Clinical trial NCT03146533: CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
Official title: Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: B Cell Lymphoma
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
Collaborators: name: The Beijing Pregene Science and Technology Company, Ltd.
First posted: 2017-05-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: safety as assessed by the occurence of study related adverse events
timeFrame: 6 months
measure: observe the maximum tolerated dose (MTD)
timeFrame: 2 months
measure: objective response rate
timeFrame: 2 years
measure: disease control rate
timeFrame: 2 years
measure: overall survival
timeFrame: 2 years
measure: Progression-Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Determine duration of in vivo survival of CD19 CART cells
timeFrame: 2 years
measure: Peripheral blood cytokines
timeFrame: 2 months
measure: subgroup of T cell
timeFrame: 2 years
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: geng tian
role: PRINCIPAL_INVESTIGATOR
References: