Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | The first affiliated hospital of soochow university | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd | The First Affiliated Hospital of Soochow University |
China,
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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