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RecruitingNCT07198867Updated Sep 30, 2025

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

A Phase 1 interventional study of A-CAR028 in Acute Myeloid Leukemia (AML) and CAR-T Cell Therapy, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-30.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Acute Myeloid Leukemia (AML)
  • CAR-T Cell Therapy

Keywords

  • A-CAR028
  • Acute Myeloid Leukemia
03

In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    A-CAR028

    Autologous A-CAR028 administered by intravenous (IV) infusion

    Biological: A-CAR028

Interventions

  • BiologicalA-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

06

What researchers measure

Primary outcomes

  1. Incidence of dose limiting toxicities (DLTs)

    Time frame: Throughout the 28 days post A-CAR028 infusion

  2. Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Throughout the 3 months post A-CAR028 infusion

Secondary outcomes

  1. Incidence and severity of Adverse Events (AEs)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  2. 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

  3. Duration of Response (DOR)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  4. Event-free Survival (EFS)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  5. Overall Survival (OS)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  6. Maximal plasma concentration (Cmax)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  7. Time to reach the maximal plasma concentration (Tmax)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  8. Area under the curve within 28 days (AUC0-28d)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  9. Time of last measurable observed concentration (Tlast)

    Time frame: Throughout the 2 years post A-CAR028 infusion

  10. Changes of CD33/CLL-1 positive cells in bone marrow

    Time frame: Throughout the 2 years post A-CAR028 infusion

07

Study locations

1 of 1 sites recruiting
  • Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang 310003, China
    • Jie Jin, MD · Contact · jiej0503@163.com · +86-571-87236114
    • Huafeng Wang, MD · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07198867
Lead sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Shanghai AbelZeta Ltd.
Responsible party
Sponsor
First posted
Sep 30, 2025
Start date
Sep 30, 2025 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 30, 2025

Study contacts

Jie Jin, MD
Contact
jiej0503@163.com
+86-0571-87236898
Huafeng Wang, MD
Contact
1509036@zju.edu.cn
+86-0571-87236898

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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