Back to resultsCord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Primary Purpose
Refractory, Relapsed, B Cell Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Refractory
Eligibility Criteria
Inclusion Criteria:
- expected lifespan >3 months
- patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
- KPS >70
- for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
- enough function of heart, liver, kidney and bone marrow
- no history of severy allergy
- no other serious diseases that conflict with this plan
- no other history of malignancy
- no serious mental illness
- patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
Exclusion Criteria:
- pregnant or lactating women
- vevere infectious or viral diseases
- active hepatitis B or C viral hepatitis
- Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
- participated in other clinical studies in the past 3 months or who have been treated with other gene products;
- others that other investigators consider not suitable for this clinical study
Sites / Locations
- Henan Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
cord blood derived CAR T cells group
Outcomes
Primary Outcome Measures
occurrence of study related adverse events
safety of CAR-T cells
Secondary Outcome Measures
objective response rate
the proportion of patients with CR or PR
progression-free survival
from the date of enrollment to the first date of progression detected
overall survival
from the date of enrollment to the date of death
copy number of CAR-T
copy number of CAR-T in blood and bone marrow
Full Information
NCT ID
NCT03881774
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
NCT03881774
Brief Title
Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
Official Title
Clinical Study of Cord Blood Derived CAR-T Cells in Patients With Refractory/Relapsed B Cell Leukemia/Lymphoma Who Are Failed for Autologous CAR-T Cells or Autologous CAR-T Can Not be Prepared
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation the safety and efficacy of cord blood-derived CAR-T cells in patients with relapsed/refractory B cell leukemia/lymphoma whose disease relapsed after autologous CAR-T cells therapy or who fail to preparation for autologous CAR-T cells
Detailed Description
CAR-T cells therapy is the preferred option for relapsed/refractory B cell leukemia/lymphoma. However, some patients will relapse after CAR-T cells therapy, and because of previous multicycles chemotherapy it's very difficult to abtain enough lymphocytes for preparation of antologous CAR-T cells. The exploration of alternative source of lymphocytes for CAR-T cells preparation has important clinical implications for such patients. We evaluated the efficacy and safety of cord blood-derived CAR-T cells in such patients, and to explore effective treatment options for such patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory, Relapsed, B Cell Lymphoma, B Cell Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
CAR-T cell group
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
cord blood derived CAR T cells group
Intervention Type
Biological
Intervention Name(s)
CAR-T cells
Other Intervention Name(s)
cord blood derived CAR-T cells
Intervention Description
collecting cord 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 CAR-T cell with a dose of 0.5-3x106/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
the proportion of patients with CR or PR
Time Frame
three months
Title
progression-free survival
Description
from the date of enrollment to the first date of progression detected
Time Frame
one year
Title
overall survival
Description
from the date of enrollment to the date of death
Time Frame
one year
Title
copy number of CAR-T
Description
copy number of CAR-T in blood and bone marrow
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
expected lifespan >3 months
patients with refractory/relapsed B cell leukemia/lymphoma whose diseases relapse after autologous CAR-T cells or the preparation for autologous CAR-T cells fails
KPS >70
for patients with lymphoma, at least one measurable lesion according to RECIST 1.1
enough function of heart, liver, kidney and bone marrow
no history of severy allergy
no other serious diseases that conflict with this plan
no other history of malignancy
no serious mental illness
patients and their families members agree to participate in this clinical study and sign the Informed Consent Form
Exclusion Criteria:
pregnant or lactating women
vevere infectious or viral diseases
active hepatitis B or C viral hepatitis
Patients who have used large amounts of glucocorticoids or other immunosuppressive agents within the last 4 weeks
participated in other clinical studies in the past 3 months or who have been treated with other gene products;
others that other investigators consider not suitable for this clinical study
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
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
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongping Song, M.D
Phone
+86-37165587795
Email
songyongping2018@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cord Blood Derived CAR-T Cells in Refractory/Relapsed B Cell Malignancies
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