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Tests treatment safety and results for Dilated Cardiomyopathy (DCM)
Official title Safety and Efficacy of FAP iCDC in End-stage Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT06902896
What this study is testing
What is FAP immunosuppressive CAR-DC?
FAP immunosuppressive CAR-DC is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dilated cardiomyopathy (dcm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To study the safety and efficacy of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of end-stage dilated cardiomyopathy and provide a new method for the treatment of end-stage dilated cardiomyopathy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy.
- Able to verbally confirm that he/she understands the risks, benefits and treatment options of the iCDC trial. He/she or his/her legal representative...
- Diagnosed with Heart Failure with reduced ejection fraction (HFrEF), optimized drug therapy (under maximum tolerance of GDMT) for at least 3 months...
- Blood test: hematocrit \>30%, lymphocytes \>0.5×10\^9/L, platelets \>60×10\^9/L.
You likely can't join if
- History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment.
- CRT implanted within 12 weeks before enrollment or intended to implant CRT device.
- Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist...
- Heart failure caused by ischemic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic...
- Symptomatic bradycardia or second/third degree heart block.
- Active autoimmune disease requiring immunosuppressive therapy.
See the full eligibility criteria
- Age between 18 years old and 75 years old, diagnosed with dilated cardiomyopathy.
- Able to verbally confirm that he/she understands the risks, benefits and treatment options of the iCDC trial. He/she or his/her legal representative provides written informed consent before participating in the clinical...
- Diagnosed with Heart Failure with reduced ejection fraction (HFrEF), optimized drug therapy (under maximum tolerance of GDMT) for at least 3 months, left ventricular ejection fraction \<35%, NYHA functional class ⅢB-IV...
- Blood test: hematocrit \>30%, lymphocytes \>0.5×10\^9/L, platelets \>60×10\^9/L.
- History of myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks before enrollment.
- CRT implanted within 12 weeks before enrollment or intended to implant CRT device.
- Previous heart transplantation or implantation of a ventricular assist device or similar device, or planned implantation of a ventricular assist device or similar device.
- Heart failure caused by ischemic cardiomyopathy, restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, long-standing hypertension, congenital structural...
- Symptomatic bradycardia or second/third degree heart block.
- Active autoimmune disease requiring immunosuppressive therapy.
- Pulmonary Embolism (PE).
- A history of tuberculosis.
- History of severe renal failure or need for dialysis, creatinine \>2.5 mg/dl.
- Uncorrected thrombocytopenia or systemic coagulopathy (platelet count \ 2.5, or aPTT \> 2.5 times control in the absence of anticoagulation), or active bleeding and uncorrectable coagulopathy.
- Aspartate aminotransferase or alanine aminotransferase levels greater than 5.0 times the upper limit of normal (ULN), total bilirubin \>3 mg/dl.
- History of concurrent severe infection, hepatobiliary obstruction, or malignancy.
- Infections: Active hepatitis B (PCR-detected hepatitis B virus DNA copies \> 1000), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection at screening; uncontrolled systemic fungal, bacterial, viral, or...
- Severe hemodynamic instability (eg, shock).
- Women who are pregnant or may become pregnant.
- Contraindications to study drugs or tests.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.