Back to resultsC-CAR011 Treatment in Subjects With ALL After HSCT
Primary Purpose
Acute Lymphoblastic Leukemia(ALL)
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
C-CAR011
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia(ALL) focused on measuring Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell
Eligibility Criteria
Inclusion Criteria:
- Age 15-65 years old, male or female.
- Volunteered to participate in this study and signed informed consent.
- Meet the two populations above.
- Histologically diagnosed as CD19+B-ALL.
- 100% T lymphocytes of donor.
- Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
- Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
- Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
- Expected survival ≧ 3 months.
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
- History of allergy to cellular products.
- Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
- The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
- Severe uncontrolled infection (mycotic, bacterial, virus and so on).
- Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
- The subjects were treated CART cells or DLI after HSCT.
- Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
- Any genetically modified T cell therapy.
- History of heavy drinking, drug taking or mental disease.
- Participated in any other clinical trial within one month prior to enrollment.
- Women who are pregnant or lactating or have breeding intent in 6 months.
- The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Sites / Locations
- Peking University Institute of Hematology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
C-CAR011
Arm Description
The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg
Outcomes
Primary Outcome Measures
TEAEs
TEAEs evaluated after C-CAR011 infusion
GVHD
GVHD evaluated after C-CAR011 infusion
Secondary Outcome Measures
Recurrence rate
Recurrence rate
OS
Overall survival (OS) after C-CAR011 infusion
PFS
Progression free survival（PFS）after C-CAR011 infusion
Remission rate
MRD negative after C-CAR011 infusion
Full Information
NCT ID
NCT03327285
First Posted
August 17, 2017
Last Updated
September 30, 2020
Sponsor
Peking University People's Hospital
Collaborators
Cellular Biomedicine Group Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03327285
Brief Title
C-CAR011 Treatment in Subjects With ALL After HSCT
Official Title
A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Cellular Biomedicine Group Ltd.
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 is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT
Detailed Description
A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia(ALL)
Keywords
Acute lymphoblastic leukemia, Hematopoietic stem cell transplantation, Anti-CD19 chimeric antigen receptor T-cell
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C-CAR011
Arm Type
Experimental
Arm Description
The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg
Intervention Type
Biological
Intervention Name(s)
C-CAR011
Other Intervention Name(s)
Anti-CD19 chimeric antigen receptor T cells (C-CAR011)
Intervention Description
CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)
Primary Outcome Measure Information:
Title
TEAEs
Description
TEAEs evaluated after C-CAR011 infusion
Time Frame
2 months
Title
GVHD
Description
GVHD evaluated after C-CAR011 infusion
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
Recurrence rate
Time Frame
6 and 12 months
Title
OS
Description
Overall survival (OS) after C-CAR011 infusion
Time Frame
12 months
Title
PFS
Description
Progression free survival（PFS）after C-CAR011 infusion
Time Frame
12 months
Title
Remission rate
Description
MRD negative after C-CAR011 infusion
Time Frame
2 weeks to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 15-65 years old, male or female.
Volunteered to participate in this study and signed informed consent.
Meet the two populations above.
Histologically diagnosed as CD19+B-ALL.
100% T lymphocytes of donor.
Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
Expected survival ≧ 3 months.
Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
History of allergy to cellular products.
Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
Severe uncontrolled infection (mycotic, bacterial, virus and so on).
Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
The subjects were treated CART cells or DLI after HSCT.
Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
Any genetically modified T cell therapy.
History of heavy drinking, drug taking or mental disease.
Participated in any other clinical trial within one month prior to enrollment.
Women who are pregnant or lactating or have breeding intent in 6 months.
The investigators believe that any increase in the risk of the subject or interference with the results of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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C-CAR011 Treatment in Subjects With ALL After HSCT
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