Back to resultsCD19-targeting CAR T Cells for B Cell Lymphoma
Primary Purpose
B Cell Lymphoma
Status
Withdrawn
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19-targeting CAR T Cells infusion
Sponsored by
About this trial
This is an interventional treatment trial for B Cell Lymphoma focused on measuring CD19, CAR T Cells, Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory CD19+ B-cell lymphoma.
- Measurable disease.
- Performance status ECOG 0-2.
- Age:18-80.
- Fertile females/males must consent to use contraceptives during participation of the trial.
- Signed informed consent
Exclusion Criteria:
- Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
- Patients with primary CNS lymphoma.
- Known human immunodeficiency virus (HIV) infection.
- Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
- Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
- Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
- Patients that do not consent to that tissue and blood samples are stored in a biobank.
- Pregnancy.
Sites / Locations
- Central laboratory in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CAR T cells
No Intervention
Arm Description
In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.
Outcomes
Primary Outcome Measures
CAR T cell persistence
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
Secondary Outcome Measures
Tumor load
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Full Information
NCT ID
NCT02547948
First Posted
September 4, 2015
Last Updated
July 14, 2020
Sponsor
Fuda Cancer Hospital, Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT02547948
Brief Title
CD19-targeting CAR T Cells for B Cell Lymphoma
Official Title
CD19-targeting CAR T Cells for Refractory B Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Withdrawn
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 15, 2016 (Actual)
Study Completion Date
August 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of CD19-targeting CAR T Cells infusion for B Cell Lymphoma.
Detailed Description
Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with B cell lymphoma or leukemia. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and CD28. Autologous T cells will be gene-engineered with the CAR gene using a retrovirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B Cell Lymphoma
Keywords
CD19, CAR T Cells, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CAR T cells
Arm Type
Experimental
Arm Description
In interventional studies, participants are assigned to accept CD19-targeting CAR T Cells infusion so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. Arm refers to each group or subgroup of participants in a clinical trial that receives specfic interventions (or no intervention) according to the study protocol. This is decided before the trial begins.
Arm Title
No Intervention
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
CD19-targeting CAR T Cells infusion
Intervention Description
CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
Primary Outcome Measure Information:
Title
CAR T cell persistence
Description
Presence of circulating CAR T cells will be evaluated with flow cytometry and real time PCR in patient blood
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Tumor load
Description
Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis
Time Frame
up to 24 months
Other Pre-specified Outcome Measures:
Title
B cell number and immunoglobulins
Description
Number of blood B cells and immunoglobulins will be evaluated by routine diagnostics
Time Frame
up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory CD19+ B-cell lymphoma.
Measurable disease.
Performance status ECOG 0-2.
Age:18-80.
Fertile females/males must consent to use contraceptives during participation of the trial.
Signed informed consent
Exclusion Criteria:
Any significant medical or psychiatric illness that would prevent the patient from giving informed consent or from following the study procedures.
Patients with primary CNS lymphoma.
Known human immunodeficiency virus (HIV) infection.
Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection).
Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the patient.
Treatment with an investigational product within 30 days prior to enrollment, or at least 5 half lives of that drug, which is longest.
Patients that do not consent to that tissue and blood samples are stored in a biobank.
Pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PhD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Central laboratory in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
CD19-targeting CAR T Cells for B Cell Lymphoma
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