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

Recruiting now · Phase 1

Conditions studied: Acute Myeloid Leukemia (AML), CAR-T Cell Therapy

In brief

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

Key facts

Study ID

NCT07198867

Run by

First Affiliated Hospital of Zhejiang University

People needed

20

Starts

2025-09-30

Expected to finish

2027-12-31

Last updated by the study team

2025-09-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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