AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy

RecruitingPhase 1Ages 18 Years - 75 YearsAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy. Previous clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ18 years and โ‰ค75 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 ร— 10โน/L, and platelet count \>60 ร— 10โน/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.
๐Ÿ’Š

What it tests

  • FAP immunosuppressive CAR-DC
๐Ÿ“

Where

1 site
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy