CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.

NCT ID: NCT03146533

Last Updated: 2017-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-31
• Study Completion Date: 2019-10-31

Brief Summary

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

Detailed Description

This is a study for the patients with B cell lymphoma. Maximum tolerated dose climbing test is expected into the group of 9 cases of patients. And Phase II expected into the group of 11 subjects, selected the above safe dose, carrying out a research into the clinical effectiveness. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB:CD28: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 observe the MTD and to assess the safety and feasibility of CART 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

CD19 CART

patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CD19 CART cells. The CD19 CART cells are to be administered on day0,day1,day2.

Group Type: EXPERIMENTAL

Fludarabine

Intervention Type: DRUG

Fludarabine 30 mg/m2/day IV for 3 days.

Cyclophosphamide

Intervention Type: DRUG

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.

CD19 CART

Intervention Type: BIOLOGICAL

CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.

Interventions

Fludarabine

Fludarabine 30 mg/m2/day IV for 3 days.

Intervention Type: DRUG

Cyclophosphamide

patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.

Intervention Type: DRUG

CD19 CART

CD19 CART 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

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

geng tian

Role: PRINCIPAL_INVESTIGATOR

Shenzhen Second People's Hospital

Locations

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

geng tian

Role: CONTACT

tiangeng666@aliyun.com

13724395569

Facility Contacts

geng tian

Role: primary

tiangeng666@aliyun.com

13724395569

Other Identifiers

FirstShenzhen01

Identifier Type: -

Identifier Source: org_study_id