Actively Recruiting
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
Led by Zhejiang University · Updated on 2024-05-14
20
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
Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.
CONDITIONS
Official Title
CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- No gender restriction, age over 18 years
- Diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests or diagnosed with B-cell non-Hodgkin lymphoma including diffuse large B-cell lymphoma, follicular lymphoma, or mantle cell lymphoma
- Relapsed or refractory CD19+ B-ALL meeting one of: no complete remission after chemotherapy, remission duration under 12 months, ineffective after remedial treatments, or two or more relapses
- Bone marrow primordial cells above 5% by morphology or above 1% by flow cytometry
- Philadelphia-chromosome-negative patients or Philadelphia-chromosome-positive patients intolerant or unresponsive to two TKI treatments
- Relapsed or refractory B-NHL with no response or relapse after second-line or higher chemotherapy, primary drug resistance, or relapse after autologous stem cell transplant
- At least one measurable tumor lesion as per Lugano 2014 criteria
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times upper normal limit, creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram
- No active lung infection, blood oxygen saturation ≥ 92% on room air
- Estimated survival time of at least 3 months
- ECOG performance status between 0 and 2
- Patient or legal guardian voluntarily consents to participate
You will not qualify if you...
- History of brain injury, unconsciousness, epilepsy, or cerebrovascular diseases
- Prolonged QT interval or severe heart diseases including severe arrhythmia
- Pregnant or lactating women, or patients unwilling to use effective contraception during the study and for 6 months after last infusion
- HIV infection
- Active hepatitis B or C infection
- Cell proliferation rate less than 5 times response to CD3/CD28 co-stimulation
- Other uncontrolled diseases unsuitable for the trial
- Received CAR-T, CAR-NK, or other gene-modified cell therapy within last 6 months
- Any condition increasing risk or interfering with study results as judged by investigator
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, 310000
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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