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CD19-directed CAR T Cells Therapy in Relapsed/Refractory B Cell Malignancy

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537977
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Aibin Liang,MD,Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine

Brief Summary:
Relapsed/refractory leukemia and lymphoma lack effective treatment. The cancer immunotherapy with chimeric antigen receptor (CAR) T cells provides a potent new approach for them. In this clinical trial, the investigators aim to assess the safety and efficacy of administering T cell expressing an anti-CD19 CARs to patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Biological: CD19-directed CAR-T cells Phase 1 Phase 2

Detailed Description:
Tongji Hospital of Tongji University has developed an investigational approach for treating patients with CD19 positive B cell malignancy that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with lentivirus to attack CD19 positive cells, and then giving the cells back to the patients.The main purpose of the study is to assess the safety and efficacy of the treatment with anti-CD19 CAR-T cells in the patients with chemotherapy resistant or refractory CD19 positive B cell malignancy including leukemia and lymphoma.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-directed Chimeric Antigen Receptor T Cells Therapy in Relapsed/Refractory B Cell Malignancy
Actual Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAR-T cells
Autologous 2nd generation CD19-directed CAR-T cells
Biological: CD19-directed CAR-T cells
CD19-directed CAR-T cell infusion will be given by vein




Primary Outcome Measures :
  1. Occurrence of study related adverse events [ Time Frame: 2 years ]
    defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly,likely,or definitely related to the study.


Secondary Outcome Measures :
  1. Response rates to CAR-T cells [ Time Frame: 2 years ]
    Describe the response rates of patients treated with CAR-T cells, including complete remission, partial remission,stable disease and progression disease

  2. Progression free survival(PFS) [ Time Frame: 2 years ]
  3. Duration of remission(DOR) [ Time Frame: 2 years ]
  4. Overall survival(OS) of patients treated with CAR-T cells [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with CD19+ leukemia or lymphoma, meeting the following criteria:

    • At least 2 prior combination chemotherapy regimens (not including single agent monoclonal antibody (Rituximab) therapy)
    • Less than 1 year between last chemotherapy and progression
    • Not eligible or appropriate for allo-HSCT
  • To be aged 6 to 85 years
  • Estimated survival of ≥ 6 months, but ≤ 2 years
  • ECOG score ≤2
  • Relapse after auto-HSCT
  • Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and until follow-up for the last time
  • Voluntary participation in the clinical trials and sign the informed consent

Exclusion Criteria:

  • History of epilepsy or other CNS disease
  • Patients have GVHD, which needs treatment with immunosuppressive agents
  • Patients with prolonged QT interval or severe heart disease
  • Patients in pregnancy or breast-feeding period
  • Uncontrolled active infection
  • Active hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary
  • Previously treatment with any gene therapy products
  • Feasibility assessment during screening demonstrates <20% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation
  • ALT /AST>3 x normal value; Creatinine> 2.5 mg/dl; Bilirubin >2.0 mg/dl
  • Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
  • HIV infection
  • Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation

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): NCT02537977


Contacts
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Contact: Aibin Liang, MD,Ph.D. 0086-021-66111019 lab7182@tongji.edu.cn
Contact: Ping Li, MD,Ph.D. 0086-021-66111015 lilyforever76@126.com

Locations
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China
Shanghai Tongji Hospital, Tongji University School of Medicine Recruiting
Shanghai, China, 200065
Contact: Aibin Liang, MD,Ph.D.    0086-021-66111019    lab7182@tongji.edu.cn   
Sponsors and Collaborators
Shanghai Tongji Hospital, Tongji University School of Medicine
Investigators
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Principal Investigator: Aibin Liang, MD,Ph.D. Shanghai Tongji Hospital, Tongji University School of Medicine
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Responsible Party: Aibin Liang,MD,Ph.D., Director,Department of Hematology, Shanghai Tongji Hospital, Tongji University School of Medicine
ClinicalTrials.gov Identifier: NCT02537977    
Other Study ID Numbers: TJ1537
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Neoplasms