Testing a Second Cell Therapy Dose for Advanced Heart Failure

Plain-English translation of NCT07516288 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated August 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 second infusion of FAP-targeted immunosuppressive CAR-DC therapy—a personalized cell treatment designed to reduce scarring in the heart and improve heart function. The study focuses on patients with severe dilated cardiomyopathy (a condition where the heart becomes enlarged and weakened) who already received one dose of this medication but saw their heart function decline again. Researchers want to know if a second dose can help restore or further improve how well the heart works.

Severe heart failure is life-threatening, and current treatment options are limited. Earlier research showed that the first dose of this treatment was safe and showed promise, but some patients' hearts weakened again over time. This study aims to find out whether giving a second dose of the medication could help patients whose hearts have deteriorated after the initial treatment.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with dilated cardiomyopathy and have severe heart failure symptoms
you received a first dose of this cell therapy at least 6 months ago and your heart function has declined back to where it started
your heart's pumping ability (ejection fraction) is below 35% and you have persistent symptoms despite standard heart failure medications
you have adequate blood cell counts and organ function (blood work within acceptable ranges)

You likely don't qualify if…

you have severe kidney disease or require dialysis
you have severe liver disease with very high liver enzyme levels
you have an active infection, including hepatitis B, hepatitis C, HIV, or uncontrolled bacterial or fungal infections
you are in severe shock or have life-threatening heart instability at the time of screening
you have known allergies or contraindications to the study treatment or procedures involved

What participation looks like

If enrolled, you would receive one intravenous infusion (IV injection) of the cell treatment at a dose that was determined to be safe and effective in earlier studies. The trial involves screening visits to confirm you meet all requirements, the infusion itself, and follow-up visits to monitor your heart function, safety, and how well the treatment is working. The study is small (only 5 participants total) and is focused on gathering preliminary safety and effectiveness data.

AI-generated summary from trial data · Aug 6, 2026 · Not medical advice

Trial locations(1 site)

China

Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang / 浙江