Back to resultsImmunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
Primary Purpose
Recurrent B-Cell Tumor, Refractory B-Cell Tumor
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19-specific chimeric antigen receptor
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent B-Cell Tumor focused on measuring Recurrent B-Cell Tumor, Refractory B-Cell Tumor, New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T Cells, safety, prognosis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years old, male or female
- Karnofsky≥60%
- At least 2 courses of chemotherapy were performed
- Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
- Adequate venous access, isolation, and white blood cell production without other taboos
- Signed informed consent
- Patients with fertility are willing to use contraceptive method.
- At least two months after infusion of T cells
Exclusion Criteria:
- Need to use glucocorticoid therapy
- Need immunotherapy
- Creatinine > 2.5mg/dL; ALT / AST > 5 times of the normal; bilirubin > 3mg/dL
- Forced expiratory volume at one second (FEV1)<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)<40%
- congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO<40%
- human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
- Had received gene therapy
- Significant encephalopathy / new focal neurologic impairment
- Blood culture positive or radiographic evidence of infection
- Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
- The history of allergic reactions in cell therapy and cetuximab similar compounds.
Sites / Locations
- Eastern Hepatobiliary Surgery HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19-specific chimeric antigen receptor
Arm Description
After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.
Outcomes
Primary Outcome Measures
Occurrence of adverse events and tumor response rate related to study drug
Secondary Outcome Measures
Full Information
NCT ID
NCT02644655
First Posted
December 12, 2015
Last Updated
December 31, 2015
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02644655
Brief Title
Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
Official Title
A Clinical Study Using Autologous T Cell Engineered With Chimeric Antigen Receptor Targeting to CD19（Cluster of Differentiation Antigen 19) in Treating Patients With Recurrent /Refractory B Cell Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Military Medical University
4. Oversight
5. Study Description
Brief Summary
Objectives:
The purpose of this study is to evaluate the safety and prognosis of New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T (nCAR19-T) Cells in the treatment of recurrent/refractory B-cell tumor and the Optimal dosage of nCAR19-T cell therapy.
Methods:
This study designs a novel therapy using nCAR19-T. 20 patients will be enrolled. Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day-6,-5,-4,-3); nCAR19-T transfusion：day 0(5×10※5/kg，1×10※6/kg，3×10※6/kg). According to the National Cancer Institute (NCI) standard (CTCAE), they will be observed 24 weeks long. Follow-up survey after the clinical study: within 1 months, once a week; then once a month for 1 years; and then once a year, a total of 15 years.
Detailed Description
A total of 20 patients may be enrolled over a period of 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent B-Cell Tumor, Refractory B-Cell Tumor
Keywords
Recurrent B-Cell Tumor, Refractory B-Cell Tumor, New Cluster of Differentiation Antigen 19-chimeric Antigen Receptor T Cells, safety, prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19-specific chimeric antigen receptor
Arm Type
Experimental
Arm Description
After pretreatment, cluster of differentiation antigen 19 (CD19)-specific chimeric antigen receptor will be transfused.
Intervention Type
Biological
Intervention Name(s)
CD19-specific chimeric antigen receptor
Intervention Description
Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day 6, 5, 4, 3); nCAR19-T transfusion：day 0(5×105/kg，1×106/kg，3×106/kg).
Primary Outcome Measure Information:
Title
Occurrence of adverse events and tumor response rate related to study drug
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years old, male or female
Karnofsky≥60%
At least 2 courses of chemotherapy were performed
Creatinine is less than 2.5mg/dL;alanine aminotransferase (ALT) / aspartate aminotransferase(AST) less than 3 times of the normal bilirubin is less than 3mg/dL
Adequate venous access, isolation, and white blood cell production without other taboos
Signed informed consent
Patients with fertility are willing to use contraceptive method.
At least two months after infusion of T cells
Exclusion Criteria:
Need to use glucocorticoid therapy
Need immunotherapy
Creatinine > 2.5mg/dL; ALT / AST > 5 times of the normal; bilirubin > 3mg/dL
Forced expiratory volume at one second (FEV1)<2 L,diffusing capacity of the lung for carbon monoxide (DLCO)<40%
congestive cardiac failure (III or IV, NYHA); Significant hypotension; Coronary heart disease Can not be controlled; DLCO<40%
human immunodeficiency virus (HIV), hepatitis B virus (HBV),hepatitis C virus (HCV) patients
Had received gene therapy
Significant encephalopathy / new focal neurologic impairment
Blood culture positive or radiographic evidence of infection
Other drugs, or other biological treatment, chemotherapy or radiotherapy are performed within a month
The history of allergic reactions in cell therapy and cetuximab similar compounds.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qijun Qian, PHD
Phone
+86-21-65580677
Email
qianqj@sino-gene.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@Hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
Organizational Affiliation
Eastern Hepatobiliary Surgery Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Eastern Hepatobiliary Surgery Hospital
City
Shanghai
ZIP/Postal Code
200438
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
Phone
+86-21-81875372
Email
hj-jin@hotmail.com
First Name & Middle Initial & Last Name & Degree
Qijun Qian, PHD
First Name & Middle Initial & Last Name & Degree
Huajun Jin, PHD
First Name & Middle Initial & Last Name & Degree
Zhengang Yuan, PHD
First Name & Middle Initial & Last Name & Degree
Yao Huang, MD
First Name & Middle Initial & Last Name & Degree
Fuping Zhou, MD
First Name & Middle Initial & Last Name & Degree
Yongmei Ding, MD
12. IPD Sharing Statement
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Immunotherapy Using Autologous T Cell-Engineered With CD19-specific Chimeric Antigen Receptor for the Treatment of Recurrent /Refractory B Cell Leukemia
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