Back to resultsStudy Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Primary Purpose
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 CART
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed Non-Hodgkin Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
- Age 18 to 65 years old, both male and female;
- Is expected to survive more than 12 weeks;
- Physical condition is good: 0-1 score ECOG score;
- No obvious abnormal heart, liver, kidney, 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:
- 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;
- Pregnancy and lactation women;
- 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
- Shenzhen University General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
study group
Arm Description
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
Outcomes
Primary Outcome Measures
recovery rate of patients being treated with CD19CAR-T
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
Secondary Outcome Measures
Full Information
NCT ID
NCT04012892
First Posted
June 28, 2019
Last Updated
July 7, 2019
Sponsor
Chinese PLA General Hospital
Collaborators
Shenzhen University, Shenzhen University General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04012892
Brief Title
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Official Title
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
Collaborators
Shenzhen University, Shenzhen University General Hospital
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 study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
Intervention Type
Combination Product
Intervention Name(s)
CD19 CART
Intervention Description
CD19 CART
Primary Outcome Measure Information:
Title
recovery rate of patients being treated with CD19CAR-T
Description
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
Age 18 to 65 years old, both male and female;
Is expected to survive more than 12 weeks;
Physical condition is good: 0-1 score ECOG score;
No obvious abnormal heart, liver, kidney, 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:
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;
Pregnancy and lactation women;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lixing Wang, MD
Phone
86-0755-21839178
Email
wanglixin1991@sohu.com
Facility Information:
Facility Name
Shenzhen University General Hospital
City
Shenzhen
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lixing Wang, M.D.
Phone
86-0755-21839178
Email
wanglixin1991@sohu.com
First Name & Middle Initial & Last Name & Degree
Li Yu, M.D. Ph.D.
First Name & Middle Initial & Last Name & Degree
Lixing Wang, M.D
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
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