Status:
UNKNOWN
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
Shenzhen University
Shenzhen University General Hospital
Conditions:
Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04012892
Start Date
May 1 2019
End Date
June 1 2021
Last Update
July 9 2019
Active Locations (1)
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1
Shenzhen University General Hospital
Shenzhen, China, 518000