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CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation

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: NCT03564977
Recruitment Status : Unknown
Verified June 2018 by Qingdao Central Hospital.
Recruitment status was:  Recruiting
First Posted : June 21, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Yake Biotechnology Ltd.
Information provided by (Responsible Party):
Qingdao Central Hospital

Study Description
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Brief Summary:
The main purpose of this study is to explore the efficacy of CD19-targeted CAR-T cell therapy for minimal residual disease (MRD) in B-cell Malignancies after autologous stem cell transplantation.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Leukemia, B-Cell Minimal Disease, Residual Biological: CD19-targeted CAR-T cells Not Applicable

Detailed Description:
Relapse is a common cause of failure in patients with B-cell malignancies after autologous stem cell transplantation. CD19-targeted CAR-T cells showed excellent therapeutic efficiency in B-cell malignancies. Investigators attempt to treat minimal residual disease (MRD)-positive B-cell Malignancies after autologous stem cell transplantation by CD19-targeted CAR-T cells and hope to explore the therapeutic effects of CD19-targeted CAR-T cell therapy.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
Estimated Study Start Date : July 15, 2018
Estimated Primary Completion Date : June 15, 2020
Estimated Study Completion Date : June 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CD19-targeted CAR-T cells Biological: CD19-targeted CAR-T cells
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate [ Time Frame: 2 years ]
  2. Disease control rate [ Time Frame: 2 years ]
  3. Overall survival [ Time Frame: 2 years ]
  4. Progress-free survival [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
  2. Age 18 to 75 years old, both male and female;
  3. Is expected to survive more than 3 months;
  4. Physical condition is good: ECOG score≤2;
  5. In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
  6. General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L;
  7. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
  8. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

  1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
  2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
  3. Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
  4. Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
  5. Coagulation abnormalities and severe thrombosis;
  6. Pregnancy and lactation women;
  7. Any other chronic disease patients who have been treated with immune agents or hormone therapy;
  8. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
  9. The Investigator believe the patients should not participate in this experiment.
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): NCT03564977


Contacts
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Contact: Peng Zhao, doctor 8653284961737 zp8102@126.com
Contact: Ketao Lana

Locations
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China, Shandong
Qingdao Central Hospital Recruiting
Qingdao, Shandong, China, 266042
Contact: Peng Zhao, Dr       zp8102@126.com   
Contact: Ling Wang, Dr       wldoctor@126.com   
Principal Investigator: Ketao Lan, M.D         
Sub-Investigator: Xuezhen Ma, M.D         
Sub-Investigator: Ling Wang, M.D         
Sponsors and Collaborators
Qingdao Central Hospital
Yake Biotechnology Ltd.
More Information
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Responsible Party: Qingdao Central Hospital
ClinicalTrials.gov Identifier: NCT03564977    
Other Study ID Numbers: QingdaoCH201805
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qingdao Central Hospital:
CAR-T
minimal residual disease
B cell maliganacy
Additional relevant MeSH terms:
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Neoplasm, Residual
Lymphoma, B-Cell
Leukemia, B-Cell
Neoplasms
Neoplastic Processes
Pathologic Processes
Lymphoma, Non-Hodgkin
Lymphoma
 Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia