NCT04661020 CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
| NCT ID | NCT04661020 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Zhejiang University |
| Condition | Large B-Cell Lymphoma (LBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2020-12-03 |
| Primary Completion | 2026-12-20 |
Trial Parameters
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Brief Summary
A Study of CD19 CAR-T Therapy for Patients With Newly Diagnosed High-risk Large B-cell Lymphoma
Eligibility Criteria
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 is