Last updated: January 23, 2021
Sponsor: YuLi
Overall Status: Active - Recruiting
Phase
1/2
Condition
Lymphoma, B-cell
Lymphoma
Treatment
N/AClinical Study ID
NCT04723914
HEM-ONCO-006
Ages 14-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 WorldHealth 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 CD19expression;
- No serious heart, lung, liver or kidney disease;
- Ability to understand and willing to sign the informed consent form for thistrial.
Exclusion
Exclusion Criteria:
- 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-pyruvictransaminase>2.5×ULN), abnormal renal function (serum creatinine>1.5×ULN);
- People with unstable angina or New York Heart Association class 3/4 congestiveheart 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 experimentaltreatment 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 subjectshave a pregnancy plan during the study period to 6 months after the end of thetest, and are unwilling to use a medically approved effective contraceptivemeasure during the test period (Such as intrauterine device or condom);
- The investigator judged that it is not suitable to participate in this trial.
Study Design
Total Participants: 20
Study Start date:
October 20, 2020
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
Shenzhen University General hospital
Shenzhen, Guangdong 518055
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.