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

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03146533
Collaborator
The Beijing Pregene Science and Technology Company, Ltd. (Industry)
20
Enrollment
1
Location
1
Arm
29
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I/II Study of CD19 CART Cells for Patients With Relapse and Refractory CD19+ B-cell Lymphoma.
Anticipated Study Start Date :
May 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Fludarabine
Fludarabine 30 mg/m2/day IV for 3 days.

Drug: 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.

Outcome Measures

Primary Outcome Measures

  1. safety as assessed by the occurence of study related adverse events [6 months]

    monitor the occurence of study related adverse events

  2. observe the maximum tolerated dose (MTD) [2 months]

  3. objective response rate [2 years]

    CR+PR

  4. disease control rate [2 years]

    CR+PR+SD

  5. overall survival [2 years]

    OS

  6. Progression-Free Survival [2 years]

Secondary Outcome Measures

  1. Determine duration of in vivo survival of CD19 CART cells [2 years]

    CD19 CART vector sequences will be performed by Q-PCR

  2. Peripheral blood cytokines [2 months]

    IL-6、IL-10、IFN-γ、TNF-α

  3. subgroup of T cell [2 years]

    CD3、CD4、CD8

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. 18 years to 70 years, expected survival > 3 months;
    1. CD19 positive B-cell lymphoma;
    1. KPS >80;
    1. Having at least one measurable lesions;
    1. 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）;
    1. No serious allergic constitution;
    1. No other serous diseases that conflicts with the clinical program;
    1. No other cancer history;
    1. No serious mental disorder;
    1. 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);
    1. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
    1. Active hepatitis B or hepatitis C infection;
    1. Recent or current use of glucocorticoid or other immunosuppressor;
    1. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;
    1. Transaminase >2.5ULN, Bilirubin >3ULN，Creatinine>1.25ULN
    1. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;
    1. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results;

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second People's Hospital of Shenzhen Shenzhen Guangdong China

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: geng tian, Shenzhen Second People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier:
NCT03146533
Other Study ID Numbers:
  • FirstShenzhen01
First Posted:
May 10, 2017
Last Update Posted:
May 17, 2017
Last Verified:
Apr 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Cyclophosphamide
Fludarabine

Study Results

No Results Posted as of May 17, 2017