Actively Recruiting
Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Led by Essen Biotech · Updated on 2024-11-12
85
Participants Needed
1
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.
CONDITIONS
Official Title
Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with acute myeloid leukemia and voluntarily signed informed consent
- Age older than 6 months
- Confirmed expression of CLL-1, CD123, and/or CD33 on AML blast cells
- Karnofsky performance status score higher than 80 and life expectancy greater than 3 months
- Adequate bone marrow, liver, and kidney function as shown by lab tests
- Cardiac ejection fraction of 50% or higher
- Oxygen saturation of 90% or higher
- Creatinine no more than 2.5 times the upper limit of normal
- AST and ALT no more than 3 times the upper limit of normal
- Total bilirubin no more than 2.0 mg/dL
- Hemoglobin level of 80 g/L or higher
- No contraindications for cell separation
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Severe illness or medical condition preventing study management, including uncontrolled infection
- Active bacterial, fungal, or viral infection not controlled by treatment
- Known infection with HIV, hepatitis B virus, or hepatitis C virus
- Pregnant or nursing women
- Use of systemic glucocorticoids within one week before joining the trial
- 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
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
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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