Back to resultsCD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Primary Purpose
B-cell Acute Lymphoblastic Leukemia
Status
Unknown status
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 Lymphoblastic Leukemia focused on measuring B-cell acute lymphoblastic leukemia, CD19 CAR-T
Eligibility Criteria
Inclusion Criteria:
- More than 1 year;
- CD19 positive B-cell acute lymphoblastic leukemia;
- Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
- Expected to survive for more than 3 months;
- Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
- Recent or current use of glucocorticoid or other immunosuppressor;
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Has a graft-versus-host response and requires the use of immunosuppressants；
- Drug uncontrollable central nervous system leukemia；
- Pregnant or lactating female；
- The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
- A history of other malignant tumors;
- The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Sites / Locations
- Hebei Yanda Ludaopei HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19-CAR-T Cells
Arm Description
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Outcomes
Primary Outcome Measures
Percentage of adverse events
Percentage of participants with adverse events
Secondary Outcome Measures
complete remission rate
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
objective remission rate
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).
Full Information
NCT ID
NCT03671460
First Posted
September 11, 2018
Last Updated
September 13, 2018
Sponsor
Tianjin Mycure Medical Technology Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03671460
Brief Title
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Official Title
Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 7, 2018 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Mycure Medical Technology Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed Description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia
Keywords
B-cell acute lymphoblastic leukemia, CD19 CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
single-center, open-label, nonrandomized, no control, prospective clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19-CAR-T Cells
Arm Type
Experimental
Arm Description
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Intervention Type
Biological
Intervention Name(s)
CD19 CAR-T cells
Intervention Description
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Primary Outcome Measure Information:
Title
Percentage of adverse events
Description
Percentage of participants with adverse events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
complete remission rate
Description
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
Time Frame
6 months
Title
objective remission rate
Description
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
More than 1 year;
CD19 positive B-cell acute lymphoblastic leukemia;
Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
Expected to survive for more than 3 months;
Informed consent is signed by a subject or his lineal relation.
Exclusion Criteria:
Recent or current use of glucocorticoid or other immunosuppressor;
Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
Has a graft-versus-host response and requires the use of immunosuppressants；
Drug uncontrollable central nervous system leukemia；
Pregnant or lactating female；
The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
A history of other malignant tumors;
The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaoting Zhang, PhD
Phone
86-010-88196768
Email
zhangchaoting1@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, PhD,MD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, MD, PhD
Phone
18611636172
Email
peihua_lu@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
We don't decide when to share IPD and what will be shared.
Learn more about this trial
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
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