Clinical trial NCT02968472: A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
Official title: Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: B Acute Lymphoblastic Leukemia
Keywords: 4s CAR-T19
B cell leukemia
B-ALL
Lead sponsor: The First People's Hospital of Yunnan
Sponsor class: OTHER
Collaborators: name: Shenzhen Geno-Immune Medical Institute
First posted: 2016-11-18
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
timeFrame: 24 weeks
Secondary outcomes:
measure: Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)
timeFrame: 1 year
Other outcomes:
Locations:
city: Kunming
country: China
facility: First people's hospital of Yunnan province
state: Yunnan
Study officials:
affiliation: Shenzhen immune gene therapy research institute
name: Huang Jianzhang, Doctor
role: STUDY_CHAIR
References:
citation: Lai X, Sun YY, Chang LJ, Ma YR, Gu XZ, Yao XM, Nie B, Wen Y, Zhang XM, Jiang YX, Yang H, Yu LQ, Fang MJ, Wang L, Yuan Bo X. Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy? Bioengineered. 2020 Dec;11(1):824-828. doi: 10.1080/21655979.2020.1791597.