Engineered immune cells aim to repair damaged hearts
NCT ID NCT07505199
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This early-stage trial tests a new cell therapy for people with heart failure caused by blocked arteries. The treatment uses the patient's own immune cells, engineered to target scar tissue in the heart. The study will check safety and whether it can improve heart function in 15 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FAP-targeted immunosuppressive CAR-DC cells (iCDC)
- What this could lead to
- If it works, this could point toward a new treatment for heart failure caused by blocked arteries, potentially improving heart function.
- What could go wrong
- This is a very early Phase 1 trial with only 15 people, so it is mainly checking safety. The treatment may not improve heart function, and there could be side effects from the cell infusion.
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 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 75 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: * Age ≥18 years and ≤75 years. * Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) \<35%; New York Heart Association (NYHA) functional class III-IV. * Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his/her legally authorized representative must provide written informed consent prior to study enrollment. * Adequate hematologic function defined as: hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L. Exclusion Criteria: * Life expectancy \<1 year due to non-cardiac conditions. Cardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation. Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI. Presence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies. Persistent hemodynamic instability. End-stage renal disease (eGFR \<25 mL/min/1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis). Active autoimmune disease requiring immunosuppressive therapy. History of malignancy. Active infection, including but not limited to active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections. Pregnant women. Known contraindications to the investigational product or study-related procedures.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang / 浙江, 310009, China
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