Actively Recruiting
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Led by Zhejiang University · Updated on 2020-08-31
72
Participants Needed
1
Research Sites
313 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 Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma.
CONDITIONS
Official Title
A Study of Humanized CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell ALL and B-cell NHL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 3 to 70 years for B-ALL or aged 18 to 75 years for B-NHL
- Histologically confirmed CD19-positive B-ALL or specific B-NHL types as per clinical guidelines
- Relapsed or refractory disease meeting defined clinical relapse or treatment resistance criteria
- Bone marrow primordial cells >5% by morphology and/or >1% by flow cytometry for B-ALL
- Philadelphia-chromosome negative or intolerant/nonresponsive to TKI treatments for B-ALL
- At least one assessable tumor lesion for B-NHL
- Liver and kidney function within specified normal limits
- Left ventricular ejection fraction (LVEF) ≥ 50% on 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
- Voluntary informed consent signed by patients or legal guardians
You will not qualify if you...
- History of brain trauma, seizures, strokes, or related neurological conditions
- Prolonged QT interval or severe heart diseases including severe arrhythmia
- Pregnant or lactating women
- Severe active infections excluding simple urinary tract infection and bacterial pharyngitis
- Active hepatitis B or C infection
- Systemic steroid therapy within 2 weeks prior to screening (except inhaled steroids)
- Previous treatment with any CAR-T or genetically-modified T cell therapies
- Creatinine > 2.5 mg/dl, ALT/AST > 3 times normal, or bilirubin > 2.0 mg/dl
- Other uncontrolled diseases unsuitable for participation
- HIV infection
- Any condition deemed by investigators to increase risk or interfere with study results
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，College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, PhD
CONTACT
Y
Yongxian Hu, PhD
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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