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

This study is currently recruiting participants.
Verified June 2017 by Shanghai Longyao Biotechnology Inc., Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03207178
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
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.
Collaborators:
Xuzhou Medical University
Shanghai Jiao Tong University School of Medicine
Information provided by (Responsible Party):
Shanghai Longyao Biotechnology Inc., Ltd.
  Purpose
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 Intervention Phase
Recurrent or Refractory B Cell Malignancy Biological: Mixed CD19/CD20 CAR-T Transfer Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Shanghai Longyao Biotechnology Inc., Ltd.:

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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: February 28, 2020
Estimated Primary Completion Date: February 28, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
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
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
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
Principal Investigator: Shengqin Ye, M.D. Shanghai Longyao Biotechnology Inc., Ltd.
  More Information

Publications:
Responsible Party: Shanghai Longyao Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT03207178     History of Changes
Other Study ID Numbers: LYCT-1701
First Submitted: June 23, 2017
First Posted: July 2, 2017
Last Update Posted: July 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents