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

Phase 1

• Conditions: B Cell Lymphoma
• Interventions: Drug: Fludarabine; Drug: Cyclophosphamide; Biological: CD19 CART

• Registration Number: NCT03146533
• Lead Sponsor: Shenzhen Second People's Hospital

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.

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-05
• Study First Submitted: 2017-05-07
• Study First Submitted QC: 2017-05-07
• Study First Posted: 2017-05-10
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17
• Primary Completion: 2019-04
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Read More

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;

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CART	Cyclophosphamide	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.
CD19 CART	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.
CD19 CART	Fludarabine	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.

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	2 years
overall survival	2 years	OS
observe the maximum tolerated dose (MTD)	2 months
objective response rate	2 years	CR+PR
disease control rate	2 years	CR+PR+SD
safety as assessed by the occurence of study related adverse events	6 months	monitor the occurence of study related adverse events

Secondary Outcome Measures

Name	Time	Method
Peripheral blood cytokines	2 months	IL-6、IL-10、IFN-γ、TNF-α
subgroup of T cell	2 years	CD3、CD4、CD8
Determine duration of in vivo survival of CD19 CART cells	2 years	CD19 CART vector sequences will be performed by Q-PCR

Trial Locations

Locations (1)

The Second People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China