A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia

Sponsor

The First People's Hospital of Yunnan (Other)

Overall Status

Unknown status

CT.gov ID

NCT02968472

Collaborator

Shenzhen Geno-Immune Medical Institute (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B Acute Lymphoblastic Leukemia	Genetic: prophylactic 4SCAR19 cells	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

May 1, 2019

Anticipated Study Completion Date :

May 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prophylactic 4SCAR19 cells Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.	Genetic: prophylactic 4SCAR19 cells Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19

Arm

Intervention/Treatment

Experimental: prophylactic 4SCAR19 cells

Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.

Genetic: prophylactic 4SCAR19 cells

Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.