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Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory B-cell Lymphoma

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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.

Tracking Information
First Submitted Date  ICMJE June 23, 2017
First Posted Date  ICMJE July 2, 2017
Last Update Posted Date July 2, 2017
Actual Study Start Date  ICMJE March 1, 2017
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
Overall complete remission rate [ Time Frame: Half a year ]
The complete remission rate will be evaluated by routine methods.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2017)
  • The initial effect time [ Time Frame: 1 year ]
    The initial effect time will be recorded.
  • The one-year survival rate [ Time Frame: 1 year ]
    The one-year survival rate will be recorded.
  • 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.
  • The time to disease progression [ Time Frame: 1 year ]
    The time to disease progression will be counted after complete remission.
  • The one-year recurrence [ Time Frame: 1 year ]
    The one-year recurrence will be counted after complete remission.
  • The life quality improvement [ Time Frame: 1 year ]
    The life quality improvement will be evaluated by appetite,sleep,pain and mental state.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sequential Infusion of Anti-CD19 and Anti-CD20 CAR-T Cells Against Relapsed and Refractory B-cell Lymphoma
Official Title  ICMJE Sequential Infusion of Anti-CD19 and Anti-CD20 Chimeric Antigen Receptor(CAR) T Cells Against Relapsed and Refractory B-cell Lymphoma
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Recurrent or Refractory B Cell Malignancy
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Biological: Mixed CD19/CD20 CAR-T Transfer
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 29, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2020
Estimated Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03207178
Other Study ID Numbers  ICMJE LYCT-1701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shanghai Longyao Biotechnology Inc., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shanghai Longyao Biotechnology Inc., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Xuzhou Medical University
  • Shanghai Jiao Tong University School of Medicine
Investigators  ICMJE
Principal Investigator: Shengqin Ye, M.D. Shanghai Longyao Biotechnology Inc., Ltd.
PRS Account Shanghai Longyao Biotechnology Inc., Ltd.
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP