Status:
UNKNOWN
CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Lead Sponsor:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Lymphoblastic Leukemia
CD19 Positive
Eligibility:
All Genders
6-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory...
Detailed Description
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells w...
Eligibility Criteria
Inclusion
- Age 6 to 65
- Voluntary informed consent is given
- Expected survival ≥12 weeks
- Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT
- Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation\> 92%
- Karnofsky score ≥ 60 ;
- No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months;
Exclusion
- Uncontrolled active infections
- Active hepatitis B or hepatitis C infection
- HIV infection
- History of myocardio infarction in the past 6 months, or history of severe arrhythmia
- Congenital immunodeficiency
- Pregnant or lactating women
- History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Previous treatment with any gene therapy products
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03275493
Start Date
July 1 2017
End Date
December 31 2025
Last Update
May 28 2024
Active Locations (1)
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1
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China, 200000