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A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07198867•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

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

Detailed Description

The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (1)

Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 30, 2025

Primary Completion Date

December 30, 2026

Completion Date

December 31, 2027

Last Updated

September 30, 2025

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid Leukemia (AML)CAR-T Cell Therapy

Interventions

A-CAR028

BIOLOGICAL

Contacts

Jie Jin, MD

CONTACT

+86-0571-87236898 jiej0503@163.com

Huafeng Wang, MD

CONTACT

+86-0571-87236898 1509036@zju.edu.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

Exclusion Criteria

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