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

Shenzhen University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: B Cell Lymphoma

Treatments: Drug: Cyclophosphamide; Biological: CD19 CART; Drug: Fludarabine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03146533

FirstShenzhen01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

CD19 CART

Experimental group

Description:

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.

Treatment:

Drug: Fludarabine

Drug: Cyclophosphamide

Biological: CD19 CART