Not Yet RecruitingPhase 1

Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock

China18 participantsStarted 2026-01-20

Plain-language summary

To study the safety and efficacy of fibroblast activation protein (FAP)-targeted allogeneic immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of acute myocardial infarction with cardiogenic shock and provide a new method for the treatment of acute myocardial infarction with cardiogenic shock.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Post-emergent revascularization (PCI or CABG)
✓. Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg
✓. Signs of impaired organ perfusion, meeting at least one of the following criteria:
✓. Altered mental status
✓. Cold, clammy skin and extremities
✓. Oliguria, with urine output \<30 mL/h
✓. Arterial lactate level \>2 mmol/L

Exclusion criteria

✕. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
✕. Cardiac arrest.
✕. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
✕. Shock due to other causes (e.g., sepsis, hypovolemia).
✕. Resuscitation duration \>30 minutes.
✕. Absence of spontaneous cardiac activity.
✕. Persistent electrical instability.

What they're measuring

The proportion of subjects with Dose-limiting toxicity (DLT)

Timeframe: in 14 days after injection

Incidence of treatment-emergent adverse events (TEAEs)

Timeframe: in 14 days after injection

Trial details

NCT IDNCT07380659

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-30

Contact for this trial

Jiamin Li, MD

86-18868112006 21818216@zju.edu.cn

View on ClinicalTrials.gov More Cardiogenic Shock trials