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Smart immune cells take aim at tough blood cancers

NCT ID NCT06325748

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 21 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

Aug 2040

An estimate. End dates often move.

Lead sponsor

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

18 to 74 years

Sex

Anyone

Healthy volunteers

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

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

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Methodist Healthcare

    San Antonio, Texas, 78229, United States

  • Peter MacCallum Cancer Center

    Melbourne, Victoria, 3000, Australia

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050, Australia

  • TriStar Bone Marrow Transplant

    Nashville, Tennessee, 37203, United States

  • UCLA Medical Center

    Los Angeles, California, 90095, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.