Last updated: February 8, 2023
Sponsor: Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Overall Status: Active - Recruiting
Phase
1/2
Condition
Leukemia
Treatment
N/AClinical Study ID
NCT05381662
UCT19-T19 v1.1
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 18 to 65
- Voluntary informed consent is given
- Expected survival ≥12 weeks
- Relieve CD19+ acute leukemia
- 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 timesof ULN (5)Arterial oxygen saturation> 92%
- Karnofsky score ≥ 60 ;
- No history of combined chemotherapy in the recent 1 month and no immunotherapy in therecent 3 months;
Exclusion
Exclusion Criteria:
- 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, generalizedseizure 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
Study Design
Total Participants: 10
Study Start date:
August 02, 2018
Estimated Completion Date:
December 01, 2025
Study Description
Connect with a study center
The first affiliated hospital of soochow university
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou,
ChinaActive - Recruiting
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