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Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory 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: NCT03207178
Recruitment Status : Unknown
Verified June 2017 by Shanghai Longyao Biotechnology Inc., Ltd..
Recruitment status was:  Recruiting
First Posted : July 2, 2017
Last Update Posted : July 2, 2017
Sponsor:
Collaborators:
Xuzhou Medical University
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Shanghai Longyao Biotechnology Inc., Ltd.

Study Description
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Brief Summary:
Cluster of differentiation antigen 19(CD19) specifically presents in B lymphocyte cell lines steadily,while not in most normal tissue,including pluripotent hematopoietic stem cells.Cluster of differentiation antigen 20(CD20) presents in 90% of B-cell lymphomas.CD19 antigen is a well-established target for B-cell lymphomas treatment as well as CD20 antigen.Both CD19-targeting CAR T Cells and CD20-targeting CAR T Cells can be used as adoptive cellular immunotherapies for B-cell lymphomas.Though two kinds of single target treatments were proved can induce recession of B-cell lymphomas, the risk of cancer cells to escape and tumor recurrence are still existed. There are no report about combination transfer of two kinds of single target treatments.This research aimed emphasis on safety and therapeutic efficacy evaluation,as well as if combination transfer can decrease recurrence rate.

Condition or disease Intervention/treatment Phase
Recurrent or Refractory B Cell Malignancy Biological: Mixed CD19/CD20 CAR-T Transfer Phase 1 Phase 2

Detailed Description:

To determine:

Primary Outcome Measure:

The Overall complete remission rate and one-year survival rate of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is superior to or at least not worse than two kinds of single target treatments in the treatment of CD19+/CD20+ B-cell lymphomas.

The risk of cancer recurrence in a year of combination transfer of CD19-targeting CAR T Cells and CD20-targeting CAR T Cells is inferior to two kinds of single target treatments.

Secondary Outcome Measures:

Evaluate the initial effect time, time to disease progression, and life quality improvement of combination transfer compare to single target treatments.

Evaluate the safety and tolerability of combination transfer compare to single target treatments by observation of high fever duration in patients and testing related cell factor level in peripheral blood.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 28, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mixed CD19/CD20 CAR-T Transfer
Subjects with CD19+/CD20+ B-cell lymphomas will be infused with CD19-targeting CAR T Cells and CD20-targeting CAR T Cells in one time or in parts
 Biological: Mixed CD19/CD20 CAR-T Transfer
Autologous CD19 CAR-T cells and CD20 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.


Outcome Measures
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Primary Outcome Measures :
  1. Overall complete remission rate [ Time Frame: Half a year ]
    The complete remission rate will be evaluated by routine methods.


Secondary Outcome Measures :
  1. The initial effect time [ Time Frame: 1 year ]
    The initial effect time will be recorded.

  2. The one-year survival rate [ Time Frame: 1 year ]
    The one-year survival rate will be recorded.

  3. The safety and the tolerability(incidence of treatment-emergent adverse events defined as dose-limited toxicity) [ Time Frame: 1 month ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

  4. The time to disease progression [ Time Frame: 1 year ]
    The time to disease progression will be counted after complete remission.

  5. The one-year recurrence [ Time Frame: 1 year ]
    The one-year recurrence will be counted after complete remission.

  6. The life quality improvement [ Time Frame: 1 year ]
    The life quality improvement will be evaluated by appetite,sleep,pain and mental state.


Eligibility Criteria
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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:

  • 18 Years to 70 Years, Male and female
  • Survival time>12 weeks
  • B cell lymphomas diagnosed by Physical examination,pathological examination,Laboratory tests and imaging tests
  • Chemotherapy failure or recurrent B cell lymphomas
  • Creatinine< 2.5mg/dl
  • Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase< 3 fold of normal level
  • Bilirubin<2.0mg/dl
  • Karnofsky Performance Status>50% at the time of screening
  • Adequate pulmonary, renal, hepatic, and cardiac function
  • Fail in autologous or allogenic haemopoietic stem cell transplantation
  • Free of leukocytes removal contraindications
  • Voluntarily join CAR-T clinical trial
  • Understand and sign written informed consent

Exclusion Criteria:

  • Pregnant or nursing women or women with pregnancy plan in half a year
  • Any infectious disease (HIV, active tuberculosis, ect.)
  • Active hepatitis B, active hepatitis C infection
  • Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte amplification is below 5 fold with the costimulation of cluster of differentiation 3(CD 3)and cluster of differentiation 8(CD 8)
  • Abnormal vital signs or cannot cooperate with the inspectors
  • mental or psychological disease cannot cooperate with treatment and curative effect evaluation
  • Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2(IL-2)
  • General infection or local severe infection, or other infection that is not controlled
  • Dysfunction in lung, heart, kidney and brain
  • Severe autoimmune diseases
  • Other symptoms that are not applicable for CAR-T
Contacts and Locations
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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): NCT03207178


Contacts
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Contact: Xin Wang, M.D. 185-1602-2625 ext +86 wangxin928@163.com
Contact: Jiang Cao, Ph.D. 159-5146-8263 ext +86 zimu05067@163.com

Locations
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China, Jingan
Shanghai Longyao Biotechnology Inc., Ltd. Recruiting
Shanghai, Jingan, China, 200072
Contact: Wang Xin, M.D.    185-1602-2625 ext +86    wangxin928@163.com   
Sponsors and Collaborators
Shanghai Longyao Biotechnology Inc., Ltd.
Xuzhou Medical University
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Shengqin Ye, M.D. Shanghai Longyao Biotechnology Inc., Ltd.
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shanghai Longyao Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT03207178    
Other Study ID Numbers: LYCT-1701
First Posted: July 2, 2017    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No