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

B Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02968472
• Other study ID #: LXUN
• Status: Recruiting
• Phase: Phase 1
• First received: November 16, 2016
• Last updated: November 17, 2016
• Start date: March 2015
• Est. completion date: May 2019

Study information

• Verified date: November 2016
• Source: The First People's Hospital of Yunnan
• Contact: Lai Xun, Doctor
• Phone: 13577096609
• Email: 1729112214[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• B Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, B-Cell
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Genetic:
• prophylactic 4SCAR19 cells
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19

Locations

Country	Name	City	State
China	First people's hospital of Yunnan province	Kunming	Yunnan

Sponsors (2)

Lead Sponsor	Collaborator
The First People's Hospital of Yunnan	Shenzhen Geno-Immune Medical Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.	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.	24 weeks	Yes
Secondary	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	No