Immix Biopharma Surpasses 50% Enrollment In NEXICART-2 AL Amyloidosis Trial Of NXC-201

Immix Biopharma, Inc., a clinical-stage biopharmaceutical company focused on advancing cell therapies for AL Amyloidosis and other serious conditions, announced that it has surpassed the 50% enrollment milestone in its ongoing NEXICART-2 trial. The Phase 1/2 U.S. study is evaluating the sterically-optimized CAR-T therapy NXC-201 in patients with relapsed or refractory AL Amyloidosis, and enrollment continues to progress toward a potential Biologics License Application (BLA) submission.

Gabriel Morris, Chief Financial Officer of Immix Biopharma, said, “Growing excitement accelerates NEXICART-2 BLA submission for FDA approval, and supports future commercial awareness.”

Interim data from NEXICART-2 were shared in an oral presentation at the American Society for Clinical Oncology (ASCO) 2025 annual meeting by Dr. Heather Landau of Memorial Sloan Kettering Cancer Center. The trial (NCT06097832) is designed as a registrational study and aims to enroll a total of 40 patients.

“With excitement generated by our clinical results presented at ASCO, surpassing 50% enrollment in NEXICART-2 demonstrates the growing interest among relapsed/refractory AL Amyloidosis clinicians and patients, where no drugs are FDA approved today,” said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. 

NXC-201 is a BCMA-targeted CAR-T therapy engineered with steric optimization and a unique “digital filter” mechanism to reduce non-specific activation. It has already received both Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug Designation (ODD) from the FDA, as well as ODD from the European Medicines Agency (EMA), highlighting its potential to address significant unmet needs in AL Amyloidosis.