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

B Cell Lymphoma Clinical Trial

Official title:

Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146533
• Other study ID #: FirstShenzhen01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 7, 2017
• Last updated: May 16, 2017
• Start date: May 2017
• Est. completion date: October 2019

Study information

• Verified date: April 2017
• Source: Shenzhen Second People's Hospital
• Contact: geng tian
• Phone: 13724395569
• Email: tiangeng666[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell

Intervention

Drug:
• Fludarabine
Fludarabine 30 mg/m2/day IV for 3 days.
• Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.

Biological:
• 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.

Locations

Country	Name	City	State
China	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital	The Beijing Pregene Science and Technology Company, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety as assessed by the occurence of study related adverse events	monitor the occurence of study related adverse events	6 months
Primary	observe the maximum tolerated dose (MTD)		2 months
Primary	objective response rate	CR+PR	2 years
Primary	disease control rate	CR+PR+SD	2 years
Primary	overall survival	OS	2 years
Primary	Progression-Free Survival		2 years
Secondary	Determine duration of in vivo survival of CD19 CART cells	CD19 CART vector sequences will be performed by Q-PCR	2 years
Secondary	Peripheral blood cytokines	IL-6?IL-10?IFN-??TNF-a	2 months
Secondary	subgroup of T cell	CD3?CD4?CD8	2 years