B Acute Lymphoblastic Leukemia
Conditions
Keywords
4s CAR-T19, B cell leukemia, B-ALL
Brief summary
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.
Interventions
GENETICprophylactic 4SCAR19 cells
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Sponsors
Shenzhen Geno-Immune Medical Institute
The First People's Hospital of Yunnan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* patients aged more than 6 months. * the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules. * the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months. * the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less. * or greater Hgb 80 g/L. * no contraindications to solid and cell separation * the patient and family to have a strong willingness to participate in clinical trials, and are willing to bear all the consequence caused by the test failed, and sign the informed consent. * the panel discussion, combined with patient general condition, think the benefit is greater than the risks involved in the clinical trials.
Exclusion criteria
* accompanied with other active disease, the treatment is difficult to correct. * bacteria, fungus, or virus infection, unable to control. * people living with HIV. * active hepatitis B virus and hepatitis C virus infection. * of pregnancy and nursing mothers. * before entering the test of the use of glucocorticoid systemic treatment within a week. * confirmed before used CAR - but invalid patients treated T cells, after in the physical examination, experts discuss confirmed by a team doesn't fit in the CAR again - T treatment.Before used gene therapy method. * the researchers believe that might increase risk subjects or interfere with the test results of any situation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells. | 24 weeks | Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells. |
Secondary
| Measure | Time frame |
|---|---|
| Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia) | 1 year |
Countries
China
Contacts
Primary ContactLai Xun, Doctor
Backup ContactChang Lung-Ji, Doctor
Outcome results
None listed