Back to resultsCD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
Primary Purpose
Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Adult
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CD19-CAR-T2 Cells
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia, in Relapse focused on measuring acute lymphoblastic leukemia, minimal residual disease, CAR-T
Eligibility Criteria
Inclusion Criteria:
- Patient with CD19 positive B-cell acute leukemia
- Eastern Cooperative Oncology Group (ECOG) performance status <2
- ALT/ AST <3 x normal
- Bilirubin < 2.0 mg/dl
- Creatinine < 2.5 mg/dl and less than 2.5x normal for age
- LVEF< 45%
- Accept white blood cell collection
- Provide informed consent
Exclusion Criteria:
- Previous treatment with investigational gene or cell therapy medicine products
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Presence of grade 2-4 acute or extensive chronic GVHD
- Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
- Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- Received non-diagnostic purposes major surgery within the past 4 weeks
- Participated in any other clinical study within the past 4 weeks
- Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
- Pregnancy or breast-feeding women
- Use of prohibited drugs:
- Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
- Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
- GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
- Any situation that may increase the risk of the test or interfere with the test results
Sites / Locations
- Nanfang Hospital, Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T group
Arm Description
Outcomes
Primary Outcome Measures
ORR
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Secondary Outcome Measures
ORR
ORR
Adverse Events
OS
overall survival
DFS
disease-free survival
Full Information
NCT ID
NCT04605666
First Posted
October 25, 2020
Last Updated
March 16, 2023
Sponsor
Nanfang Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04605666
Brief Title
CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
Official Title
CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical 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
Relapsed and refractory B cell acute lymphoblastic leukemia (B-ALL) shows unfavorable prognosis, especially for adult patients. Besides, minimal residual disease (MRD) positive at transplant has been considered risk factor for relapse after transplantation. Worse yet, there is no standard management for these patients. Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of chimeric antigen receptor 19 (CD19-CAR-T2 Cells) infusions in patients with CD19+ ALL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphoblastic Leukemia Not Having Achieved Remission, Acute Lymphoblastic Leukemia, Adult
Keywords
acute lymphoblastic leukemia, minimal residual disease, CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CD19-CAR-T2 Cells
Intervention Description
CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.
Primary Outcome Measure Information:
Title
ORR
Description
Overall Response Rate includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi), as determined by assessments of peripheral blood, bone marrow, CNS symptoms, physical exam (PE) and CSF. The primary endpoint will be based on the IRC assessment. The local investigator's assessed results will be used for sensitivity analysis.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
ORR
Time Frame
6 months
Title
ORR
Time Frame
12 months
Title
Adverse Events
Time Frame
12 months
Title
OS
Description
overall survival
Time Frame
1 year
Title
DFS
Description
disease-free survival
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with CD19 positive B-cell acute leukemia
Eastern Cooperative Oncology Group (ECOG) performance status <2
ALT/ AST <3 x normal
Bilirubin < 2.0 mg/dl
Creatinine < 2.5 mg/dl and less than 2.5x normal for age
LVEF< 45%
Accept white blood cell collection
Provide informed consent
Exclusion Criteria:
Previous treatment with investigational gene or cell therapy medicine products
Active hepatitis B , hepatitis C or HIV infection
Uncontrolled active infection
Presence of grade 2-4 acute or extensive chronic GVHD
Active CNS involvement: epilepsy, paresis, aphasia, stroke, severe head trauma,
Dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, etc.
Any uncontrolled active medical disorder that would preclude participation as outlined.
Received non-diagnostic purposes major surgery within the past 4 weeks
Participated in any other clinical study within the past 4 weeks
Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
Pregnancy or breast-feeding women
Use of prohibited drugs:
Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior to CD19-CAR-T2 Cells infusion
Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed > 4 weeks prior to CD19-CAR-T2 Cells infusion
GVHD therapies: Any drug used for GVHD must be stopped > 4 weeks prior to CD19-CAR-T2 Cells infusion
Any situation that may increase the risk of the test or interfere with the test results
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ren Lin, MD
Phone
+86-020-62787883
Email
lansinglinren@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qi-fa Liu, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ren Lin, MD
Phone
+86-020-62787883
Email
lansinglinren@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CD19-CAR-T2 Cells for CD19 Positive Acute Lymphoblastic Leukemia
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