Smart immune cells take aim at tough blood cancers
NCT ID NCT06325748
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new therapy called SENTI-202, which uses specially designed immune cells (CAR NK cells) to find and attack cancer cells in people with certain blood cancers like acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The cells are 'off-the-shelf,' meaning they are made in a lab and ready to use without needing to be made from each patient's own cells. The study involves 21 participants and focuses on safety, dosing, and how well the therapy works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SENTI-202 (a type of immune cell therapy called CAR NK cells)
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat blood cancers like AML and MDS, using ready-made immune cells that target cancer while sparing healthy cells.
- What could go wrong
- This is a very early (Phase 1) and small trial (21 people), so safety and dosing are the main focus. The therapy may not work or could cause serious side effects, and it's too soon to know if it will help patients long-term.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 21 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Aug 2040
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 74 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
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MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Mayo Clinic
Jacksonville, Florida, 32224, United States
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Methodist Healthcare
San Antonio, Texas, 78229, United States
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Peter MacCallum Cancer Center
Melbourne, Victoria, 3000, Australia
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Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
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TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203, United States
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UCLA Medical Center
Los Angeles, California, 90095, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a p53-Targeting drug boost chemotherapy in Hard-to-Treat blood cancers?
- Can a Platelet-Boosting drug help control a rare bone marrow disorder?
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- Can a Nine-Week group program help blood cancer patients grow through trauma?
- A nationwide effort to map a rare blood Cancer's toll