Testing new immune cells for hard-to-treat blood cancer

Plain-English translation of NCT06760260 on ClinicalTrials.gov ↗ · Source last updated January 2025 · 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 is an early-stage trial testing a new treatment called CI-135 CAR-T Cell Injection for people with acute myeloid leukemia (AML) that has come back or stopped responding to standard chemotherapy. The treatment uses your own immune cells that are grown in a laboratory and specially programmed to recognize and attack leukemia cells. This medication is given as a single infusion into your bloodstream.

Standard chemotherapy doesn't work well enough for some patients with AML, and many people relapse after initial treatment. This new treatment offers a different approach by using the body's own immune system to fight the cancer, which may help patients who have limited options left.

Do you qualify?

You likely qualify if…

you are 18 to 70 years old
you have been diagnosed with acute myeloid leukemia that has either not responded to chemotherapy or has come back after treatment
your leukemia cells have a specific genetic change called FLT3 mutation or high FLT3 expression
you are expected to live at least 12 weeks
your heart, lungs, liver, and kidneys are working well enough to tolerate the treatment
you have not previously received CAR-T cell therapy or other gene-modified cell treatments

You likely don't qualify if…

you have a specific type of leukemia called acute promyelocytic leukemia (APL)
you have other active cancers that are not controlled
you have serious heart problems, such as congestive heart failure or dangerous irregular heartbeats
you have untreated hepatitis B infection
you are not able to understand the study details or give informed consent

What participation looks like

You will receive a single infusion of the specially designed immune cells at the trial center. The doctors will monitor you closely to watch how your body responds to the treatment and whether it helps control your leukemia. You will have blood tests, imaging scans, and heart function tests at various time points to check your safety and how well the treatment is working. This is a very early-stage trial with only about 7 participants, so the research team will be carefully watching for any side effects.

AI-generated summary from trial data · Jun 18, 2026 · Not medical advice

Trial locations(1 site)

China

First Affiliated Hospital of Soochow University, Suzhou, Jiangsu