Immix Biopharma’s subsidiary Nexcella announced new positive clinical data from its ongoing Phase 1b/2 NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory light chain amyloidosis and multiple myeloma. NXC-201 clinical data showed the following: in Multiple Myeloma, 92% was the overall response rate produced by NXC-201 in relapsed/refractory multiple myeloma patients treated at the therapeutic dose of 800 million CAR+T cells in its ongoing phase 1b/2a NEXICART-1 clinical trial, producing a median progression free survival (mPFS) of 12.3 months. 87% overall response rate was observed in relapsed/refractory multiple myeloma. The expected primary endpoint for NXC-201 in relapsed/refractory multiple myeloma is overall response rate and duration of response Additionally, favorable NXC-201 safety data support investigating NXC-201 as the first potential outpatient CAR-T cell therapy, potentially reducing NXC-201 CAR-T-related hospitalization costs by up to 80%. Nexcella plans to submit for FDA approval in multiple myeloma once 100 patients are treated with NXC-201. In AL Amyloidosis, a 100% overall response rate, 71% organ response rate, 63% complete hematologic response rate for NXC-201 in 8 relapsed/refractory AL Amyloidosis patients in our ongoing phase 1b/2a NEXICART-1 clinical trial. Nexcella plans to submit for FDA approval in AL amyloidosis once 30-40 patients are treated with NXC-201.
Published first on TheFly
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