Core Insights - Immix Biopharma has expanded its clinical trial sites for the NEXICART-2 study, which focuses on CAR-T NXC-201 for relapsed/refractory AL Amyloidosis, enhancing patient access across the U.S. [1][3] - The NEXICART-2 study aims to evaluate the safety and efficacy of CAR-T NXC-201, building on positive results from the previous NEXICART-1 study, which reported a 92% overall response rate [2][4] - NXC-201 is the only CAR-T therapy currently in development for AL Amyloidosis, with no reported neurotoxicity, and has received Orphan Drug Designation from the FDA and EMA [3][7] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and immune-mediated diseases [10] - The company’s lead candidate, NXC-201, is undergoing evaluation in both U.S. and ex-U.S. clinical trials, with promising initial data supporting its safety profile [6][10] Clinical Trial Details - The NEXICART-2 trial is a Phase 1b/2 study designed to enroll 40 patients with adequate cardiac function who have not received prior BCMA-targeted therapy [4] - The trial will evaluate two doses of CAR-T NXC-201, with potential escalation to higher doses based on safety and efficacy outcomes [4] Market Insights - The prevalence of relapsed/refractory AL Amyloidosis in the U.S. is estimated to grow at 12% annually, reaching approximately 33,277 patients in 2024 [9] - The AL Amyloidosis market was valued at 6 billion by 2025 [9]
Immix Biopharma Expands U.S. Clinical Sites for relapsed/refractory AL Amyloidosis Trial NEXICART-2