Designer cells aim to calm immune system after massive heart attack

NCT ID NCT07380659

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new treatment for people in shock after a severe heart attack. The therapy uses specially engineered immune cells (CAR-DC) to target a protein found in heart scar tissue, aiming to calm the immune response. The study will enroll 18 patients and primarily check for safety and side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
genetically modified immune cells (CAR-DC) targeting a heart scar protein
What this could lead to
If it works, this could point toward a new way to reduce inflammation and improve recovery after a severe heart attack.
What could go wrong
This is a very early, small safety trial (18 people). The therapy is new and unproven; it may not help or could cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria(patients): * Age ≥ 18 years and \< 80 years. * Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions: 1. Post-emergent revascularization (PCI or CABG) 2. Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg 3. Signs of impaired organ perfusion, meeting at least one of the following criteria: 1. Altered mental status 2. Cold, clammy skin and extremities 3. Oliguria, with urine output \<30 mL/h 4. Arterial lactate level \>2 mmol/L * The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial. Exclusion Criteria(patients): 1. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation). 2. Cardiac arrest. 3. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication). 4. Shock due to other causes (e.g., sepsis, hypovolemia). 5. Resuscitation duration \>30 minutes. 6. Absence of spontaneous cardiac activity. 7. Persistent electrical instability. 8. Active bleeding or contraindications to heparin use. 9. Active autoimmune disease requiring immunosuppressive therapy. 10. History of malignancy. 11. Infection, including: * Active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or HIV infection at screening. * Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections. 12. Pregnant women. 13. Contraindications to the investigational drug or study procedures. Inclusion Criteria(donors): * Age ≥ 18 years and ≤ 75 years. * Has provided written informed consent. * Hematocrit \>30%, lymphocyte count \>0.5 × 10\^9/L, platelet count \>60 × 10\^9/L. * Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV. Exclusion Criteria(donors): * Active infection requiring treatment. * History of malignancy. * Active autoimmune disease requiring immunosuppressive therapy.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009, China

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