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
52 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
Researchers are evaluating the safety and effectiveness of A-CAR028, a new 2nd generation CAR-T cell therapy that targets CD33 and CLL-1 antigens, in patients with relapsed or refractory acute myeloid leukemia (AML). This phase 1, open-label study is conducted at a single center and sponsored by the First Affiliated Hospital of Zhejiang University. The trial aims to better understand how this treatment works and its potential risks in this specific patient group. The study involves several steps: screening to confirm eligibility, collecting immune cells through apheresis to create the personalized A-CAR028 therapy, baseline testing, lymphodepletion to prepare the body, and then intravenous infusion of A-CAR028. After the infusion, participants are monitored closely for dose-limiting toxicities during the first 28 days, followed by ongoing observation of treatment-related adverse events for up to three months and further follow-up lasting two years. This process helps evaluate both short- and long-term safety and response to the treatment. Participants will undergo regular assessments including safety checks, laboratory tests, and evaluations of leukemia response using bone marrow samples and blood tests. Researchers will track adverse events, response rates, survival, and pharmacokinetic measures such as drug concentration over time. The study spans from screening through a two-year follow-up period after infusion, ensuring thorough observation of treatment impact and patient health throughout the trial.
CONDITIONS
Brief 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 form
- Expected survival of more than 12 weeks
- ECOG performance status of 0 or 1
- Diagnosis of relapsed or refractory acute myeloid leukemia
- Adequate organ function
You will not qualify if you...
- Acute Promyelocytic Leukemia (APL), Mixed Phenotype Acute Leukemia (MPAL), or Acute Undifferentiated Leukemia (AUL)
- Leukemia only outside the bone marrow (extramedullary only)
- Known allergies to components of the A-CAR028 product
- Severe heart diseases such as recent myocardial infarction, unstable angina, severe arrhythmia, or heart failure
- Stem cell transplantation within 3 months prior to consent
- Central nervous system involvement or symptoms
- Stroke or seizure within 12 months prior to consent
- History of malignancy 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 graft-versus-host disease at screening
- Inadequate washout time from previous treatments
- Prior treatment with CAR-T or genetically modified T cell therapies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration depends on manufacturing process
Participants undergo apheresis to collect cells for manufacturing the A-CAR028 treatment.
1 to 2 visits for apheresis and collection
Duration - A few days prior to lymphodepletion
Participants undergo baseline assessments before starting lymphodepletion.
1 visit (in-person)
Duration - Several days
Participants receive lymphodepleting treatment to prepare for A-CAR028 infusion.
Daily visits during lymphodepletion
Duration - 1 day for infusion plus 28 days of dose-limiting toxicity observation
Participants receive a single intravenous infusion of A-CAR028.
1 infusion visit followed by frequent visits during 28-day observation
Duration - Up to 2 years
Participants are monitored for adverse events and treatment response up to 2 years after infusion.
Regular visits during the first 3 months, then periodic visits up to 2 years
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
H
Huafeng Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here