Back to resultsA Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Primary Purpose
Leukemia, Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Chimeric Antigen Receptor Modified T cells Targeting CD19
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring CAR T, Leukemia, Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
- KPS>60.
- Life expectancy>3 months.
- Gender unlimited, age from 4 years to 75 years.
- Disease progresses but reserves reaction to recent treatments.
- Patients who have failed at least one line of a standard treatment.
- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
Exclusion Criteria:
- HIV affected.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Pregnancy and nursing females.
- Other situations we think improper for the research.
Sites / Locations
- Southwest Hospital of Third Millitary Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Acute Lymphoblastic Leukemia
Chronic Lymphcytic Leukemia
Non-Hodgkin Lymphoma
Arm Description
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
Outcomes
Primary Outcome Measures
Adverse events of each patient.
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Secondary Outcome Measures
Survival time of Anti-CD19 CAR T cells in vivo.
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
To confirm the maximum tolerated dose of CD19 targeted CAR T cells.
Full Information
NCT ID
NCT02349698
First Posted
January 25, 2015
Last Updated
June 23, 2019
Sponsor
Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT02349698
Brief Title
A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Official Title
A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Recruiting
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Detailed Description
Nowadays refractory or relapsed leukemia/lymphoma lacks effective treatment. Innovative therapy is urgently required. Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. To design better CAR T cells, we have developed new CD19 CARs. Preclinical studies have demonstrated effective killing of CD19 target cells. In this study, the CD19 CARs, will be evaluated in CD19 positive leukemia/lymphoma patients. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma
Keywords
CAR T, Leukemia, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acute Lymphoblastic Leukemia
Arm Type
Other
Arm Description
Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
Arm Title
Chronic Lymphcytic Leukemia
Arm Type
Other
Arm Description
Chronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
Arm Title
Non-Hodgkin Lymphoma
Arm Type
Other
Arm Description
Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
Intervention Type
Biological
Intervention Name(s)
Chimeric Antigen Receptor Modified T cells Targeting CD19
Intervention Description
T cells modified with CD19 targeted chimeric antigen receptor.
Primary Outcome Measure Information:
Title
Adverse events of each patient.
Description
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Survival time of Anti-CD19 CAR T cells in vivo.
Description
To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.
Time Frame
3 years
Title
Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells
Time Frame
12 weeks
Title
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
Description
To confirm the maximum tolerated dose of CD19 targeted CAR T cells.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
KPS>60.
Life expectancy>3 months.
Gender unlimited, age from 4 years to 75 years.
Disease progresses but reserves reaction to recent treatments.
Patients who have failed at least one line of a standard treatment.
No serious mental disorder.
Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of >94%, and adequate renal function(Cr≤133umol/L).
No other serious diseases(autoimmune disease, immunodeficiency etc.).
No other tumors.
Patients volunteer to participate in the research.
Exclusion Criteria:
HIV affected.
Patients are allergic to cytokines.
Central nervous system leukemia within 28 days.
Uncontrolled active infection.
Acute or chronic GVHD.
Treated with T cell inhibitor.
Pregnancy and nursing females.
Other situations we think improper for the research.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Qian, MD，PhD
Phone
0086-023-68765461
Email
cqian3184@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi Yang, PhD
Phone
0086-13206140093
Email
Lystch@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Qian, MD, PhD
Organizational Affiliation
Biotherapy Center of Southwest Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Southwest Hospital of Third Millitary Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD
Phone
008615086883400
Email
cqian3184@163.com
First Name & Middle Initial & Last Name & Degree
Zhi Yang, PhD
Phone
008613206140093
First Name & Middle Initial & Last Name & Degree
Cheng Qian, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34513679
Citation
Htun KT, Gong Q, Ma L, Wang P, Tan Y, Wu G, Chen J. Successful Treatment of Refractory and Relapsed CNS Acute Lymphoblastic Leukemia With CD-19 CAR-T Immunotherapy: A Case Report. Front Oncol. 2021 Aug 26;11:699946. doi: 10.3389/fonc.2021.699946. eCollection 2021.
Results Reference
derived
PubMed Identifier
31732519
Citation
Heng G, Jia J, Li S, Fu G, Wang M, Qin D, Li Y, Pei L, Tian X, Zhang J, Wu Y, Xiang S, Wan J, Zhu W, Zhang P, Zhang Q, Peng X, Wang L, Wang P, Wei Z, Zhang Y, Wang G, Chen X, Zhang C, Sun Y, Zhao W, Fan Y, Yang Z, Chen J, Qian C. Sustained Therapeutic Efficacy of Humanized Anti-CD19 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Acute Lymphoblastic Leukemia. Clin Cancer Res. 2020 Apr 1;26(7):1606-1615. doi: 10.1158/1078-0432.CCR-19-1339. Epub 2019 Nov 15.
Results Reference
derived
Learn more about this trial
A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
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