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

Primary Purpose

B Acute Lymphoblastic Leukemia

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

prophylactic 4SCAR19 cells

About this trial

This is an interventional treatment trial for B Acute Lymphoblastic Leukemia focused on measuring 4s CAR-T19, B cell leukemia, B-ALL

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

First people's hospital of Yunnan provinceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

prophylactic 4SCAR19 cells

Arm Description

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

Outcomes

Primary Outcome Measures

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.

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)

Full Information

NCT ID

NCT02968472

First Posted

November 16, 2016

Last Updated

November 17, 2016

Sponsor

The First People's Hospital of Yunnan

Collaborators

Shenzhen Geno-Immune Medical Institute

1. Study Identification

Unique Protocol Identification Number

NCT02968472

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2015 (undefined)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The First People's Hospital of Yunnan

Collaborators

Shenzhen Geno-Immune Medical Institute

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B Acute Lymphoblastic Leukemia

Keywords

4s CAR-T19, B cell leukemia, B-ALL

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

prophylactic 4SCAR19 cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Genetic

Intervention Name(s)

prophylactic 4SCAR19 cells

Intervention Description

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

Primary Outcome Measure Information:

Title

Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.

Description

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.

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lai Xun, Doctor

Phone

13577096609

1729112214@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chang Lung-Ji, Doctor

Phone

13671121909

longflorida@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huang Jianzhang, Doctor

Organizational Affiliation

Shenzhen immune gene therapy research institute

Official's Role

Study Chair

Facility Information:

Facility Name

First people's hospital of Yunnan province

City

Kunming

State/Province

Yunnan

ZIP/Postal Code

NCT650000

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

32772769

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.

Results Reference

derived

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

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