Phase 1 Cardiomyopathy Trial, Recruiting NCT07516288 Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Condition: Cardiomyopathy
Back to Cardiomyopathy

Phase 1 Cardiomyopathy Trial, Recruiting

NCT07516288
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are aged 18 to 75 years old and have been diagnosed with dilated cardiomyopathy (a condition where the heart becomes enlarged and cannot pump blood properly)
  • People who previously received a single infusion of a specific immune-modifying cell therapy called iCDC, and whose heart function improved at first but then declined back to pre-treatment levels by 6 months after that first treatment
  • People whose heart is still not pumping well enough, specifically with a heart pumping strength (LVEF) below 35%, significant heart failure symptoms rated as Class III or IV on a standard medical scale, and a disease severity rating falling within a specific middle range on another standard heart failure scale (INTERMACS profile 3–6)
  • People who are able to verbally show they understand the risks, benefits, and other treatment options, and are willing to take part; either the person themselves or their legal representative must sign a written consent form before enrolling
  • People whose blood test results meet minimum thresholds for red blood cell percentage, a type of white blood cell count, and platelet count (confirm with trial site for exact values)

Who may not be able to join:

  • People with severe kidney failure, those currently on kidney dialysis, or those with a specific blood marker for kidney function above a certain level
  • People with significantly elevated liver enzyme levels or a liver-related blood marker above a certain threshold, which may suggest liver damage
  • People with certain active infections at the time of screening, including active hepatitis B with a detectable virus level above a set amount, hepatitis C, syphilis, HIV, or any other serious uncontrolled infection caused by fungus, bacteria, viruses, or other organisms
  • People experiencing severe instability in how the heart is pumping blood around the body, such as being in shock
  • People with known reasons they should not receive the study treatment or undergo the study procedures

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Xinyang Hu, PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University, China

Phone: 86-18868112006

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
11 May 2026
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The proportion of subjects with Dose-limiting toxicity (DLT); Incidence of treatment-emergent adverse events (TEAEs)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov