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

NCT ID: NCT03101709

Last Updated: 2017-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-07-31

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.

Conditions

B Cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CART-19

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.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: DRUG

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).

Fludarabine

Intervention Type: DRUG

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

CART-19

Intervention Type: BIOLOGICAL

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

Interventions

Cyclophosphamide

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

Fludarabine

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

Intervention Type: DRUG

CART-19

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 18 years to 70 years, expected survival > 3 months;

2. CD19 positive B-cell lymphoma;

3. KPS >80;

4. Having at least one measurable lesions;

5. 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）;

6. No serious allergic constitution;

7. No other serous diseases that conflicts with the clinical program;

8. No other cancer history;

9. No serious mental disorder;

10. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test);

2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;

3. Active hepatitis B or hepatitis C infection;

4. Recent or current use of glucocorticoid or other immunosuppressor;

5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;

6. Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN

7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;

8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Beijing Pregene Science and Technology Company, Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongping Song

Role: STUDY_DIRECTOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongping Song

Role: CONTACT

ph200811@163.com

Facility Contacts

Yongping Song

Role: primary

ph200811@163.com

-86-13521186987

Yongping Song

Role: backup

Other Identifiers

HenanCH109

Identifier Type: -

Identifier Source: org_study_id