Back to resultsCD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
Primary Purpose
Leukemia, B-cell, Lymphoma, B-Cell
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 and CD22 targeted CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, B-cell focused on measuring CD19, CD22, CAR-T
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent
Diagnose as Relapsed and Refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
- Failed to standard chemotherapy regimens;
- Relapse after complete remission, high-risk and / or refractory patients ;
- Relapse after hematopoietic stem cell transplantation;
- For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
- Evidence for cell membrane CD19 and CD22 expression；
- All genders ，ages: 2 to 75 years；
- The expect time of survive is above 3 months;
- KPS>60；
- No serious mental disorders ;
- Left ventricular ejection fraction ≥50%
- Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
- Sufficient renal function defined by creatinine clearance≤2 x ULN;
- Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
- With single or venous blood collection standards, and no other cell collection contraindications;
- Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
- Previous history of other malignancy;
- Presence of uncontrolled active infection;
- Evidence of disorder that need the treatment by glucocorticoids;
- Active or chronic GVHD；
- The patients treatment by inhibitor of T cell；
- Pregnant or breasting-feeding women;
- Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Sites / Locations
- 920th Hospital of Joint Logistics Support ForceRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm 1
Arm Description
Patients will be be treated with CD19 and CD22 CAR-T cells
Outcomes
Primary Outcome Measures
Adverse events that related to treatment
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
The response rate of CD19 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma
The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Secondary Outcome Measures
Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) rate of CD19 and CD22 CAR-T cells were determined by means of flow cytometry
Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood
In vivo (bone marrow and peripheral blood) quantity of CD19 and CD22 CAR copies were determined by means of qPCR
Cellular kinetics of CD19 and CD22 positive cells in Bone marrow
In vivo (bone marrow) rate and quantity of CD19 and CD22 positive cells were determined by means of flow cytometry
Levels of Cytokines in Serum
In vivo (Serum) quantity of cytokines(IL-6、IL-10、TNF-α、CRP)
Duration of Response (DOR) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
Progress-free survival(PFS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Overall survival(OS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Full Information
NCT ID
NCT04649983
First Posted
August 30, 2020
Last Updated
April 16, 2023
Sponsor
Chongqing Precision Biotech Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04649983
Brief Title
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
Official Title
Safety and Efficacy of CD19 and CD22 Targeted CAR-T Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chongqing Precision Biotech 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 arm study to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cells therapy for patients with relapsed/refractory B Cell Leukemia and Lymphoma.
Detailed Description
Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies. There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, We launch such a clinical trial using CD19 and CD22 targeted CAR-T cells for patients with relapsed and refractory B Cell Leukemia and Lymphoma to evaluate the efficacy and safety of CD19 and CD22 targeted CAR-T cell therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, B-cell, Lymphoma, B-Cell
Keywords
CD19, CD22, CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients will be be treated with CD19 and CD22 CAR-T cells
Intervention Type
Biological
Intervention Name(s)
CD19 and CD22 targeted CAR-T cells
Intervention Description
A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously
Primary Outcome Measure Information:
Title
Adverse events that related to treatment
Description
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Time Frame
2 years
Title
The response rate of CD19 and CD22 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma
Description
The response rate of CD19 and CD22 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rate of CD19 and CD22 CAR-T cells in bone marrow and peripheral blood
Description
In vivo (bone marrow and peripheral blood) rate of CD19 and CD22 CAR-T cells were determined by means of flow cytometry
Time Frame
2 years
Title
Quantity of CD19 and CD22 CAR copies in bone marrow and peripheral blood
Description
In vivo (bone marrow and peripheral blood) quantity of CD19 and CD22 CAR copies were determined by means of qPCR
Time Frame
2 years
Title
Cellular kinetics of CD19 and CD22 positive cells in Bone marrow
Description
In vivo (bone marrow) rate and quantity of CD19 and CD22 positive cells were determined by means of flow cytometry
Time Frame
1 years
Title
Levels of Cytokines in Serum
Description
In vivo (Serum) quantity of cytokines(IL-6、IL-10、TNF-α、CRP)
Time Frame
3 months
Title
Duration of Response (DOR) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Description
DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)
Time Frame
2 years
Title
Progress-free survival(PFS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Description
PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)
Time Frame
2 years
Title
Overall survival(OS) of CD19 and CD22 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma
Description
OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent
Diagnose as Relapsed and Refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
Failed to standard chemotherapy regimens;
Relapse after complete remission, high-risk and / or refractory patients ;
Relapse after hematopoietic stem cell transplantation;
For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
Evidence for cell membrane CD19 and CD22 expression；
All genders ，ages: 2 to 75 years；
The expect time of survive is above 3 months;
KPS>60；
No serious mental disorders ;
Left ventricular ejection fraction ≥50%
Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
Sufficient renal function defined by creatinine clearance≤2 x ULN;
Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
With single or venous blood collection standards, and no other cell collection contraindications;
Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
Previous history of other malignancy;
Presence of uncontrolled active infection;
Evidence of disorder that need the treatment by glucocorticoids;
Active or chronic GVHD；
The patients treatment by inhibitor of T cell；
Pregnant or breasting-feeding women;
Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, PhD
Phone
86-13206140093
Email
yangzhi@precision-biotech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sanbin Wang, MD
Email
Sanbin1011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD
Organizational Affiliation
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD
Organizational Affiliation
Chongqing University Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
920th Hospital of Joint Logistics Support Force
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD
Email
Sanbin1011@163.com
First Name & Middle Initial & Last Name & Degree
Sanbin Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
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