Back to resultsCART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
Primary Purpose
Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CART19 cell and auto-HSCT
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Acute, B-Cell
Eligibility Criteria
Inclusion Criteria:
1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:
- AST and ALT ≤ 3 times upper limit of normal range for age,
- Serum creatinine ≤ 1.6 mg/dl,
- Direct bilirubin ≤2.0 mg/dl,
- Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
- 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:
- Active, uncontrolled infection
- Active hepatitis B or hepatitis C
- HIV Infection
- Class III/IV cardiovascular disability according to the New York Heart Association Classification
- Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
- Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
- immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Sites / Locations
- Weihong ChenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: CART19 cell and auto-HSCT
Arm Description
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.
Outcomes
Primary Outcome Measures
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03685786
First Posted
September 24, 2018
Last Updated
December 5, 2018
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03685786
Brief Title
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
Official Title
The Study of Autologous T Cells Expressing CD19 Chimeric Antigen Receptors Treatment of Minimal Residual Disease(MRD) of B Cell Malignancies and Then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 2, 2021 (Anticipated)
Study Completion Date
September 2, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital
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 clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
Detailed Description
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: CART19 cell and auto-HSCT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
CART19 cell and auto-HSCT
Intervention Description
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.
Primary Outcome Measure Information:
Title
CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
Description
The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment
Time Frame
day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as:
AST and ALT ≤ 3 times upper limit of normal range for age,
Serum creatinine ≤ 1.6 mg/dl,
Direct bilirubin ≤2.0 mg/dl,
Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia,
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:
Active, uncontrolled infection
Active hepatitis B or hepatitis C
HIV Infection
Class III/IV cardiovascular disability according to the New York Heart Association Classification
Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment
Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other
immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weihong Chen, M.D., Ph.D.
Phone
0086-755-83366388
Ext
8199
Email
whitney-cindy@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Du, M.D., Ph.D.
Phone
0086-755-83366388
Ext
8197
Email
duxingz@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weihong Chen, M.D., Ph.D.
Organizational Affiliation
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin Du, M.D., Ph.D.
Organizational Affiliation
The second people's hospital of Shenzhen, The first affiliated hospital of Shenzhen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaochun Wan, Ph.D.
Organizational Affiliation
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weihong Chen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weihong Chen, M.D.,Ph.D.
Phone
0086-755-83366388
Ext
8199
Email
whitney-cindy@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xin Du, M.D.,Ph.D.
Phone
0086-755-83366388
Ext
8197
Email
duxingz@medmail.com.cn
12. IPD Sharing Statement
Citations:
PubMed Identifier
35126471
Citation
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.
Results Reference
derived
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CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT
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