SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
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.
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/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).
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 >20x10^9/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 ≥20×10^9/L or circulating blasts ≥10×10^9/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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1
Study ID
NCT06325748
Intervention or treatment
BIOLOGICAL: SENTI-202
Conditions
- AML/MDS
- CD33 Expressing Hematological Malignancies
- FLT3 Expressing Hematological Malignancies
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Research sites nearby
Closest Location:
Royal Prince Alfred Hospital
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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Who is running the clinical trial?
Senti Biosciences
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/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: SENTI-202 CAR NK cell therapy
| Biological: SENTI-202 |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability for dose determination of SENTI-202 | Incidence, 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 dose and dosing regimen | At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Anti-cancer activity of SENTI-202 | The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease | Through study completion, up to 2 years |
| Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202 | Levels of circulating SENTI-202 and peripheral cytokine levels will be measured to assess the PK/PDn profile of SENTI-202 | Through study completion, up to 2 years |
| Host immune response to SENTI-202 | Anti-SENTI-202 immune response and RCR will be measured in blood samples | Through study completion, up to 2 years |
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/MDSOther trials to consider
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