NCT07198867

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
20mo left

Started Sep 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

July 30, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 30, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

July 30, 2025

Last Update Submit

September 22, 2025

Conditions

Acute Myeloid Leukemia (AML)CAR-T Cell Therapy

Keywords

A-CAR028Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • Incidence of dose limiting toxicities (DLTs)

    Throughout the 28 days post A-CAR028 infusion

  • Incidence and severity of Treatment Emergent Adverse Events (TEAEs)

    Throughout the 3 months post A-CAR028 infusion

Secondary Outcomes (10)

  • Incidence and severity of Adverse Events (AEs)

    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)

    Throughout the 2 years post A-CAR028 infusion

  • Duration of Response (DOR)

    Throughout the 2 years post A-CAR028 infusion

  • Event-free Survival (EFS)

    Throughout the 2 years post A-CAR028 infusion

  • Overall Survival (OS)

    Throughout the 2 years post A-CAR028 infusion

  • +5 more secondary outcomes

Study Arms (1)

A-CAR028

EXPERIMENTAL

Autologous A-CAR028 administered by intravenous (IV) infusion

Biological: A-CAR028

Interventions

A-CAR028BIOLOGICAL

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

A-CAR028

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Jie Jin, MD

CONTACT

+86-0571-87236898jiej0503@163.com

Huafeng Wang, MD

CONTACT

+86-0571-872368981509036@zju.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2025

First Posted

September 30, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

September 30, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)