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Immix Biopharma Doses First US Amyloidosis Patient in CAR T-Cell Therapy Trial

NEW YORK – Immix Biopharma on Monday said the first US patient with amyloid light-chain (AL) amyloidosis has received NXC-201, an autologous CAR T-cell therapy, within a Phase Ib/II clinical trial.

The patient was treated with the B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy at Memorial Sloan Kettering Cancer Center in New York City, the lead site testing NXC-201 in the open-label, dose-expansion NEXICART-2 trial. Immix expects to enroll about 40 patients with relapsed or refractory AL amyloidosis, a condition in which abnormal plasma cells in the bone marrow produce misfolded amyloid proteins that damage organs, including the heart. To qualify for the trial, patients must have adequate cardiac function and cannot have received BCMA-targeted therapy previously.

The Los Angeles-based biopharma company has tested the activity of NXC-201 in a separate Phase Ib/IIa trial, NEXICART-1, outside of the US, in which 12 out of 13 patients responded to the cell therapy.

Immix Biopharma subsidiary Nexcella licensed NXC-201, previously known as HBI0101, from Hadassah Medical Organization in Israel in 2022. The company is also developing NXC-201 in multiple myeloma.