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

Zhejiang University

Status and phase: Enrolling; Phase 1

Conditions: Acute Myeloid Leukemia (AML); CAR-T Cell Therapy

Treatments: Biological: A-CAR028

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07198867

1207-047

Details and patient eligibility

About

This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

A-CAR028

Experimental group

Description:

Autologous A-CAR028 administered by intravenous (IV) infusion

Treatment:

Biological: A-CAR028