Testing a new immune-based treatment for hard-to-treat blood cancers

Plain-English translation of NCT05143996 on ClinicalTrials.gov ↗ · Source last updated January 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a new medication called , which works by helping your own immune cells (called T cells) recognize and attack leukemia or myelodysplastic syndrome cells. Researchers want to find the right dose and understand how safe this treatment is in patients whose cancer has come back or stopped responding to standard therapies. The study will test the medication given either as an injection under the skin or through an IV (intravenous) infusion, with doses given weekly.

Patients with relapsed or hard-to-treat acute myeloid leukemia and myelodysplastic syndrome have very limited options, and current treatments often don't work well enough. This trial exists to see whether this new immune-based approach might offer hope to patients who have run out of other treatment choices.

Do you qualify?

You likely qualify if…

you are 18 years of age or older
you have been diagnosed with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndrome
your cancer has progressed, come back, or you could not tolerate standard treatments available to you
you have an Eastern Cooperative Oncology Group performance status of 0 to 2 (meaning you are able to do light activities or care for yourself)
your kidney function and liver function are acceptable based on blood tests, and your white blood cell count is controlled

You likely don't qualify if…

you have a specific type of leukemia called acute promyelocytic leukemia
you have active leukemia in your central nervous system or brain
you had an organ transplant in the past or a bone marrow transplant within the last six months
you received radiation therapy to your brain or spine within the past 8 weeks, or had total body radiation
you have received CAR-T cell therapy or other modified T cell therapies in the past

What participation looks like

You will join one of three study groups. In some groups, you will receive one dose or weekly doses of the medication through an IV or as an injection under your skin over several weeks. You will have frequent clinic visits during the first 28 days to have blood tests and safety checks, and then continued follow-up visits for up to 2 years to monitor how you are doing. Bone marrow and blood samples will be collected to track how your disease responds to the treatment.

AI-generated summary from trial data · Jun 12, 2026 · Not medical advice

Trial locations(11 sites)

United States

University of Alabama O'Neal Cancer Center, Birmingham, Alabama

UCLA, Los Angeles, California

University of Miami Health System, Miami, Florida

Moffitt Cancer Center, Tampa, Florida

Emory University Hospital, Atlanta, Georgia