Actively Recruiting
Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia
Led by Zhejiang University · Updated on 2025-01-27
15
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 CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia
CONDITIONS
Official Title
Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- CD19 positive abnormal B cell immunotyping
- Diagnosed with B-cell acute lymphoblastic leukemia by histology or immunotyping
- Relapsed or refractory B-cell acute lymphoblastic leukemia, including no complete remission after standard chemotherapy, remission less than 12 months, failure after remedial treatments, or two or more relapses
- Inadequate response or failure to prepare autologous CAR-T cells
- Total bilirubin ≤ 51 μmol/L; ALT/AST ≤ 3 times upper limit of normal; creatinine ≤ 176.8 μmol/L
- Absolute neutrophil count ≥ 0.5×10⁹/L; Platelet count ≥ 30×10⁹/L; Hemoglobin ≥ 60 g/L
- Left ventricular ejection fraction (LVEF) ≥ 40% by echocardiography
- Estimated survival more than 3 months
- ECOG performance status score between 0 and 2
- Fertile women and men must agree to use contraception during and for 6 months after the study
- Ability to understand and sign informed consent
You will not qualify if you...
- Known allergies to preconditioning treatments
- History of epilepsy or other central nervous system disorders
- History of prolonged QT interval or severe heart disease
- Less than 100 days since allogeneic hematopoietic stem cell transplantation
- HIV infection
- Active hepatitis B or C infection that is not cured
- Insufficient T cell amplification in response to CD3/CD28 stimulation
- Use of systemic steroids (e.g., prednisone ≥ 20 mg) within 3 days prior to screening, except ongoing or intermittent topical, inhaled, or intranasal steroids
- Systemic diseases requiring long-term immunosuppressive agents
- Anti-cancer chemotherapy or other drugs received within 2 weeks prior to screening
- Any condition increasing risk or interfering with study results as judged by investigator
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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