Actively Recruiting
Universal CAR-T Cells Targeting AML
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2023-10-12
30
Participants Needed
1
Research Sites
165 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 universal CAR T-cell products targeting CLL-1, CD33, CD38 and CD123 in patients with relapsed and refractory AML. The study also aims to learn more about the function of the universal CAR T cells and their persistency in AML patients.
CONDITIONS
Official Title
Universal CAR-T Cells Targeting AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 6 months
- Confirmed expression of CLL-1, CD123, CD38 and/or CD33 in AML blasts 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 level ≥ 80 g/L
- No contraindications for cell separation
- Ability to understand and willingness to provide written informed consent
You will not qualify if you...
- Severe illness or medical condition preventing patient management according to the protocol, including active uncontrolled infection
- Active bacterial, fungal or viral infection not controlled by adequate treatment
- Known HIV or active hepatitis C virus infection
- Pregnant or nursing women
- Use of glucocorticoids for systemic therapy within one week prior to trial entry
- Previous treatment with any gene therapy products
- Bone marrow AML burden (MRD) above 50%
- Patients judged by investigators as unable to comply with the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen Geno-Immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Lung-Ji Chang, Ph.D
CONTACT
Y
Ying Deng
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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