Actively Recruiting
A Multicenter Study of CD19 CAR-T Cells in the Treatment of Adult Patients With Primary Ph Chromosome Positive Acute Lymphoblastic Leukemia
Led by Zhejiang University · Updated on 2025-12-04
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the use of CD19 CAR-T cell therapy in adult patients newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This open-label, multicenter study aims to assess how effective and safe this treatment is for this specific group of leukemia patients. Additional goals include studying how the CAR-T cells grow and persist in the body, as well as their effect on B-cell levels. Participants will receive an intravenous infusion of CD19 CAR-T cells at a dose of 2 x 10^6 CAR+ T cells per kilogram of body weight. The study includes approximately 50 adult patients and is designed as a single-arm trial without a comparison group. The treatment is administered once, followed by monitoring and evaluation periods. During the study, patients will be closely monitored for treatment response and safety. Key assessments include measuring the complete molecular response rate 28 days after infusion and tracking outcomes such as leukemia-free survival, overall survival, and relapse incidence over two years. Patients will undergo blood tests, genetic testing, heart function evaluations, and be observed for any infections or other health changes. Participation involves signing informed consent and agreeing to contraception measures if of childbearing potential.
CONDITIONS
Brief 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
- Diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) according to 2016 WHO Classification
- Abnormal B cells positive for CD19 and CD22 by immunophenotyping
- Positive for Philadelphia chromosome and BCR/ABL1 fusion gene by genetic testing
- Newly diagnosed B-ALL patients without prior chemotherapy treatment
- Serum total bilirubin 51 bcmol/L or less
- Serum ALT and AST no more than 3 times the upper normal limit
- Serum creatinine 176.8 bcmol/L or less
- Left ventricular ejection fraction (LVEF) 50% or higher
- No active lung infection and oxygen saturation 92% or higher without oxygen
- Estimated survival time of 3 months or more
- ECOG performance status score between 0 and 2
- Agree to use contraception before enrollment, during study, and up to 6 months after infusion if of childbearing potential
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of epilepsy or other central nervous system diseases
- Prior history of QT interval prolongation or severe heart diseases
- Pregnant or breastfeeding women
- Untreated active infections
- Chronic hepatitis B or hepatitis C infection without completed treatment or detectable viral load
- HIV antibody positive
- Syphilis antibody positive
- Previous receipt of any gene therapy products
- Other uncontrolled diseases making participation unsuitable
- Any condition deemed by investigator to increase risk or interfere with study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days after infusion
Participants receive CD19 CAR-T cell therapy through intravenous infusion.
1 baseline visit and several visits during the first 28 days after infusion
Duration - 2 years after infusion
Participants are monitored for leukemia-free survival, overall survival, and relapse rates over 2 years after infusion.
Regular follow-up visits over 2 years
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
Y
Yongxian Hu
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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