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The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

Primary Purpose

B Cell Lymphoma

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Cyclophosphamide

Fludarabine

CART-19

About this trial

This is an interventional treatment trial for B Cell Lymphoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years to 70 years, expected survival > 3 months;
CD19 positive B-cell lymphoma;
KPS >80;
Having at least one measurable lesions;
Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）;
No serious allergic constitution;
No other serous diseases that conflicts with the clinical program;
No other cancer history;
No serious mental disorder;
Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);
Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
Active hepatitis B or hepatitis C infection;
Recent or current use of glucocorticoid or other immunosuppressor;
With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN
Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;

Sites / Locations

Henan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CART-19

Arm Description

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.

Outcomes

Primary Outcome Measures

safety as assessed by the occurence of study related adverse events

monitor the occurence of study related adverse events

Secondary Outcome Measures

efficacy assessed by anti-tumor activity of CART-19 cells

anti-tumor activity of CART-19 cells will be determined in a follow-on study

duration of CART-19

Determine duration of in vivo survival of CART-19 cells

Full Information

NCT ID

NCT03101709

First Posted

March 30, 2017

Last Updated

April 4, 2017

Sponsor

Henan Cancer Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03101709

Brief Title

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

Official Title

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

August 2016 (Actual)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan Cancer Hospital

Collaborators

The Beijing Pregene Science and Technology Company, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

Detailed Description

This is a study for the patients with B cell lymphoma. Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD3 modified T cells, in order to tells the T cells to recognize their target tumor cells and potentially kill them, but not other normal cells in the subject's body. The CART cells will then be expanded in vitro and then administered to subjects. The purpose of this study is to assess ssess the safety and feasibility of CART-19 cells in the patients with relapsed and refractory CD19+ B cell lymphoma.

6. Conditions and Keywords

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

B Cell Lymphoma

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

CART-19

Arm Type

Experimental

Arm Description

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Intervention Description

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

Intervention Type

Drug

Intervention Name(s)

Fludarabine

Intervention Description

Fludarabine 25 mg/m2/day IV for 3 days (Day-5 to day-3).

Intervention Type

Biological

Intervention Name(s)

CART-19

Intervention Description

CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Primary Outcome Measure Information:

Title

safety as assessed by the occurence of study related adverse events

Description

monitor the occurence of study related adverse events

Time Frame

6 months

Secondary Outcome Measure Information:

Title

efficacy assessed by anti-tumor activity of CART-19 cells

Description

anti-tumor activity of CART-19 cells will be determined in a follow-on study

Time Frame

2 years

Title

duration of CART-19

Description

Determine duration of in vivo survival of CART-19 cells

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years to 70 years, expected survival > 3 months; CD19 positive B-cell lymphoma; KPS >80; Having at least one measurable lesions; Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN; bone marrow: WBC ≥ 3.0×109/L, Hb ≥90 g/L, PLT ≥ 80×109/L）; No serious allergic constitution; No other serous diseases that conflicts with the clinical program; No other cancer history; No serious mental disorder; Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test); Uncontrolled active infection, HIV infection, syphilis serology reaction positive; Active hepatitis B or hepatitis C infection; Recent or current use of glucocorticoid or other immunosuppressor; With severe cardiac, liver, renal insufficiency, diabetes and other diseases; Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN Participate in other clinical research in the past three months; previously treatment with any gene therapy products; Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;

Central Contact Person:

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

Yongping Song

ph200811@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongping Song

Organizational Affiliation

Henan Cancer Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Henan Cancer Hospital

City

Zhengzhou

State/Province

Henan

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yongping Song

Phone

-86-13521186987

ph200811@163.com

First Name & Middle Initial & Last Name & Degree

Yongping Song

First Name & Middle Initial & Last Name & Degree

Yongping Song, MD

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

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