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Dual-Target CAR-T therapy takes on tough leukemia

NCT ID NCT07198867

Disease control Sponsor: First Affiliated Hospital of Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new treatment called A-CAR028 for people with acute myeloid leukemia (AML) that has come back or not responded to standard therapy. A-CAR028 is a type of immune cell therapy (CAR-T) that is designed to recognize and attack leukemia cells by targeting two specific proteins. The study will enroll 20 adults aged 18 to 75 and will primarily look at safety and how well the treatment works.

What this could mean

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

Active substance
A-CAR028 (a type of CAR-T cell therapy that targets two proteins, CD33 and CLL-1, on leukemia cells)
What this could lead to
If successful, this could offer a new treatment option for people with hard-to-treat acute myeloid leukemia, potentially leading to remission.
What could go wrong
This is a very early (Phase 1) and small trial (20 people), so it may not work or could have serious side effects. CAR-T therapy can cause severe immune reactions.

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 20 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 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 75 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: * 18 to 75 years old at the time of signing the Informed Consent Form (ICF) * More than 12 weeks of expected survival * ECOG score 0 or 1 * Relapsed or refractory AML * Adequate organ function Exclusion Criteria: * Acute Promyelocytic Leukemia (APL) * Mixed Phenotype Acute Leukemia (MPAL) * Acute Undifferentiated Leukemia (AUL) * Only extramedullary leukemia * Known allergies to the components or excipients of the A-CAR028 cell product * Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure * Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF * Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression) * A stroke or seizure occurred within 12 months prior to signing the ICF * Malignancy history within 5 years prior to signing the ICF * Uncontrolled active infection * Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive * Live vaccine injection within 4 weeks prior to signing the ICF * Acute or chronic graft-versus-host disease (GVHD) was present at screening * Inadequate washing time for previous treatment * Previously treated with CAR-T cell products or genetically modified T cell therapies

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia (AML) Car-T cell therapy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.