RecruitingPhase 1NCT07198867

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

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

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

20 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

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

BIOLOGICALA-CAR028

A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens

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

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07198867