Autolus presents clinical data on TB-guided dosing strategy at SOHO meetin

Autolus Therapeutics announces a poster presentation at the Society of Hematologic Oncology Annual Meeting being held September 4-7, 2024 in Houston, Texas. These data demonstrate the rationale for tumor burden-guided dosing in adult patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia by analyzing the impact of bone marrow blast percentage prior to lymphodepletion in patients treated with obe-cel in the FELIX Phase 1b/2 study. Poster presentation: Title: Obecabtagene autoleucel for Relapsed/Refractory Adult B-Cell Acute Lymphoblastic Leukemia: Impact of Chimeric Antigen Receptor T-Cell and Tumor Burden-Guided Dosing in the FELIX Phase 1b/2 Study. Summary: Tumor burden is a recognized driver of immunotoxicity from CAR T therapy for B-ALL. Obe-cel is a novel autologous CAR T with a differentiated fast off-rate CD19 binding domain and a 4-1BB co-stimulatory domain, designed to improve CAR T persistence and immunotoxicity. Obe-cel is an investigational therapy being evaluated in adult r/r B-ALL in the FELIX Phase Ib/II study, utilizing TB-guided dosing based on bone marrow blast percentage prior to lymphodepletion. We report outcomes by TB, demonstrating the rationale for TB-guided dosing in adult r/r B-ALL. Of 127 patients infused with obe-cel, 120 received the planned two doses. Overall, high CAR T expansion was observed, which progressively increased with TB; a TB increase of 50% was associated with a 1.754-fold increase in Cmax and a 2.068-fold increase in AUC0-28days. In both groups, peak expansion was reached after Dose 2, demonstrating the need for both doses regardless of TB. Overall remission rate was 90% and 75% in low and high TB groups, respectively. In summary, TB-guided dosing was associated with high CAR-T cell expansion and while providing a manageable adverse event profile. This supports the TB guided-dosing approach in adult r/r B-ALL.