseaseThrough study completion, up to 2 years
    Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202Levels of circulating SENTI-202 and peripheral cytokine levels will be measured to assess the PK/PDn profile of SENTI-202Through study completion, up to 2 years
    Host immune response to SENTI-202Anti-SENTI-202 immune response and RCR will be measured in blood samplesThrough study completion, up to 2 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS

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