Actively Recruiting
A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies
Led by Zhejiang University · Updated on 2020-10-26
72
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies
CONDITIONS
Official Title
A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For B-ALL: Male or female aged 3-70 years
- For B-ALL: Histologically confirmed diagnosis of B-ALL per NCCN guidelines
- For B-ALL: Relapsed or refractory CD19+ B-ALL meeting specific chemotherapy and relapse criteria
- For B-ALL: Bone marrow primordial cells >5% by morphology or >1% by flow cytometry
- For B-ALL: Philadelphia-chromosome-negative or Ph+ patients intolerant or unresponsive to 2 TKI treatments
- For B-NHL: Male or female aged 18-75 years
- For B-NHL: Histologically confirmed diagnosis of specified lymphoma subtypes per WHO criteria
- For B-NHL: Relapsed or refractory B-NHL meeting specified chemotherapy and relapse conditions
- For B-NHL: At least one assessable tumor lesion per Lugano 2014 criteria
- Common: Highly suspected or confirmed CNS involvement of hematological malignancies
- Common: Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times upper limit of normal, creatinine ≤ 176.8 umol/L
- Common: Echocardiogram showing LVEF ≥ 50%
- Common: No active lung infection, blood oxygen saturation ≥ 92% indoors
- Common: Estimated survival time ≥ 3 months
- Common: ECOG performance status 0 to 2
- Common: Patients or legal guardians volunteer and sign informed consent
You will not qualify if you...
- History of brain trauma, consciousness disturbance, epilepsy, cerebrovascular ischemia or hemorrhage
- Electrocardiogram showing prolonged QT interval or severe heart disease including severe arrhythmia
- Pregnant or breastfeeding women
- Severe active infections except simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or hepatitis C infection
- Systemic steroid therapy within 2 weeks prior to screening except recent or current inhaled steroids
- Previous treatment with any CAR-T or genetically-modified T cell therapies
- Creatinine > 2.5 mg/dl, or ALT/AST > 3 times normal, or bilirubin > 2.0 mg/dl
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any condition that may increase patient risk or interfere with study results as judged by the investigator
AI-Screening
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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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