NCT06479356 CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
| NCT ID | NCT06479356 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Ming Ju Biotechnology Co., Ltd. |
| Condition | Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-08-15 |
| Primary Completion | 2025-04-30 |
Trial Parameters
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Brief Summary
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years old; 2. Sign on the informed consent; 3. Subjects must have histologically confirmed Large B-cell Lymphoma; 4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT); 5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; 6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1; 7. Adequate organ function; 8. Adequate vascular access for leukapheresis procedure; 9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; 10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel; 11. Males who have partners of childbearing potential must a