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

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