AML/MDSPhase 1NCT06325748
SENTI-202: Off-the-shelf Logic Gated CAR NK Cell Therapy in Adults With CD33 and/or FLT3 Blood Cancers Including AML/MDS
A Phase 1 study testing SENTI-202 in people with AML/MDS and CD33 Expressing Hematological Malignancies, run by Senti Biosciences at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- AML/MDS, CD33 Expressing Hematological Malignancies, FLT3 Expressing Hematological Malignancies
- What is being tested?
- SENTI-202
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 22 Apr 2024to Aug 2040
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States6 sites
Colorado Blood Cancer Institute
Denver, Colorado, 80218
MD Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
UCLA Medical Center
Los Angeles, California, 90095
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
Methodist Healthcare
San Antonio, Texas, 78229
Australia2 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Peter MacCallum Cancer Center
Melbourne, Victoria, 3000
About this study
Official 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 Malignancies
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.
Read the detailed description
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).
- Conditions
- AML/MDS, CD33 Expressing Hematological Malignancies, FLT3 Expressing Hematological Malignancies
- Being tested
- SENTI-202
- Keywords
- SENTI-202, CAR NK, natural killer cell, CD33, FLT3, allogeneic, logic gate, relapsed/refractory AML, relapsed/refractory MDS, inhibitory CAR, activating CAR, NOT logic gate, IL15, interleukin 15, cell therapy, off-the-shelf, leukemic stem cells, blastic plasmacytoid dendritic cell neoplasm (BPDCN), multiple myeloma (MM), mixed phenotype acute leukemia (MPAL)
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence, Blastic Plasmacytoid Dendritic Cell Neoplasm, Multiple Myeloma, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENTI-202Biological
Also called Fludarabine, Cytarabine (ara-C)
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 either a 3 dose regimen (Schedule 1: Days 0, 7, 14) or a 5 dose regimen (Schedule 2: Days 0, 3, 7, 10, 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 to achieve optimal response with the optionality of an additional consolidation cycle thereafter. Additional dosing schedules may be explored depending on study data.
| Study group | Role | What they receive |
|---|---|---|
| SENTI-202 CAR NK cell therapy | Experimental | 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 Receives: Biological: SENTI-202 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years
For subjects enrolled in the Dose Expansion Cohort(s): 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
Measured: Through study completion, up to 2 years
Secondary outcomes (3)
For subjects enrolled in the Dose Finding Cohorts: 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
Measured: 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
Measured: 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
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start22 Apr 2024
- Primary completionFeb 2026 (estimated)
- Study completionAug 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML/MDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Senti Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rochelle Emery, MD, Study director, Senti Biosciences, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06325748
- Sponsor's protocol ID
- SENTI-202-101
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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 Malignancies
- ClinicalTrials.gov ID
- NCT06325748
- Acronym / sponsor ID
- SENTI-202-101
- Conditions
- AML/MDS, CD33 Expressing Hematological Malignancies, FLT3 Expressing Hematological Malignancies
- Keywords
- SENTI-202, CAR NK, natural killer cell, CD33, FLT3, allogeneic, logic gate, relapsed/refractory AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Senti BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Aug 2040 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENTI-202 CAR NK cell therapy | Experimental | Biological: SENTI-202Part 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 |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects with CD33 and/or FLT3 expressing malignancies, including:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SENTI-202Also: Fludarabine, Cytarabine (ara-C)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 either a 3 dose regimen (Schedule 1: Days 0, 7, 14) or a 5 dose regimen (Schedule 2: Days 0, 3, 7, 10, 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 to achieve optimal response with the optionality of an additional consolidation cycle thereafter. Additional dosing schedules may be explored depending on study data. | Biological | SENTI-202 CAR NK cell therapy |
Primary outcome
Safety and tolerability for dose determination of SENTI-202
Time frame: At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years
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
For subjects enrolled in the Dose Expansion Cohort(s): Anti-cancer activity of SENTI-202
Time frame: Through study completion, up to 2 years
The response rate to SENTI-202 will be measured using clinical measures of benefit as defined by standard consensus criteria for the respective disease
3 secondary outcomes
For subjects enrolled in the Dose Finding Cohorts: Anti-cancer activity of SENTI-202
Time frame: Through study completion, up to 2 years
Pharmacokinetic (PK) and pharmacodynamic (PDn) profile of SENTI-202
Time frame: Through study completion, up to 2 years
Host immune response to SENTI-202
Time frame: Through study completion, up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
Related trials for AML/MDS
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
RecruitingObservational study
HPC Offered for PRESERVE Expansion
Bone Marrow Transplant (BMT)
RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
R/R AML, R/R HR-MDS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rochelle Emery, MD study director
Senti Biosciences, Medical Director
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SENTI-202 in people with AML/MDS and CD33 Expressing Hematological Malignancies, run by Senti Biosciences at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability for dose determination of SENTI-202 (time frame: At the end of each treatment cycle (each cycle is 28 days) and through study completion, up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.