NXC-201 (HBI10101) - (NEXICART-2)

May 21, 2026: Immix Biopharma, Inc. (NASDAQ: IMMX) reported updated Phase 2 NEXICART-2 (NCT06097832) results for its BCMA-targeted CAR-T NXC-201 in relapsed/refractory AL amyloidosis. The company said all four MRD-negative patients previously presented at ASH 2025 have converted to complete response (CR). Overall, the CR rate is now 95% (19/20 patients), with all CRs reached within 1 year post-dosing, and no relapses observed to date among patients who reached CR. The company also stated that all subsequently enrolled patients with available MRD results were MRD-negative at one month.

NEXICART-2 is described as a multi-site U.S. Phase 2 trial with a registrational design and a target enrollment of 45 patients. Based on these results, Immix plans to initiate a multi-center, randomized Phase 3 trial in newly diagnosed AL amyloidosis.

Upcoming catalysts: next NEXICART-2 update expected late September 2026; the company expects to present 1-year follow-up data by end of March 2027, which it says it expects to drive a BLA submission and commercial launch (if approved).