Back to resultsA Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
Primary Purpose
Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T19/CAR-T22
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
- no available curative treatment options (such as autologous or allogeneic SCT)
- If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
- Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
- Patients must be willing to sign an informed consent.
- Age:≤18 years.
- survival>12 weeks
- Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
- Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
- Liver function: ALT and AST≤2.5 (ULN) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 ULN), bilirubin <2.0 mg/dl.
- Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
- Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
- Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
- ECOG score ≤2。
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
Exclusion Criteria:
- ECOG >= 3.
- Patients with history of T cell tumors .
- organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
- Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
- steroid hormoneswere used before and after blood collection and infusion.
- HIV infection or active hepatitis B or hepatitis C infection.
- Uncontrolled active infection.
- Enrolled to other clinical study in the last 4 weeks.
- Subjects with systemic auto-immune disease or immunodeficiency.
- Allergic to cytokines.
- Definite neuropathic or psychotic patients, including authors of dementia or seizures, history of psychotropic substance abuse and unable to quit, or other substantial lesions that may increase central neurotoxicity.
- Patients with malignant tumors of the central nervous system.
- Lung, brain or intestinal tumor infiltrates.
- The second tumor was found.
- Allergic to cytokine antagonists.
- Other patients that researchers considered unsuitable for inclusion.
Sites / Locations
- Xiangya Hospital Central South UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CAR-T19/CAR-T22
Arm Description
CAR-T19/CAR-T22 (autologous T cells transduced with CD19 / 22 CAR-ζ/4-1BB vector) will be administered to children with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Safety evaluation
Secondary Outcome Measures
Overall remission rate
Overall remission rate consists of complete remission rate and partial remission rate of patients being treated with CAR-T19/CAR-T22
CAR-T cells testing
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Full Information
NCT ID
NCT04204161
First Posted
December 13, 2019
Last Updated
February 3, 2021
Sponsor
Shenzhen BinDeBio Ltd.
Collaborators
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04204161
Brief Title
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
Official Title
A Clinical Study Evaluating the Safety and Efficacy of CAR-T19/CAR-T22 Treatment for Children With CD19 Positive Relapse or Refractory Childhood Acute Lymphoblastic Leukemia and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 8, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen BinDeBio Ltd.
Collaborators
Xiangya Hospital of Central South 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 is a single arm, open-label, uni-center, phase I study . In this study, Children withCD19+/CD22+ R/R B-cell acute lymphoblastic leukemia or lymphoma will be treated with CAR-T19/CAR-T22 Immunotherapy to determine the safety and efficacy of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed B-cell Acute Lymphoblastic Leukemia, Childhood, Refractory B-cell Acute Lymphoblastic Leukemia, Childhood, Relapsed/Refractory B-cell Lymphoma, Childhood
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T19/CAR-T22
Arm Type
Experimental
Arm Description
CAR-T19/CAR-T22 (autologous T cells transduced with CD19 / 22 CAR-ζ/4-1BB vector) will be administered to children with R/R B cell Acute Lymphoblastic Leukemia (ALL) or Lymphoma as an IV infusion on days 0, 1 and 2 in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
CAR-T19/CAR-T22
Intervention Description
According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10^5/kg-2.5x10^8/kg .
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events evaluated with NCI CTC AE, version 4.0
Description
Safety evaluation
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Overall remission rate
Description
Overall remission rate consists of complete remission rate and partial remission rate of patients being treated with CAR-T19/CAR-T22
Time Frame
60 months
Title
CAR-T cells testing
Description
The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female subjects with CD19+/CD22+ B cell malignancies who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled.
no available curative treatment options (such as autologous or allogeneic SCT)
If patients had receive immunotherapy, they should reach requirments:tumor recurrency or the number of B cells recovered.
Patients with recurrence after hematopoietic stem cell transplantation need additional satisfaction: 1) no GvHD and not require immunosuppression;2) stem cell transplantation was completed for at least 4 months, and at least 6 months before the CART reinfusion;
Patients must be willing to sign an informed consent.
Age:≤18 years.
survival>12 weeks
Flow cytometry or IHC showed positive expression of CD19/ CD22 in tumor cells within two months.
Routine blood test:hemoglobin>=90 g/L; platelet>=50×10^9/L.
Liver function: ALT and AST≤2.5 (ULN) times the upper limits of normal (if abnormal liver function is mainly caused by tumor infiltration, it can ≤5 ULN), bilirubin <2.0 mg/dl.
Renal function:BUN: 9-20mg / dl; serum creatinine<= 1.5 times upper limits of normal; endogenous creatinine clearance rate>=50 ml/min
Negative serum antibody for EBV, CMV, HIV , syphilis, HBVa nd HCV.
Cardiac function: stable hemodynamic and left ventricular ejection fraction (LVEF)>=55%.
ECOG score ≤2。
Adequate venous access for apheresis, and no other contraindications for leukapheresis
Exclusion Criteria:
ECOG >= 3.
Patients with history of T cell tumors .
organ failure:heart failure Ⅲ and Ⅳ;The liver reached grade C of child-turcotte .Renal failure and uremia;Respiratory failure;People with impaired consciousness.
Acute or chronic GVHD after allogeneic hematopoiesis. Hormone or immunosuppressant was used within 30 days.
steroid hormoneswere used before and after blood collection and infusion.
HIV infection or active hepatitis B or hepatitis C infection.
Uncontrolled active infection.
Enrolled to other clinical study in the last 4 weeks.
Subjects with systemic auto-immune disease or immunodeficiency.
Allergic to cytokines.
Definite neuropathic or psychotic patients, including authors of dementia or seizures, history of psychotropic substance abuse and unable to quit, or other substantial lesions that may increase central neurotoxicity.
Patients with malignant tumors of the central nervous system.
Lung, brain or intestinal tumor infiltrates.
The second tumor was found.
Allergic to cytokine antagonists.
Other patients that researchers considered unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Zhonghua
Phone
18938688105
Email
zh.yang@bindebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang Zhonghua
Organizational Affiliation
Shenzhen BinDeBio Tech Co.,Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Minghua, PhD
Phone
13973135843
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Study of CAR-T Cells Treatment for Children With CD19+/CD22+ R/R ALL and Lymphoma
We'll reach out to this number within 24 hrs