NCT07198867 A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
| NCT ID | NCT07198867 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2025-09-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07198867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07198867 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07198867 currently recruiting?
Yes, NCT07198867 is actively recruiting participants. Contact the research team at jiej0503@163.com for enrollment information.
Where is the NCT07198867 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07198867 clinical trial?
NCT07198867 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.