CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
Primary Purpose
Lymphoma, B-Cell, Leukemia, B-Cell, Minimal Disease, Residual
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CD19-targeted CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, B-Cell focused on measuring CAR-T, minimal residual disease, B cell maliganacy
Eligibility Criteria
Inclusion Criteria:
- Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
- Age 18 to 75 years old, both male and female;
- Is expected to survive more than 3 months;
- Physical condition is good: ECOG score≤2;
- In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
- General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L;
- No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
- 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:
- 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;
- Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
- Coagulation abnormalities and severe thrombosis;
- Pregnancy and lactation women;
- Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
- The Investigator believe the patients should not participate in this experiment.
Sites / Locations
- Qingdao Central HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19-targeted CAR-T cells
Arm Description
Outcomes
Primary Outcome Measures
Objective response rate
Disease control rate
Overall survival
Progress-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT03564977
First Posted
June 11, 2018
Last Updated
June 28, 2018
Sponsor
Qingdao Central Hospital
Collaborators
Yake Biotechnology Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03564977
Brief Title
CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
Official Title
CD19-targeted CAR-T Cell Therapy for Minimal Residual Disease in B-cell Malignancies After Autologous Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2018 (Anticipated)
Primary Completion Date
June 15, 2020 (Anticipated)
Study Completion Date
June 15, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qingdao Central Hospital
Collaborators
Yake Biotechnology Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, B-Cell, Leukemia, B-Cell, Minimal Disease, Residual
Keywords
CAR-T, minimal residual disease, B cell maliganacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19-targeted CAR-T cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CD19-targeted CAR-T cells
Intervention Description
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
Primary Outcome Measure Information:
Title
Objective response rate
Time Frame
2 years
Title
Disease control rate
Time Frame
2 years
Title
Overall survival
Time Frame
2 years
Title
Progress-free survival
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed by pathological biopsy in patients with B-cell malignancies and treated by autologous stem cell transplantation.
Age 18 to 75 years old, both male and female;
Is expected to survive more than 3 months;
Physical condition is good: ECOG score≤2;
In group of four weeks before Canon imaging examination evaluation body tumor load, recommend line PET - CT examination.
General requirements autologous as basic, normal blood T lymphocytes in autologous count must >= 0.2 x10^9 / L;
No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
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:
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;
Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution;
Coagulation abnormalities and severe thrombosis;
Pregnancy and lactation women;
Any other chronic disease patients who have been treated with immune agents or hormone therapy;
Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
The Investigator believe the patients should not participate in this experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peng Zhao, doctor
Phone
8653284961737
Email
zp8102@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ketao Lana
Facility Information:
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Zhao, Dr
Email
zp8102@126.com
First Name & Middle Initial & Last Name & Degree
Ling Wang, Dr
Email
wldoctor@126.com
First Name & Middle Initial & Last Name & Degree
Ketao Lan, M.D
First Name & Middle Initial & Last Name & Degree
Xuezhen Ma, M.D
First Name & Middle Initial & Last Name & Degree
Ling Wang, M.D
12. IPD Sharing Statement
Learn more about this trial
CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
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