Immix Biopharma has completed the safety run-in portion of its U.S. Phase 1b NEXICART-2 study for NXC-201, a CAR-T therapy for relapsed/refractory AL Amyloidosis. This achievement allows the company to accelerate enrollment in the broader study, focusing on a 450 million CAR-T cell dose. NXC-201 is notably the only CAR-T therapy currently in development for this life-threatening disease, which affects approximately 33,000 patients in the U.S. and currently has no FDA-approved treatments.
This successful safety run-in is a critical step towards potentially bringing a much-needed treatment option to patients battling AL Amyloidosis. The positive safety data in this trial, combined with previous complete response observations from an earlier ex-U.S. study, strengthens the therapy’s potential to address the unmet medical need in this patient population. The acceleration of enrollment in the U.S. trial will be crucial in building the clinical data necessary for potential regulatory approval, which could significantly impact patient outcomes and offer hope where currently there are limited options.
The NEXICART-2 study involves two segments: a completed six-patient safety run-in and a 34-patient dose expansion segment. The safety run-in included two dose levels (150 million and 450 million CAR-T cells), both of which have previously shown complete responses in an earlier study. With the successful completion of the safety evaluation for all six patients, the study can now proceed with the 450 million CAR-T cell dose. The next program update is expected in Q1 2025.
The positive results from the safety run-in, coupled with the accelerated enrollment, positions Immix Biopharma well in the race to develop an effective treatment for AL Amyloidosis. This progress reinforces the potential of NXC-201 to become a game-changer in this area, offering a new and possibly life-saving therapeutic option for patients. The upcoming program updates in Q1 2025 will be highly anticipated and could be a significant catalyst for the company and the AL Amyloidosis treatment landscape.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
