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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and < 80 years.

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

Altered mental status

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • FAP allogeneic immunosuppressive CAR-DC

    Biological/Vaccine

    Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Administration of allogeneic FAP iCDCExperimental treatment 1 intervention
Group B: Standard therapyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

The proportion of participants with DLT as assessed by CTCAE v5.0

Time frame
in 14 days after injection
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of iCDC treatment-emergent adverse events

Time frame
in 14 days after injection

Secondary outcomes

1

All-cause mortality

All-cause mortality at 30 days after iCDC treatment

Time frame
30 days after injection
2

Systolic blood pressure

Systolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.

Time frame
24 hours、48 hours、72 hours、7 days after injection
3

Diastolic blood pressure

Diastolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.

Time frame
24 hours、48 hours、72 hours、7 days after injection
4

Mean arterial pressure

The mean arterial pressure (MAP) is calculated using the following formula: MAP=DBP+1/3(SBP-DBP);DBP : Diastolic blood pressure,SBP :Systolic blood pressure

Time frame
24 hours、48 hours、72 hours、7 days after injection

Other outcomes

Sponsors and contacts

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