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Tests treatment safety and results for Dilated Cardiomyopathy (DCM)
Official title Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy
ClinicalTrials.gov ID: NCT07516288
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
- 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.
- Phase 1: an early, usually small safety study
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
- ≥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...
- Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and...
- Hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L.
You likely can't join if
- 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...
- Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA \>1000 copies/mL by PCR testing...
- Severe hemodynamic instability (e.g., shock).
- Known contraindications to the investigational product or study-related procedures.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang / 浙江, 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 / 浙江, 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.