CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
NCT ID: NCT03685786
Last Updated: 2018-12-07
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
20 participants
INTERVENTIONAL
2018-06-01
2021-09-02
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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Experimental: CART19 cell and auto-HSCT
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
CART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
Interventions
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CART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
Eligibility Criteria
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Inclusion Criteria
1. AST and ALT ≤ 3 times upper limit of normal range for age,
2. Serum creatinine ≤ 1.6 mg/dl,
3. Direct bilirubin ≤2.0 mg/dl,
4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
Exclusion Criteria
2. Active hepatitis B or hepatitis C
3. HIV Infection
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification
5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
14 Years
75 Years
ALL
No
Sponsors
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Shenzhen Second People's Hospital
OTHER
Responsible Party
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Principal Investigators
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Weihong Chen, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xin Du, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Xiaochun Wan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
Locations
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Weihong Chen
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Weihong Chen, M.D.,Ph.D.
Role: primary
Xin Du, M.D.,Ph.D.
Role: backup
References
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Zhou W, Chen W, Wan X, Luo C, Du X, Li X, Chen Q, Gao R, Zhang X, Xie M, Wang M. Benefits of Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma. Front Genet. 2022 Jan 20;12:815679. doi: 10.3389/fgene.2021.815679. eCollection 2021.
Other Identifiers
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Weihong Chen06062018
Identifier Type: -
Identifier Source: org_study_id