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The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03101709
Recruitment Status : Unknown
Verified March 2017 by Henan Cancer Hospital.
Recruitment status was:  Recruiting
First Posted : April 5, 2017
Last Update Posted : April 5, 2017
The Beijing Pregene Science and Technology Company, Ltd.
Information provided by (Responsible Party):
Henan Cancer Hospital

Brief Summary:
This is a clinical study to observe the safety and feasibility of chimeric antigen receptor 19 (CART-19) cells in relapsed and refractory patients with CD19+ B cell lymphoma.

Condition or disease Intervention/treatment Phase
B Cell Lymphoma Drug: Cyclophosphamide Drug: Fludarabine Biological: CART-19 Phase 1

Detailed Description:

This is a study for the patients with B cell lymphoma. Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase. Subjects will be collected their T cells and modify them, the modification is a genetic change, that CD19:4-1BB: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 to assess ssess the safety and feasibility of CART-19 cells in the patients with relapsed and refractory CD19+ B cell lymphoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of CART-19 Cells in Relapse and Refractory Patients With CD19+ B-cell Lymphoma
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Safety

Arm Intervention/treatment
Experimental: CART-19
patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
Drug: Cyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).

Drug: Fludarabine
Fludarabine 25 mg/m2/day IV for 3 days (Day-5 to day-3).

Biological: CART-19
CART-19 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

Secondary Outcome Measures :
  1. efficacy assessed by anti-tumor activity of CART-19 cells [ Time Frame: 2 years ]
    anti-tumor activity of CART-19 cells will be determined in a follow-on study

  2. duration of CART-19 [ Time Frame: 2 years ]
    Determine duration of in vivo survival of CART-19 cells

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

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): NCT03101709

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Contact: Yongping Song ph200811@163.com

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China, Henan
Henan Cancer Hospital Recruiting
Zhengzhou, Henan, China
Contact: Yongping Song    -86-13521186987    ph200811@163.com   
Contact: Yongping Song         
Principal Investigator: Yongping Song, MD         
Sponsors and Collaborators
Henan Cancer Hospital
The Beijing Pregene Science and Technology Company, Ltd.
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Study Director: Yongping Song Henan Cancer Hospital
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Responsible Party: Henan Cancer Hospital
ClinicalTrials.gov Identifier: NCT03101709    
Other Study ID Numbers: HenanCH109
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: March 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, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists