Actively Recruiting
A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
Led by Zhejiang University · Updated on 2020-10-26
120
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 Murine CD19 CAR-T Cells Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies.
CONDITIONS
Official Title
A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CD19+ B-ALL or B-NHL according to specific guidelines
- Relapsed or refractory disease with defined clinical criteria for B-ALL or B-NHL
- Bone marrow lymphoblasts > 5% by morphology or > 1% by flow cytometry for B-ALL
- Philadelphia-chromosome-negative or Ph+ patients intolerant or nonresponsive to TKI treatments for B-ALL
- At least one assessable tumor lesion for B-NHL
- Total bilirubin ≤ 51 umol/L; ALT and AST ≤ 3 times upper limit of normal; creatinine ≤ 176.8 umol/L
- Left ventricular ejection fraction ≥ 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
- Patients or legal guardians provide informed consent
You will not qualify if you...
- History of significant brain trauma, seizures, cerebrovascular disease or related disorders
- Prolonged QT interval or severe heart diseases including severe arrhythmia
- Pregnancy or lactation
- Severe active infections excluding simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C virus infection
- Systemic steroid therapy within 2 weeks prior to screening (except inhaled steroids)
- Previous treatment with any CAR-T cell 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 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，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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