Actively Recruiting

Phase 1
Phase 2
Age: 6Months - 75Years
All Genders
NCT04010877

Multiple CAR-T Cell Therapy Targeting AML

Led by Shenzhen Geno-Immune Medical Institute · Updated on 2026-04-24

10

Participants Needed

1

Research Sites

230 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of multiple CAR T-cell therapy which combines CAR T cells against CLL-1 with CAR T cells targeting CD123 or CD33 in patients with relapsed and refractory AML. The study also aims to learn more about the function of CAR T cells and their persistency in AML patients.

CONDITIONS

Official Title

Multiple CAR-T Cell Therapy Targeting AML

Who Can Participate

Age: 6Months - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age older than 6 months
  • Confirmed expression of CLL-1, CD123 and/or CD33 in blast AML by immuno-histochemical staining or flow cytometry
  • Karnofsky performance status (KPS) score higher than 80 and life expectancy greater than 3 months
  • Adequate bone marrow, liver, and kidney function including cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 times upper limit of normal, AST and ALT ≤ 3 times upper limit of normal, total bilirubin ≤ 2.0 mg/dL
  • Hemoglobin (Hgb) ≥ 80 g/L
  • No contraindications for cell separation
  • Ability to understand and willingness to provide written informed consent
Not Eligible

You will not qualify if you...

  • Severe illness or medical condition preventing protocol management, including active uncontrolled infection
  • Active bacterial, fungal, or viral infection not controlled by adequate treatment
  • Known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
  • Pregnant or nursing women
  • Use of systemic glucocorticoids within one week prior to trial entry
  • Previous treatment with any gene therapy products
  • Inability to comply with study requirements as judged by investigators

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

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

L

Lung-Ji Chang, Ph.D

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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