Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia (EECNTL)
Primary Purpose
Leukemia
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CD19-targeted CAR-T cells
Sponsored by

About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia CAR-T
Eligibility Criteria
Inclusion Criteria:
- All patients with acute non T lymphocytic leukemia after conventional treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirm the leukemia cells express can intervene molecular targets;
- Age 3 to 75 years old, both male and female;
- Is expected to survive more than 3 months;
- Physical condition is good: 0-2 score ECOG score;
- General requirements peripheral blood as basic normal (i.e., white blood cells >= 4.0 x10^9 / L, hemoglobin > 100 g/L, the platelet count>= 50 x10^9 / L ), progress faster, in patients with special severe fully inform the patient related risk and gain understanding and consent, peripheral blood cell index can be extended to white blood cells >= 2.0 x10^9 / L, hemoglobin > 60 g/L, the platelet count >= 30 x10^9 / L. But blood T lymphocytes in peripheral blood count must >=0.2 x10^9 / L;
- No obvious abnormal heart, liver and kidney function (namely basic normal ecg; kidney function: Cr <=2.0 x ULN (Upper limit of normal value ); liver function: Alt/aspartate aminotransferase acuities <=2.5 x ULN, BIL<= 2.0 x ULN) , no large wounds that haven't healed on the body;
- Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.
Exclusion Criteria:
- Various types of T lymphocyte leukemia, etc;
- Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
- Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more.
- Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
- Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution.
- Coagulation abnormalities and severe thrombosis;
- Pregnancy and lactation women;
- Any other chronic disease patients who have been treated with immune agents or hormone therapy;
- Patients who have participated in other clinical trials or other clinical trials in the past 30 days
- The Investigator believe the patients should not participate in this experiment.
Sites / Locations
- The Second Hospital of Anhui Medical University
- No. 454 Hospital of People'S Liberation Army
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times
Outcomes
Primary Outcome Measures
The overall efficiency
The number of complete remission (CR) +The number of complete remission with incomplete hematologic recovery (CRi)/Total number of cases being treated
Secondary Outcome Measures
Full Information
NCT ID
NCT02735291
First Posted
March 29, 2016
Last Updated
July 13, 2020
Sponsor
Sinobioway Cell Therapy Co., Ltd.
Collaborators
The Second Hospital of Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02735291
Brief Title
Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia
Acronym
EECNTL
Official Title
Single Arm, Two Phase, Multicenter Trial to Evaluating the Efficacy and Safety of the CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinobioway Cell Therapy Co., Ltd.
Collaborators
The Second Hospital of Anhui Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This single-arm,multicenter Phase 2 trial will treat the patients who have recurrent or refractory acute non T lymphocyte leukemia with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor (CAR) that will bind to tumour cells that express the EPCAM protein on the cell surface.The study will determine if these modified T cells help the body's immune system eliminate tumour cells.The trial will also study the safety of treatment with CAR-T,how long CAR-T cells stay in the patient's body and the impact of this treatment on survival.
Detailed Description
This is a single-arm,multicenter Phase 2 study to evaluate the efficacy and safety of the CAR-T for recurrent or refractory acute non T lymphocyte leukemia.The study will be conducted using a phase I/II design.The study will have the following sequential phases:Part A (screening leukapheresis, cell product preparation, and cytoreductive chemotherapy) and Part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study is expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Leukemia CAR-T
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Arm Description
Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times
Intervention Type
Biological
Intervention Name(s)
CD19-targeted CAR-T cells
Intervention Description
This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months..
Primary Outcome Measure Information:
Title
The overall efficiency
Description
The number of complete remission (CR) +The number of complete remission with incomplete hematologic recovery (CRi)/Total number of cases being treated
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with acute non T lymphocytic leukemia after conventional treatment is invalid or recurrence of refractory, and by flow cytometry or pathological immunohistochemical examination, confirm the leukemia cells express can intervene molecular targets;
Age 3 to 75 years old, both male and female;
Is expected to survive more than 3 months;
Physical condition is good: 0-2 score ECOG score;
General requirements peripheral blood as basic normal (i.e., white blood cells >= 4.0 x10^9 / L, hemoglobin > 100 g/L, the platelet count>= 50 x10^9 / L ), progress faster, in patients with special severe fully inform the patient related risk and gain understanding and consent, peripheral blood cell index can be extended to white blood cells >= 2.0 x10^9 / L, hemoglobin > 60 g/L, the platelet count >= 30 x10^9 / L. But blood T lymphocytes in peripheral blood count must >=0.2 x10^9 / L;
No obvious abnormal heart, liver and kidney function (namely basic normal ecg; kidney function: Cr <=2.0 x ULN (Upper limit of normal value ); liver function: Alt/aspartate aminotransferase acuities <=2.5 x ULN, BIL<= 2.0 x ULN) , no large wounds that haven't healed on the body;
Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.
Exclusion Criteria:
Various types of T lymphocyte leukemia, etc;
Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more.
Patients with significant graft versus host disease (GVHD) after organ transplant history or allogeneic hematopoietic stem cell transplantation;
Systemic autoimmune diseases or immunodeficiency disease, patients with allergic constitution.
Coagulation abnormalities and severe thrombosis;
Pregnancy and lactation women;
Any other chronic disease patients who have been treated with immune agents or hormone therapy;
Patients who have participated in other clinical trials or other clinical trials in the past 30 days
The Investigator believe the patients should not participate in this experiment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhimin Zhai, Professor
Organizational Affiliation
Chief physician
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hui Liao, Doctor
Organizational Affiliation
Chief physician
Official's Role
Study Director
Facility Information:
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Facility Name
No. 454 Hospital of People'S Liberation Army
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33230103
Citation
An F, Wang H, Liu Z, Wu F, Zhang J, Tao Q, Li Y, Shen Y, Ruan Y, Zhang Q, Pan Y, Zhu W, Qin H, Wang Y, Fu Y, Feng Z, Zhai Z. Influence of patient characteristics on chimeric antigen receptor T cell therapy in B-cell acute lymphoblastic leukemia. Nat Commun. 2020 Nov 23;11(1):5928. doi: 10.1038/s41467-020-19774-x.
Results Reference
derived
Learn more about this trial
Study Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia
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