Actively Recruiting
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-30
20
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
Shanghai AbelZeta Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
CONDITIONS
Official Title
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of signing the informed consent
- Expected survival longer than 12 weeks
- ECOG performance status score of 0 or 1
- Diagnosis of relapsed or refractory acute myeloid leukemia
- Adequate organ function
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL), mixed phenotype acute leukemia (MPAL), or acute undifferentiated leukemia (AUL)
- Leukemia only outside the bone marrow (extramedullary leukemia)
- Known allergy to components or excipients of A-CAR028
- Severe heart conditions such as recent myocardial infarction, unstable angina, severe arrhythmia, cardiomyopathy, or heart failure
- Stem cell transplantation within 3 months prior to consent
- Central nervous system involvement or symptoms including cranial nerve lesions or spinal cord compression
- Stroke or seizure within 12 months prior to consent
- History of cancer within 5 years prior to consent
- Uncontrolled active infection
- Positive tests for HBV, HCV, HIV, Treponema Pallidum, or CMV DNA
- Live vaccine within 4 weeks prior to consent
- Presence of acute or chronic graft-versus-host disease at screening
- Insufficient washout period from previous treatments
- Prior treatment with CAR-T cell products or genetically modified T cell therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
J
Jie Jin, MD
CONTACT
H
Huafeng Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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