Back to resultsCD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
Primary Purpose
B Cell Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fludarabine
Cyclophosphamide
CD19 CART
Sponsored by
About this trial
This is an interventional treatment trial for 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;
Sites / Locations
- The Second People's Hospital of ShenzhenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19 CART
Arm 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.
Outcomes
Primary Outcome Measures
safety as assessed by the occurence of study related adverse events
monitor the occurence of study related adverse events
observe the maximum tolerated dose (MTD)
objective response rate
CR+PR
disease control rate
CR+PR+SD
overall survival
OS
Progression-Free Survival
Secondary Outcome Measures
Determine duration of in vivo survival of CD19 CART cells
CD19 CART vector sequences will be performed by Q-PCR
Peripheral blood cytokines
IL-6、IL-10、IFN-γ、TNF-α
subgroup of T cell
CD3、CD4、CD8
Full Information
NCT ID
NCT03146533
First Posted
May 7, 2017
Last Updated
May 16, 2017
Sponsor
Shenzhen Second People's Hospital
Collaborators
The Beijing Pregene Science and Technology Company, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03146533
Brief Title
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
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2017 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital
Collaborators
The Beijing Pregene Science and Technology Company, Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19 CART
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Fludarabine 30 mg/m2/day IV for 3 days.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.
Intervention Type
Biological
Intervention Name(s)
CD19 CART
Intervention Description
CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Primary Outcome Measure Information:
Title
safety as assessed by the occurence of study related adverse events
Description
monitor the occurence of study related adverse events
Time Frame
6 months
Title
observe the maximum tolerated dose (MTD)
Time Frame
2 months
Title
objective response rate
Description
CR+PR
Time Frame
2 years
Title
disease control rate
Description
CR+PR+SD
Time Frame
2 years
Title
overall survival
Description
OS
Time Frame
2 years
Title
Progression-Free Survival
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Determine duration of in vivo survival of CD19 CART cells
Description
CD19 CART vector sequences will be performed by Q-PCR
Time Frame
2 years
Title
Peripheral blood cytokines
Description
IL-6、IL-10、IFN-γ、TNF-α
Time Frame
2 months
Title
subgroup of T cell
Description
CD3、CD4、CD8
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
geng tian
Phone
13724395569
Email
tiangeng666@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
geng tian
Organizational Affiliation
Shenzhen Second People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
geng tian
Phone
13724395569
Email
tiangeng666@aliyun.com
First Name & Middle Initial & Last Name & Degree
geng tian
12. IPD Sharing Statement
Learn more about this trial
CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
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