Back to resultsCD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Primary Purpose
B-Cell Lymphoma Stage I, Refractory, Relapsed
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19/CD20 bispecific CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for B-Cell Lymphoma Stage I
Eligibility Criteria
Inclusion Criteria:
- expected lifetime>3 months
- CD19/CD20 positive relapsed/refractory B cell lymphoma
- KPS>70
- at least one measurable lesion according to RECIST 1.1
- enough function of hear, liver, kidney and bone marrow
- no history of severe allergies
- no other history of malignancy
- no other diseases that conflict with this regimen
- no serious mental illness
- patient or family member sign informed consent
Exclusion Criteria:
- Pregnant or lactating women
- Severe infectious or viral disease
- Active B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
- participated in other clinical studies in the last 3 months, or have been treated with other gene products
- Others not appropriate to participate in this study examined by the investigators
Sites / Locations
- Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
CAR-T cell group
Outcomes
Primary Outcome Measures
occurrence of study related adverse events
safety of CAR-T cells
Secondary Outcome Measures
objective response rate
proportion of patients with complete response and partial response
survival time of CAR-T cells in vivo
from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
progression-free survival
the enrollment to the first time that disease progression is detected
Full Information
NCT ID
NCT03881761
First Posted
March 16, 2019
Last Updated
March 19, 2019
Sponsor
Henan Cancer Hospital
Collaborators
Henan Hualong Biotechnology Company
1. Study Identification
Unique Protocol Identification Number
NCT03881761
Brief Title
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Official Title
Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Cancer Hospital
Collaborators
Henan Hualong Biotechnology Company
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
Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma
Detailed Description
CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-Cell Lymphoma Stage I, Refractory, Relapsed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
CAR-T cell group
Intervention Type
Biological
Intervention Name(s)
CD19/CD20 bispecific CAR-T cells
Intervention Description
collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
Primary Outcome Measure Information:
Title
occurrence of study related adverse events
Description
safety of CAR-T cells
Time Frame
one year
Secondary Outcome Measure Information:
Title
objective response rate
Description
proportion of patients with complete response and partial response
Time Frame
three months
Title
survival time of CAR-T cells in vivo
Description
from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo
Time Frame
one year
Title
progression-free survival
Description
the enrollment to the first time that disease progression is detected
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
expected lifetime>3 months
CD19/CD20 positive relapsed/refractory B cell lymphoma
KPS>70
at least one measurable lesion according to RECIST 1.1
enough function of hear, liver, kidney and bone marrow
no history of severe allergies
no other history of malignancy
no other diseases that conflict with this regimen
no serious mental illness
patient or family member sign informed consent
Exclusion Criteria:
Pregnant or lactating women
Severe infectious or viral disease
Active B or C viral hepatitis
Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks
participated in other clinical studies in the last 3 months, or have been treated with other gene products
Others not appropriate to participate in this study examined by the investigators
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongping Song, Dr.
Phone
+86-37165587795
Email
songyongping2018@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Quanli Gao, Dr.
Phone
+86-37165587483
Email
gaoquanli2015@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yongping Song, Dr.
Organizational Affiliation
Henan Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Song, Dr.
Phone
+86-37165587795
Email
songyongping2018@126.com
First Name & Middle Initial & Last Name & Degree
Quanli Gao, Dr.
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quanli Gao, M.D
Phone
+86-15038171966
Email
gaoquanli2015@126.com
First Name & Middle Initial & Last Name & Degree
Lu Han, M.D
Phone
+86-13838583031
Email
luhan0377@163.com
12. IPD Sharing Statement
Learn more about this trial
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
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