Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL
NCT ID: NCT02546739
Last Updated: 2021-01-26
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
PHASE1
100 participants
INTERVENTIONAL
2021-03-01
2023-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental: 1
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Experimental: 2
Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Experimental: 3
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19.
Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Interventions
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Anti-CD19-CAR
Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
Eligibility Criteria
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Inclusion Criteria
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 18 years to 70 years.
5. CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to trial.
Exclusion Criteria
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
18 Years
70 Years
ALL
No
Sponsors
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The First Hospital of Jilin University
OTHER
Hebei Yanda Ludaopei Hospital
OTHER
Beijing Doing Biomedical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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li gangyi, master
Role: STUDY_CHAIR
Beijing Doing Biomedical Co., Ltd.
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Hebei Yanda Ludaopei Hospital
Sanhe, Hebei, China
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huai'An First People'S Hospital
Huaian, Jiangsu, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Shanxi Dayi Hospital
Taiyuan, Shanxi, China
Tianjin people's hospital
Tianjin, Tianjin Municipality, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, China
Beijing DOING Biomedical Co., Ltd
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Gai liyun, Doctor
Role: primary
Other Identifiers
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Doing-002
Identifier Type: -
Identifier Source: org_study_id
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