Back to resultsCAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Primary Purpose
B-cell Acute Lymphocytic Leukemia
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Acute Lymphocytic Leukemia focused on measuring CNS B cell acute lymphocytic leukemia
Eligibility Criteria
Inclusion Criteria:
- Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- ALT/ AST 《 3x normal
- Creatinine 《 3x normal
- Age:10-60.
- Signed informed consent
Exclusion Criteria:
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Pregnancy or breast-feeding women
- Survival less than four weeks
Sites / Locations
- The First Affiliated Hospital of Soochow UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
Outcomes
Primary Outcome Measures
The complete remission (CR) rate
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Secondary Outcome Measures
Full Information
NCT ID
NCT03064269
First Posted
February 18, 2017
Last Updated
January 11, 2023
Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT03064269
Brief Title
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Official Title
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
February 18, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Collaborators
The First Affiliated Hospital of Soochow University
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
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
Detailed Description
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphocytic Leukemia
Keywords
CNS B cell acute lymphocytic leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Open Label
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia.
Intervention Type
Biological
Intervention Name(s)
CD19 CAR-T cells
Intervention Description
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
Primary Outcome Measure Information:
Title
The complete remission (CR) rate
Description
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Time Frame
Participants will be followed for the duration of the treatment, an expected average of 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
ALT/ AST 《 3x normal
Creatinine 《 3x normal
Age:10-60.
Signed informed consent
Exclusion Criteria:
Active hepatitis B , hepatitis C or HIV infection
Uncontrolled active infection
Pregnancy or breast-feeding women
Survival less than four weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sheng-Li Xue, MD
Phone
86-13328008851
Email
slxue@suda.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lei Yu, Ph.D
Phone
86-13818629089
Email
ylyh188@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheng-Li Xue, Ph.D
Organizational Affiliation
The First Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-Li Xue, Ph.D
Phone
86-13328008851
Email
slxue@suda.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32745961
Citation
Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
Results Reference
derived
Learn more about this trial
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
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