Actively Recruiting
A Multicenter Study of CAR-T Cells in Primary Ph+All
Led by Zhejiang University · Updated on 2025-12-04
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 Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
CONDITIONS
Official Title
A Multicenter Study of CAR-T Cells in Primary Ph+All
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Diagnosed with B-cell acute lymphoblastic leukemia according to the 2016 WHO Classification
- Presence of abnormal B cells positive for CD19 and CD22 markers
- Positive for Philadelphia chromosome and BCR/ABL1 fusion gene by chromosomal and genetic testing
- Newly diagnosed patients who have not received standard chemotherapy
- Serum total bilirubin 51 bcmol/L or less
- Serum ALT and AST levels 3 times or less the upper limit of normal
- Serum creatinine 176.8 bcmol/L or less
- Left ventricular ejection fraction 50% or higher
- No active lung infection and oxygen saturation 92% or higher without oxygen support
- Estimated survival time of 3 months or longer
- ECOG performance status score between 0 and 2
- Agreement to use effective contraception before, during, and for 6 months after treatment
- Voluntary participation with signed informed consent form
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- History of QT interval prolongation or severe heart diseases
- Pregnant or breastfeeding women
- Untreated active infections
- Chronic hepatitis B infection without proper antiviral treatment or with detectable viral load
- Untreated or detectable hepatitis C infection
- HIV antibody positive
- Syphilis antibody positive
- Previous treatment with any gene therapy products
- Other uncontrolled diseases judged unsuitable by investigators
- Any condition that may increase risk or interfere with study results as judged by investigators
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
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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