Status:
UNKNOWN
Dual Target CAR-T Cells in B-cell Lymphoma
Lead Sponsor:
YuLi
Conditions:
Lymphoma, B-Cell
Relapse/Recurrence
Eligibility:
All Genders
14-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma .
Detailed Description
Prospectively evaluate the safety and effectiveness of CD19/CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell lymphoma . Strictly follow the inclusion criteria to screen elig...
Eligibility Criteria
Inclusion
- Subjects must meet the following criteria to participate in this study:
- 14-75 years old, no gender limit;
- Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
- ECOG behavior status score is 0-2 points;
- Expected survival time ≥ 3 months;
- No contraindications to peripheral apheresis;
- Flow cytometry/immunohistochemistry confirms that tumor cells express CD20;
- Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
- No serious heart, lung, liver or kidney disease;
- Ability to understand and willing to sign the informed consent form for this trial.
Exclusion
- Patients with any of the following cannot be included in this study:
- Tumor cells do not express CD20;
- There is active infection;
- Abnormal liver function (total bilirubin\>1.5×ULN, glutamic-pyruvic transaminase\>2.5×ULN), abnormal renal function (serum creatinine\>1.5×ULN);
- People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
- HIV/AIDS patients;
- Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment;
- Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
- Known or suspected drug abuse or alcohol dependence;
- People with mental illness or other conditions cannot obtain informed consent, and cannot cooperate with the requirements for completing the experimental treatment and inspection procedures;
- Those who have participated in other clinical trials within 30 days;
- Pregnant or lactating women, male subjects (or their partners) or female subjects have a pregnancy plan during the study period to 6 months after the end of the test, and are unwilling to use a medically approved effective contraceptive measure during the test period (Such as intrauterine device or condom);
- The investigator judged that it is not suitable to participate in this trial.
Key Trial Info
Start Date :
October 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04723914
Start Date
October 20 2020
End Date
December 31 2022
Last Update
January 26 2021
Active Locations (1)
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1
Shenzhen University General hospital
Shenzhen, Guangdong, China, 518055