Immix Biopharma accelerates enrollment in U.S. AL amyloidosis trial of NXC-201

Immix Biopharma (IMMX) announced 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 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. 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. “We are pleased to report the successful completion of the NEXICART-2 safety run-in segment. Achievement of this milestone positions us to accelerate enrollment in the NEXICART-2 study and brings us one step closer to providing a new treatment option for patients with relapsed/refractory AL Amyloidosis, where no drugs are currently FDA approved,” said Ilya Rachman, MD, PhD, CEO of Immix Biopharma. NXC-201 has been awarded Orphan Drug Designation in AL Amyloidosis by the US FDA and in the EU by the EMA.