Safety and Efficacy of Immunosuppressive CAR-DC Targeting FAP in the Treatment of Ischemia Cardiomyopathy
New Cell Therapy Trial for Heart Damage After Heart Attack
Plain English Summary
Safety and Efficacy of FAP iCDC in Ischemia Cardiomyopathy is a Phase 1 clinical trial sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University studying Ischemic Cardiomyopathy, Cell Therapy. This trial tests a new cell therapy designed to help the heart recover after damage from a heart attack. It is for adults with a specific type of heart muscle weakness called ischemic cardiomyopathy. Participants will receive an infusion of their own modified cells, and will be monitored for side effects and heart function. Current treatments focus on managing symptoms and preventing further damage, but this therapy aims to repair the heart muscle itself. The trial aims to enroll 15 participants.
Official Summary
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted autologus immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of ischemic cardiomyopathy, aiming to provide a novel therapeutic strategy for the disease.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 to 75 with diagnosed ischemic cardiomyopathy who have had their condition for at least 3 months and are on standard heart medications. Patients must have a weakened heart pump (left ventricular ejection fraction below 35%) and experience significant limitations in daily activities (NYHA class III-IV). Individuals with a life expectancy less than 1 year, recent heart procedures, other types of heart muscle disease, severe kidney disease, active autoimmune diseases, or active infections cannot participate. Pregnant women are also excluded from this study. This trial is studying Ischemic Cardiomyopathy, Cell Therapy, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the new cell therapy is by tracking any serious side effects and overall adverse events within the first 14 days and 6 months after treatment. The specific primary outcome measures are: Incidence of Dose-Limiting Toxicities (DLT) (Within 14 days after treatment); Incidence of Treatment-Emergent Adverse Events (TEAE) (Within 6 months after treatment). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a significant unmet need in treating ischemic cardiomyopathy, a condition where heart damage from reduced blood flow leads to heart failure, by exploring a novel cell therapy to p This research targets Ischemic Cardiomyopathy, Cell Therapy, where improved treatment options are needed.
Investor Insight
This Phase 1 trial represents an early-stage investment in a potentially groundbreaking cell therapy for a large patient population, with a high unmet need and limited regenerative treatment options, Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the specific risks and benefits of this experimental cell therapy and how it compares to standard treatments. Understand that participation involves receiving an infusion of modified cells and regular follow-up appointments for monitoring. Be prepared for potential side effects and the need for ongoing medical assessments over several months. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 15 participants
Interventions
- BIOLOGICAL: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) — Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
Primary Outcomes
- Incidence of Dose-Limiting Toxicities (DLT) (Within 14 days after treatment)
- Incidence of Treatment-Emergent Adverse Events (TEAE) (Within 6 months after treatment)
Secondary Outcomes
- Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography (Baseline, 3 months, 6 months, and 12 months)
- Change in Left Ventricular Ejection Fraction as assessed by Cardiac MRI (Baseline, 6 months, and 12 months)
- Change in Myocardial Late Gadolinium Enhancement Volume by CMR (Baseline, 6 months, and 12 months)
- Change in left ventricular end-systolic diameter measured by Echocardiography (Baseline, 3 months, 6 months, and 12 months)
- Change in left ventricular end-diastolic diameter measured by Echocardiography (Baseline, 3 months, 6 months, and 12 months)
Full Eligibility Criteria
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. 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 \<15 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.
Frequently Asked Questions
What is clinical trial NCT07505199?
NCT07505199 is a Phase 1 INTERVENTIONAL study titled "Safety and Efficacy of FAP iCDC in Ischemia Cardiomyopathy." It is currently not yet recruiting and is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial targets enrollment of 15 participants.
What conditions does NCT07505199 study?
This trial investigates treatments for Ischemic Cardiomyopathy, Cell Therapy. The primary condition under study is Ischemic Cardiomyopathy.
What treatments are being tested in NCT07505199?
The interventions being studied include: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) (BIOLOGICAL). Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
What does Phase 1 mean for NCT07505199?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT07505199?
This trial is currently "Not Yet Recruiting." It started on 2026-04-01. The estimated completion date is 2029-04-01.
Who is sponsoring NCT07505199?
NCT07505199 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07505199?
The trial aims to enroll 15 participants. The trial has not yet started recruiting.
How is NCT07505199 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07505199?
The primary outcome measures are: Incidence of Dose-Limiting Toxicities (DLT) (Within 14 days after treatment); Incidence of Treatment-Emergent Adverse Events (TEAE) (Within 6 months after treatment). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07505199?
The official record for NCT07505199 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07505199. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07505199 testing in simple terms?
This trial tests a new cell therapy designed to help the heart recover after damage from a heart attack. It is for adults with a specific type of heart muscle weakness called ischemic cardiomyopathy.
Why is this trial significant?
This trial addresses a significant unmet need in treating ischemic cardiomyopathy, a condition where heart damage from reduced blood flow leads to heart failure, by exploring a novel cell therapy to p
What are the potential risks of participating in NCT07505199?
The main risks involve potential side effects from the cell therapy, such as infusion reactions or unexpected immune responses. Other risks include the possibility of the therapy not being effective or causing new heart problems. Close monitoring will be in place to detect and manage any adverse events. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07505199?
Ask your doctor about the specific risks and benefits of this experimental cell therapy and how it compares to standard treatments. Understand that participation involves receiving an infusion of modified cells and regular follow-up appointments for monitoring. Be prepared for potential side effects and the need for ongoing medical assessments over several months. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07505199 signal from an investment perspective?
This Phase 1 trial represents an early-stage investment in a potentially groundbreaking cell therapy for a large patient population, with a high unmet need and limited regenerative treatment options, This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will receive an infusion of their own modified cells, and will be monitored for side effects and heart function. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.