Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2020-10-20
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Dual target CAR-T cell therapy
dual target CAR-T cell therapy
CD19/CD20 dual target CAR-T cell therapy
Interventions
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dual target CAR-T cell therapy
CD19/CD20 dual target CAR-T cell therapy
Eligibility Criteria
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Inclusion Criteria
1. 14-75 years old, no gender limit;
2. Diagnosed as relapsed/refractory B-cell lymphoma according to the 2020 World Health Organization (WHO) diagnostic criteria;
3. ECOG behavior status score is 0-2 points;
4. Expected survival time ≥ 3 months;
5. No contraindications to peripheral apheresis;
6. Flow cytometry/immunohistochemistry confirms that tumor cells express CD20;
7. Those who are tolerant to CD19 CAR-T cell therapy or those with low CD19 expression;
8. No serious heart, lung, liver or kidney disease;
9. Ability to understand and willing to sign the informed consent form for this trial.
Exclusion Criteria
1. Tumor cells do not express CD20;
2. There is active infection;
3. Abnormal liver function (total bilirubin\>1.5×ULN, glutamic-pyruvic transaminase\>2.5×ULN), abnormal renal function (serum creatinine\>1.5×ULN);
4. People with unstable angina or New York Heart Association class 3/4 congestive heart failure, multiple organ dysfunction;
5. HIV/AIDS patients;
6. Those who need long-term anticoagulation (warfarin or heparin), antiplatelet (aspirin, dose\>300mg/d; clopidogrel, dose\>75mg/d) treatment;
7. Those who received radiotherapy within 4 weeks before the start of the study (blood sampling);
8. Known or suspected drug abuse or alcohol dependence;
9. 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;
10. Those who have participated in other clinical trials within 30 days;
11. 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);
12. The investigator judged that it is not suitable to participate in this trial.
14 Years
75 Years
ALL
No
Sponsors
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YuLi
OTHER
Responsible Party
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YuLi
Professor
Principal Investigators
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Li Yu, Dr
Role: PRINCIPAL_INVESTIGATOR
Shenzhen University General Hospital
Locations
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Shenzhen University General hospital
Shenzhen, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HEM-ONCO-006
Identifier Type: -
Identifier Source: org_study_id
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