A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
NCT ID: NCT07198867
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
20 participants
INTERVENTIONAL
2025-09-30
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With R/R AML
NCT05463640
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
NCT06762132
A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
NCT04532281
Evaluate the Safety and Efficacy of CD33 CAR-T in Patients With R/R AML
NCT05473221
Safety and Efficacy of Anti-CD123 CAR-T Therapy in Patients With Refractory/ Relapsed CD123+ Acute Myeloid Leukemia.
NCT04014881
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A-CAR028
Autologous A-CAR028 administered by intravenous (IV) infusion
A-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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
A-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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* More than 12 weeks of expected survival
* ECOG score 0 or 1
* Relapsed or refractory AML
* Adequate organ function
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai AbelZeta Ltd.
INDUSTRY
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Huafeng Wang, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1207-047
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.