Actively Recruiting
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
Led by Zhejiang University · Updated on 2025-01-07
27
Participants Needed
1
Research Sites
146 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 targeting CD33 CAR-T Cell in the treatment of Relapsed/Refractory Acute Myeloid Leukemia
CONDITIONS
Official Title
A Clinical Study to Explore the Safety and Efficacy of CD33 CAR-T Cell in Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, age 18 years or older
- Able to prepare CAR-T cells normally or have failed autologous CAR-T cell preparation
- Diagnosed with CD33 positive acute myeloid leukemia with CD33 expression rate above 80%
- Meet the 2016 WHO classification for AML and criteria for relapsed or refractory AML according to Chinese guidelines
- Bone marrow primitive cells (promyelocytes and/or myelocytes) greater than 5% morphologically or greater than 1% by flow cytometry
- Total bilirubin less than or equal to 51 micromol/L, ALT and AST less than or equal to 3 times the upper normal limit, serum creatinine less than or equal to 176.8 micromol/L
- Left ventricular ejection fraction (LVEF) at least 50% by echocardiography
- No active lung infection with oxygen saturation above 92% on room air
- Estimated survival time more than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- Pregnant or lactating women, or patients with fertility willing to use effective contraception for at least 6 months after last infusion
- Voluntarily agree to participate and provide informed consent
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Prolonged QT interval or severe heart disease
- Untreated active infection
- Active hepatitis B or C infection
- Previous use of gene therapy products
- Proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Other uncontrolled diseases deemed unsuitable by researchers
- HIV infection
- Any condition increasing risk or interfering with study results as judged by researchers
AI-Screening
AI-Powered Screening
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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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