Immix Biopharma Announces FDA IND Clearance For CAR-T NXC-201

(RTTNews) - Immix Biopharma, Inc. (IMMX) on Tuesday announced that the Investigational New Drug (IND) application for BCMA CAR-T NXC-201 (previously known as HBI0101) has been cleared by the FDA.

This clearance allows NEXICART-2 (NCT06097832) to expand studies of NXC-201 in relapsed/refractory AL Amyloidosis to the United States, which is a significant step forward in the fight against this rare disease.

Furthermore, the favorable tolerability of NXC-201 means that there is potential for expansion into autoimmune indications, which could have even broader implications for the treatment of other diseases.

Meanwhile, NEXICART-1 (NCT04720313) is an ongoing Phase 1b/2a, open-label study that is evaluating the safety and efficacy of NXC-201 in adults with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis.

The company plans to submit data to the FDA in relapsed/refractory AL amyloidosis once 30-40 patients have been treated with NXC-201.