Actively Recruiting
Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia
Led by Zhejiang University · Updated on 2025-08-27
50
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Clinical Study on the Safety and Effectiveness of Donor Derived CD117 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
CONDITIONS
Official Title
Donor Derived CD117 CAR-T Cells in the Treatment of R/R Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed CD117-positive Acute Myeloid Leukemia (AML) by histology or immunophenotyping
- AML diagnosis meeting 2016 WHO criteria and definitions of relapsed or refractory disease per Chinese guidelines
- Relapsed AML defined by reappearance of leukemic blasts in blood or bone marrow >5% or extramedullary disease after complete remission
- Refractory AML defined by failure to achieve complete remission after two induction cycles, relapse within 12 months after consolidation, relapse beyond 12 months not responding to salvage chemotherapy, two or more relapses, or persistent extramedullary leukemia
- Presence of >5% bone marrow blasts by morphology or >1% by flow cytometry
- Total bilirubin ≤1.5 × upper limit of normal (ULN), ALT and AST ≤3 × ULN, serum creatinine ≤1.5 × ULN
- Left ventricular ejection fraction ≥50% by echocardiography
- Oxygen saturation ≥92% on room air
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Agreement to use highly effective contraception for patients of childbearing potential during the study and for 6 months after infusion
- Voluntary participation with informed consent provided by patient or legal representative
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Prolonged QT interval or severe heart disease
- Active, uncured infection
- Active hepatitis B or C virus infection
- Prior use of any gene therapy products
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Other uncontrolled diseases deemed unsuitable by researchers
- Infection with AIDS virus
- Any other conditions that increase risk or interfere with trial results as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, 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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