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CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

RecruitingPhase 2Ages 18 Years - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age no less than 18, no gender limit; 2. Newly diagnosed high-risk Large B-cell Lymphoma, which was defined by the following criteria: (1) DLBCL not otherwise specified with an IPI score ≥3 at diagnosis, (2) high grade B-cell lymphoma (HGBL) with gene rearrangement of MYC and BCL2 and/or BCL6, (3) HGBL not otherwise specified; 3. Confirmed CD19 and CD20 postive expressions in lymphoma cells 4. ECOG score 0-2; 5. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L; 6. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%; 7. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%; 8. Estimated survival time ≥ 3 months; 9. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. Exclusion Criteria: 1. Central nervous system involvement by lymphoma;History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 4. Active infection of hepatitis B virus or hepatitis C virus; 5. Previously treated with any CAR-T cell product or other genetically modified T cell therapies; 6. Insufficient amplification capacity in response to CD3/CD28 co-stimulus signal (\<5 times) ; 7. Other uncontrolled diseases that were not suitable for this trial; 8. Patients with HIV infection; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
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What it tests

  • CD19 CAR-T cells
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Where

1 site
The First Affiliated Hospital,College of Medicine, Zhejiang University
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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