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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03275493
Other study ID # UnicarTherapy201701
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2017
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Contact Xiaowen Tang, PhD
Phone 8651267781525
Email tangxiaowen@suda.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 CD19+ acute lymphoblastic leukemia patients.


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 with CRS suppression technology.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 65 Years
Eligibility Inclusion Criteria: 1. Age 6 to 65 2. Voluntary informed consent is given 3. Expected survival =12 weeks 4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT 5. 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% 6. Karnofsky score = 60 ; 7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months; Exclusion Criteria: 1. Uncontrolled active infections 2. Active hepatitis B or hepatitis C infection 3. HIV infection 4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia 5. Congenital immunodeficiency 6. Pregnant or lactating women 7. 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 8. Previous treatment with any gene therapy products

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD19 CAR-T cells
Express a Second Generation 4-1BB: CD19 CAR-T cells
CD19 CAR-T cells with CRS suppression technology
Express a Second Generation 4-1BB:CD19 CAR-T cells with CRS suppression technology

Locations

Country Name City State
China The first affiliated hospital of soochow university Suzhou Jiangsu

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of severe CRS The safety of the CD19 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined 30 days after infusion of CD19 CAR-T cells
Secondary Overall response of CD19 CAR-T cells treatment who achieve morphology complete remission(CR) and MRD negativity. The efficacy of the CD19 CAR-T cells infusion will be estimated based on the number of participants who have morphology complete remission(CR) and MRD negativity following the CD19 CAR- T cells infusion 30 days after infusion of CD19 CAR-T cells
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