Skip to content
TrialMatch
Sign up
Recruiting Phase 1

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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

Condition
Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
Tested
A-CAR028
Sponsor
First Affiliated Hospital of Zhejiang University

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
  • 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 16

  • 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

1 site, 1 recruiting

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

Hangzhou, Zhejiang, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.