Second infusion of FAP-targeted iCDC for end-stage dilated cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase interventional trial evaluates the safety and potential benefit of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive CAR-DC cells in adults with end-stage dilated cardiomyopathy and heart failure. Eligible participants have prior infarction or prior CAR-DC exposure and currently exhibit reduced ejection fraction and advanced symptoms despite previous therapy. The study focuses on feasibility, safety signals, and preliminary efficacy by monitoring cardiac function and clinical status after the second infusion. Preclinical and prior human data suggested potential improvements in cardiac function with CAR-DC therapy and acceptable safety, guiding exploration of a second dose. Patient monitoring includes adverse events, laboratory tests, and imaging to assess changes in heart performance.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years and ≤75 years of age, with a confirmed diagnosis of dilated cardiomyopathy.
* Patients who previously received a single infusion of immunosuppressive CAR-DC (iCDC) therapy and, at 6 months after the first treatment, failed to maintain improvement in cardiac function, with cardiac function declining to baseline levels prior to treatment. These patients should have persistent heart failure symptoms that cannot be adequately improved, with left ventricular ejection fraction (LVEF) \<35%, New York Heart Association (NYHA) functional class III-IV, and INTERMACS profile 3-6.
* Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and willing to participate in the study. The participant or his/her legal representative must provide written informed consent prior to enrollment.
* Hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L.

Exclusion Criteria:

* Severe renal failure or requirement for renal dialysis, or serum creatinine \>2.5 mg/dL.
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 5.0 times the upper limit of normal (ULN), or total bilirubin \>3 mg/dL.
* Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA \>1000 copies/mL by PCR testing; Hepatitis C virus infection; Syphilis; Human immunodeficiency virus (HIV) infection; Uncontrolled systemic fungal, bacterial, viral, or other pathogenic infections.
* Severe hemodynamic instability (e.g., shock).
* Known contraindications to the investigational product or study-related procedures.

Where it's running

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

Study contacts

• Principal investigator: Xinyang Hu, PhD — Second Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Jiamin Li, MD
• Email: 21818216@zju.edu.cn
• Phone: 86-18868112006

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Monitoring progression of chronic cardiovascular conditions

  This project will collect wearable physiologic data from adults with cardiovascular conditions to see how their heart disease changes over time.

  Recruiting Prolaio · Chicago, Illinois · NCT07420907

• Endocardial delivery of stem-cell derived heart cells to help severe heart failure

  This study tests endocardial delivery of HS-001 cell sheets made from iPSC-derived cardiomyocytes in adults with severe heart failure and reduced ejection fraction to see if it is safe and may improve heart function over 26 weeks.

  Recruiting at 5 sites Phase 1/2 Heartseed Inc. · Tsukuba, Ibaraki and 4 other locations · NCT07347197

• UIC multi-ethnic dilated cardiomyopathy registry

  This project will collect genetic and social data from adults with dilated cardiomyopathy, especially African American and Hispanic/Latino patients, to see if certain genes and social factors explain worse outcomes.

  Recruiting University of Illinois Chicago · Chicago, Illinois · NCT07145138

• FAP-targeted immunosuppressive CAR-DC therapy for end-stage dilated cardiomyopathy

  Researchers are testing a new immune-cell therapy to see if it’s safe and helps people with end-stage dilated cardiomyopathy.

  Recruiting Phase 1/2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT06902896

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.