allogeneic CAR-T therapy / EdiGene, Beijing Imunopharm - LARVOL DELTA

Glycan shielding enables TCR-sufficient allogeneic CAR-T therapy. (PubMed, Cell) - P1/2 | "In a phase I clinical trial, SPPL3-null, T cell receptor (TCR)-deficient anti-CD19 allogeneic CAR-T cells reached the safety primary endpoint, with grade 3 or higher cytokine release syndrome (CRS) observed in 3 out of 9 patients with relapsed/refractory B cell non-Hodgkin lymphoma (B-NHL) (ClinicalTrials.gov: NCT06014073). We therefore evaluated the safety of SPPL3-null, TCR-sufficient CAR-T therapy on three patients with lymphoma or leukemia for compassionate care and observed no clinical signs of graft-versus-host disease. Our findings suggest glycan shielding by SPPL3 deletion is a promising direction for optimizing universal CAR-T therapies."

Journal • B Cell Non-Hodgkin Lymphoma • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Glycan Shielding via Single SPPL3 Ablation Enables TCR-Sufficient Long-Lasting Allogeneic CAR-T Therapy in Patients (ASGCT 2025) - P1/2 | "The 3+3 dose escalation design includes lymphodepletion with fludarabine (30-50 mg/m²/d) and cyclophosphamide (500-1000 mg/m²/d) for three days (day-5 to -3), followed by escalating doses of ET-901-Athena (1×10⁶/kg, 3×10⁶/kg, 10×10⁶/kg) or ET-901-Herculas (1×10⁶/kg, 3×10⁶/kg, 6×10⁶/kg). Glycan-shielded allogeneic CAR-T cells can persist for over six months, control tumors, resist immune rejection, and avoid GvHD. These findings position SPPL3 engineering as a transformative platform for universal CAR-T therapies."

Clinical • Late-breaking abstract • Dermatology • Graft versus Host Disease • Immunology • Oncology

Changes in Glycosylation on the Cell Surface Result in Highly Potent and Long-Lasting Allogeneic CAR-T Therapy in Patients (ASH 2024) - "Following lymphodepletion of fludarabine (30-50 mg/m2/d) and cyclophosphamide (500-1000 mg/m2/d) for a duration of 3 days, patients receive a single-dose infusion of ET-901 at escalating doses of 1*10e6/kg, 3*10e6/kg, and 10*10e6/kg. All patients demonstrated objective responses, with significant CAR-T cell expansion, confirming the engineered cells' long-term immune privilege and activity. This represents a significant step in making allogeneic CAR T-cell therapy more viable and effective."

Clinical • Anemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Thrombocytopenia • B2M

Changes in Glycosylation on the Cell Surface Result in Highly Potent and Long-Lasting Allogeneic CAR-T Therapy in Patients (ASGCT 2024) - P1/2 | "An ongoing clinical trial (NCT06014073) with these allogeneic CAR T-cell demonstrated high anti-tumor activity and persistence for more than 3 months in first 5 evaluable R/R NHL patients (Data cut-off date is January 20, 2024), with 100% ORR and 60% CR and manageable safety profile. Our research highlights the complex immune interactions and positions GeneX engineering as a promising strategy for creating universal therapeutic cells."

Clinical • Graft versus Host Disease • Hematological Malignancies • Immunology • Oncology • Transplant Rejection • B2M