A-CAR028 for relapsed or refractory acute myeloid leukemia
A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
This study will try A-CAR028, a CAR-T cell therapy, in adults with relapsed or refractory AML to see if it is safe and helps control the leukemia.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT07198867 on ClinicalTrials.gov |
What this trial studies
This is a single-center, open-label Phase 1 study testing A-CAR028 in adults with relapsed or refractory acute myeloid leukemia. Eligible participants undergo screening, leukapheresis for collection of their T cells, manufacturing of the A-CAR028 product, baseline testing, lymphodepleting chemotherapy, and a single A-CAR028 infusion followed by dose-limiting toxicity observation and scheduled follow-up visits. The primary focus is on safety and tolerability, with secondary measures of anti-leukemia activity and durability of response. The study is conducted at the First Affiliated Hospital, School of Medicine, Zhejiang University, with collaboration from Shanghai AbelZeta Ltd.
Who should consider this trial
Good fit: Adults aged 18–75 with relapsed or refractory AML, ECOG 0–1, adequate organ function, and expected survival beyond 12 weeks are the intended participants.
Not a fit: Patients with acute promyelocytic leukemia, mixed phenotype or undifferentiated leukemia, only extramedullary disease, CNS involvement, recent transplant, severe cardiac disease, or known allergies to the product components are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, A-CAR028 could produce remissions or longer disease control in some patients with relapsed or refractory AML who have limited treatment options.
How similar studies have performed: CAR-T approaches in AML are experimental and have shown only limited and early signals of benefit to date, so this approach remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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 this trial is running
Hangzhou, Zhejiang
- Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jie Jin, MD
- Email: jiej0503@163.com
- Phone: +86-0571-87236898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.