CD19-targeted CAR-T Cell Therapy for MRD+ B-cell Malignancies After Autologous Stem Cell Transplantation
NCT ID: NCT03564977
Last Updated: 2018-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2018-07-15
2020-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19-targeted CAR-T cells
CD19-targeted CAR-T cells
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
Interventions
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CD19-targeted CAR-T cells
MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Yake Biotechnology Ltd.
INDUSTRY
Qingdao Central Hospital
OTHER
Responsible Party
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Locations
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Qingdao Central Hospital
Qingdao, Shandong, China
Countries
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Central Contacts
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Ketao Lana
Role: CONTACT
Facility Contacts
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Other Identifiers
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QingdaoCH201805
Identifier Type: -
Identifier Source: org_study_id
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