The FDA granted orphan drug designation to NXC-201 in AL amyloidosis and multiple myeloma. Credit: S_L / Shutterstock.com.

Immix Biopharma is set to assess its investigational chimeric antigen receptor T (CAR-T) cell therapy, BCMA CAR-T NXC-201 (previously HBI0101), in a Phase Ib/IIa clinical trial underway for treating relapsed/refractory (R/R) AL amyloidosis.

The latest move comes after the company received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application for NXC-201.

Named NEXICART-1, the open-label trial is designed to assess the efficacy and safety of NXC-201 in adult patients with R/R multiple myeloma and R/R AL amyloidosis.

The Phase Ib part of the study has already determined the recommended Phase II dose (RP2D) of 800 million CAR+T cells. 

The overall response rate is the primary endpoint for NXC-201 in relapsed/refractory AL amyloidosis.

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The company intends to submit the findings to the regulator for relapsed/refractory AL amyloidosis dosing in 30-40 subjects.

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A BCMA-targeted CAR-T cell therapy, NXC-201 will be analysed for additional autoimmune indications such as systemic lupus erythematosus, myasthenia gravis, and multiple sclerosis in the future, based on favourable trial data.

Immix Biopharma CEO Ilya Rachman said: “Building on encouraging NXC-201 clinical data to date, we are thrilled that multiple leading US sites are currently planning to enrol patients in the coming months. 

“No approved treatment options currently exist for relapsed/refractory AL Amyloidosis patients.”

The FDA previously granted orphan drug designation to NXC-201 in AL amyloidosis and multiple myeloma.

Immix Biopharma chief financial officer Gabriel Morris said: “We credit our world-class cell-therapy expert team in achieving this IND clearance in line with our previously communicated timelines. 

“NXC-201’s favourable tolerability profile, including overcoming neurotoxicity, potentially enables expansion beyond AL amyloidosis into autoimmune indications.”

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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