CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Launched by SHANGHAI UNICAR-THERAPY BIO-MEDICINE TECHNOLOGY CO.,LTD · Sep 6, 2017
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new treatment for patients with relapsed or refractory CD19+ acute lymphoblastic leukemia, a type of blood cancer. The treatment involves using specially modified T cells, which are a type of immune cell, to target and fight the cancer. The goal is to see how effective and safe this treatment is for patients who have not responded to other therapies. The trial is currently recruiting participants aged 6 to 65 who have been diagnosed with this specific type of leukemia and are in need of new treatment options.
To join the trial, participants must be able to provide informed consent and have a life expectancy of at least 12 weeks. They should not have had any recent major infections or certain medical conditions, such as active hepatitis or HIV, and must meet specific health criteria related to organ function. Participants will receive the experimental treatment and be monitored closely for side effects and effectiveness. This trial is important because it may offer new hope for patients who have run out of other treatment options.
Gender
ALL
Eligibility criteria
- 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
About Shanghai Unicar Therapy Bio Medicine Technology Co.,Ltd
Shanghai Unicar-Therapy Bio-Medicine Technology Co., Ltd. is a leading biotechnology firm focused on innovative therapeutic solutions in the field of regenerative medicine. With a commitment to advancing healthcare through cutting-edge research and development, the company specializes in novel cell-based therapies and biopharmaceuticals. Leveraging a robust pipeline of clinical trials, Shanghai Unicar-Therapy aims to address unmet medical needs and improve patient outcomes across various diseases. The organization is dedicated to maintaining high standards of scientific integrity and regulatory compliance, positioning itself as a key player in the global biomedicine landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Suzhou, Jiangsu, China
Patients applied
Trial Officials
Xiaowen Tang, PhD
Principal Investigator
The First Affiliated Hospital of Soochow University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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