Status:
RECRUITING
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Lead Sponsor:
First Affiliated Hospital of Zhejiang University
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
Acute Myeloid Leukemia (AML)
CAR-T Cell Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Detailed Description
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT07198867
Start Date
September 30 2025
End Date
December 31 2027
Last Update
September 30 2025
Active Locations (1)
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1
Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003