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

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ClinicalTrials.gov Identifier: NCT03146533
Recruitment Status : Unknown
Verified April 2017 by Shenzhen Second People's Hospital.
Recruitment status was:  Recruiting
First Posted : May 10, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
The Beijing Pregene Science and Technology Company, Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Drug: Fludarabine Drug: Cyclophosphamide Biological: CD19 CART 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Fludarabine

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.




Primary Outcome Measures :
  1. safety as assessed by the occurence of study related adverse events [ Time Frame: 6 months ]
    monitor the occurence of study related adverse events

  2. observe the maximum tolerated dose (MTD) [ Time Frame: 2 months ]
  3. objective response rate [ Time Frame: 2 years ]
    CR+PR

  4. disease control rate [ Time Frame: 2 years ]
    CR+PR+SD

  5. overall survival [ Time Frame: 2 years ]
    OS

  6. Progression-Free Survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Determine duration of in vivo survival of CD19 CART cells [ Time Frame: 2 years ]
    CD19 CART vector sequences will be performed by Q-PCR

  2. Peripheral blood cytokines [ Time Frame: 2 months ]
    IL-6、IL-10、IFN-γ、TNF-α

  3. subgroup of T cell [ Time Frame: 2 years ]
    CD3、CD4、CD8



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146533


Contacts
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Contact: geng tian 13724395569 tiangeng666@aliyun.com

Locations
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China, Guangdong
The Second People's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China
Contact: geng tian    13724395569    tiangeng666@aliyun.com   
Principal Investigator: geng tian         
Sponsors and Collaborators
Shenzhen Second People's Hospital
The Beijing Pregene Science and Technology Company, Ltd.
Investigators
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Principal Investigator: geng tian Shenzhen Second People's Hospital

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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT03146533     History of Changes
Other Study ID Numbers: FirstShenzhen01
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 17, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites