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Recruiting NCT07198867

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

Phase I Interventional Acute Myeloid Leukemia (AML) CAR-T Cell Therapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A-CAR028.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia (AML), CAR-T Cell Therapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Biological A-CAR028
    A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens

Primary outcome measures

  • Incidence of dose limiting toxicities (DLTs) [Time frame: Throughout the 28 days post A-CAR028 infusion]
  • Incidence and severity of Treatment Emergent Adverse Events (TEAEs) [Time frame: Throughout the 3 months post A-CAR028 infusion]
Secondary outcome measures (10)
  • Incidence and severity of Adverse Events (AEs) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Duration of Response (DOR) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Event-free Survival (EFS) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Overall Survival (OS) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Maximal plasma concentration (Cmax) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Time to reach the maximal plasma concentration (Tmax) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Area under the curve within 28 days (AUC0-28d) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Time of last measurable observed concentration (Tlast) [Time frame: Throughout the 2 years post A-CAR028 infusion]
  • Changes of CD33/CLL-1 positive cells in bone marrow [Time frame: Throughout the 2 years post A-CAR028 infusion]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang Univ — Hangzhou

Identifiers

NCT: NCT07198867 · 1207-047

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗