Immix Biopharma, Inc. announced successful completion of the six-patient Phase 1b safety run-in segment in the U.S. NEXICART-2 study of NXC-201, an investigational CAR-T therapy, in patients relapsed/refractory (R/R) AL Amyloidosis. Achievement of this milestone is expected to accelerate enrollment across U.S. study sites beginning in January 2025. NEXICART-2 is an open-label study designed to evaluate NXC-201 in patients with R/R AL Amyloidosis.
The study has two segments: a six-patient ?safety run-in? segment and a 34-patient dose expansion segment. The Phase 1b ?safety run-in?
segment dosed three patients at 150 million CAR-T cells and three patients at 450 million CAR-T cells (these doses also produced complete responses in the prior ex-US NEXICART-1 study). All six patients successfully completed a post-dosing safety evaluation, and enrollment can now proceed across U.S. study sites at 450 million CAR-T cells. NXC-201 is the only CAR-T therapy currently in development in AL Amyloidosis.
