Core Insights - Immix Biopharma has successfully completed the six-patient Phase 1b safety run-in segment of the NEXICART-2 study for NXC-201, a CAR-T therapy targeting relapsed/refractory AL Amyloidosis, which is expected to accelerate patient enrollment starting January 2025 [1][3][5] Company Overview - Immix Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing cell therapies for AL Amyloidosis and select immune-mediated diseases [10] - The lead candidate, NXC-201, is a BCMA-targeted CAR-T cell therapy that has shown promising results in initial studies, including high complete response rates and no neurotoxicity [4][10] Clinical Study Details - The NEXICART-2 study is an open-label, single-arm, multi-site Phase 1b/2 clinical trial designed to evaluate the safety and efficacy of NXC-201 in patients with relapsed/refractory AL Amyloidosis [6] - The study consists of a safety run-in segment with six patients, followed by a 34-patient dose expansion segment, with two dosing levels evaluated [2][6] Market Context - AL Amyloidosis affects approximately 33,000 patients in the U.S., with no FDA-approved therapies currently available for relapsed/refractory cases [7][9] - The amyloidosis market was valued at 6 billion by 2025, indicating significant growth potential [9]
Immix Biopharma Accelerates Enrollment in U.S. AL Amyloidosis Trial of NXC-201 CAR-T