Status:
UNKNOWN
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
Lead Sponsor:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborating Sponsors:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
18-65 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 combined with CD19 positive feede...
Detailed Description
Patients were divided into two groups, group 1 and group 2, and each group was enrolled in 5 patients. Group 1 patients did not receive any pretreatment, and group 2 patients received pretreatment wit...
Eligibility Criteria
Inclusion
- 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 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 :
August 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05381662
Start Date
August 2 2018
End Date
December 1 2025
Last Update
February 10 2023
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China, 200000
2
The first affiliated hospital of soochow university
Suzhou, Jiangsu, China, 215006
3
The First Affiliated Hospital of Soochow University
Suzhou, China