Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT07198867

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2025-09-30

20

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

S

Shanghai AbelZeta Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years at the time of signing the informed consent
  • Expected survival longer than 12 weeks
  • ECOG performance status score of 0 or 1
  • Diagnosis of relapsed or refractory acute myeloid leukemia
  • Adequate organ function
Not Eligible

You will not qualify if you...

  • Diagnosis of acute promyelocytic leukemia (APL), mixed phenotype acute leukemia (MPAL), or acute undifferentiated leukemia (AUL)
  • Leukemia only outside the bone marrow (extramedullary leukemia)
  • Known allergy to components or excipients of A-CAR028
  • Severe heart conditions such as recent myocardial infarction, unstable angina, severe arrhythmia, cardiomyopathy, or heart failure
  • Stem cell transplantation within 3 months prior to consent
  • Central nervous system involvement or symptoms including cranial nerve lesions or spinal cord compression
  • Stroke or seizure within 12 months prior to consent
  • History of cancer within 5 years prior to consent
  • Uncontrolled active infection
  • Positive tests for HBV, HCV, HIV, Treponema Pallidum, or CMV DNA
  • Live vaccine within 4 weeks prior to consent
  • Presence of acute or chronic graft-versus-host disease at screening
  • Insufficient washout period from previous treatments
  • Prior treatment with CAR-T cell products or genetically modified T cell therapies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Hangzhou, Zhejiang, China, 310003

Actively Recruiting

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Research Team

J

Jie Jin, MD

CONTACT

H

Huafeng Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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