Trial | NCT03101709  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    cd19 car-t cells ...

  • Study Participants

    30
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.
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.
Study Started
Aug 31
2016
Primary Completion
Jul 31
2018
Anticipated
Study Completion
Jul 31
2019
Anticipated
Last Update
Apr 05
2017

Drug 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).

Drug Fludarabine

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

Biological 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.

CART-19 Experimental

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.

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;
No Results Posted