anti-CD19-CAR-T / Shanghai First Song Therap - LARVOL DELTA

Clinical Evaluation of Fast-in-Time (FIT) Anti-CD19 CAR T—a Non-Viral, 2-Day Rapid Manufacture CAR T-Cell Therapy for B-Cell Malignancies (ASH 2024) - "Three pts received 2-3 days of LD chemotherapy (cyclophosphamide 250 mg/m2/day and fludarabine 25 mg/m2/day) begun within 1 day of apheresis at the investigator's discretion and received fresh (non-frozen) FIT-CD19-CAR T-cells with a 5-day vein-to-vein time, while 1 FL is planned to receive cryopreserved CAR T-cells as per his willingness. In conclusion, FIT-CD19-CAR-T demonstrates a favorable safety profile and encouraging initial efficacy and PK at relative low doses in pts with heavily pretreated B-cell malignancies, which may be attributable to enhanced expression of naïve and stem cell memory markers on rapidly manufactured FIT-CD19-CAR-T cells that were not expanded or activated ex vivo. Phase 1 studies are planned for continued investigation."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Disorders • Hematological Malignancies • Oncology

Clinical Evaluation of Fast-in-Time (FIT) Anti-CD19 CAR T—a Non-Viral, 2-Day Rapid Manufacture CAR T-Cell Therapy for B-Cell Malignancies (SOHO 2024) - "Intervention: Pts underwent apheresis for CAR T manufacturing and began lymphodepleting (LD) chemotherapy (cyclophosphamide 250 mg/m2/day and fludarabine 25 mg/m2/ day) within one day of apheresis. FIT-CD19-CAR-T demonstrates a favorable safety profile and encouraging initial efficacy and PK at relative low doses in patients with heavily pretreated B-cell malignancies, which may be attributable to enhanced expression of naïve and stem cell memory markers on rapidly manufactured FIT-CD19-CAR-T cells. Phase 1 studies are planned for continued investigation."

CAR T-Cell Therapy • Clinical • IO biomarker • Hematological Malignancies • Oncology