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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06325748
Registration number
NCT06325748
Ethics application status
Date submitted
13/03/2024
Date registered
22/03/2024
Date last updated
5/06/2024
Titles & IDs
Public title
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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Scientific title
SENTI-202-101: 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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Secondary ID [1]
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SENTI-202-101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
AML/MDS
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CD33 Expressing Hematological Malignancies
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FLT3 Expressing Hematological Malignancies
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - SENTI-202
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
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and tolerability for dose determination of SENTI-202
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Assessment method [1]
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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
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Timepoint [1]
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At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years
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Secondary outcome [1]
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Anti-cancer activity of SENTI-202
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Assessment method [1]
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The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease
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Timepoint [1]
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Through study completion, up to 2 years
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Secondary outcome [2]
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Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202
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Assessment method [2]
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Levels of circulating SENTI-202 and peripheral cytokine levels will be measured to assess the PK/PDn profile of SENTI-202
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Timepoint [2]
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Through study completion, up to 2 years
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Secondary outcome [3]
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Host immune response to SENTI-202
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Assessment method [3]
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Anti-SENTI-202 immune response and RCR will be measured in blood samples
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Timepoint [3]
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Through study completion, up to 2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
74
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2040
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Actual
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Sample size
Target
21
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Peter MacCallum Cancer Center - Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Tennessee
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Country [5]
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United States of America
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State/province [5]
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Texas
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Senti Biosciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06325748
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Rochelle Emery, MD
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Address
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Senti Biosciences, Medical Director
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Amy Alford, MA
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Address
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Country
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Phone
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650-239-2030
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06325748
Download to PDF