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Taking people in ChinaPhase 1

Tests A-CAR028 cell therapy in adults with returning or resistant acute myeloid leukemia

Tests A-CAR028 cell therapy in adults with returning leukemia.

Plain-language title generated from the registry record
Registry title: A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Key facts

Where
Hangzhou, ChinaSee the site
Phase
Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 whose acute myeloid leukemia (AML) has come back or has not responded to treatment. They will receive a cell therapy called A-CAR028.

Age
18 to 75 years
Sex
Men and women can both join.
Disease stage
Acute myeloid leukemia that has relapsed (come back) or is refractory (did not respond to treatment).
Earlier treatment
People who had CAR-T cell products or other genetically modified T cell therapy cannot join. A stem cell transplant within 3 months before signing consent is not allowed. Enough time must have passed since earlier treatments.

Main reasons for not taking part

  • Acute promyelocytic leukemia, mixed phenotype acute leukemia or acute undifferentiated leukemia
  • Leukemia only outside the bone marrow, or involvement of the central nervous system (brain and spinal cord)
  • Severe heart disease, or a stroke or seizure within 12 months
  • Uncontrolled infection, or positive tests for hepatitis B, hepatitis C, HIV, syphilis or CMV DNA
  • Another cancer within the past 5 years

Read by machine on 12 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Source: NCT07198867, who can take part

Where in China

  • Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaContact: Jie Jin, MDTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
First Affiliated Hospital of Zhejiang University
Trial code
NCT07198867
Record updated
30 September 2025
Original description
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patientsRead full original descriptionShow less

A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients

Inclusion: 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: 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; A stroke or seizure occurred within 12 months prior to signing the ICF; Malignancy history within 5 years prior to signing the ICF; Live vaccine injection within 4 weeks prior to signing the ICF; Inadequate washing time for previous treatment; Previously treated with CAR-T cell products or genetically modified T cell therapies; Known allergies to the components or excipients of the A-CAR028 cell product; Uncontrolled active infection; Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive; Acute or chronic graft-versus-host disease (GVHD) was present at screening; Acute Promyelocytic Leukemia (APL); Mixed Phenotype Acute Leukemia (MPAL); Acute Undifferentiated Leukemia (AUL); Only extramedullary leukemia; Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression).

ClinicalTrials.gov NCT07198867