NCT07198867RecruitingPhase 1
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
Source: ClinicalTrials.gov · Last updated 30 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07198867
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 20
- From 30 Sept 2025 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- A stroke or seizure occurred within 12 months prior to signing the ICF
- Malignancy history within 5 years prior to signing the ICF
- Live vaccine injection within 4 weeks prior to signing the ICF
- Inadequate washing time for previous treatment
- Previously treated with CAR-T cell products or genetically modified T cell therapies
Other illness
- Known allergies to the components or excipients of the A-CAR028 cell product
- Uncontrolled active infection
- Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive
- Acute or chronic graft-versus-host disease (GVHD) was present at screening
Other
- Acute Promyelocytic Leukemia (APL)
- Mixed Phenotype Acute Leukemia (MPAL)
- Acute Undifferentiated Leukemia (AUL)
- Only extramedullary leukemia
- Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.