Immix Biopharma, Inc. has announced that it has surpassed the 50% enrollment milestone in its ongoing NEXICART-2 clinical trial for relapsed/refractory AL Amyloidosis. The trial involves the use of sterically-optimized CAR-T NXC-201, which is on track for the first FDA Biologics License Application (BLA) approved cell therapy in this orphan indication. The company continues to enroll patients expediently toward BLA submission.
The NEXICART-2 trial is a multi-site U.S. Phase 1/2 clinical trial with a registrational design, expected to enroll 40 patients. NXC-201, the therapy being tested, is a BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a "digital filter" to prevent non-specific activation. It has been awarded Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designation (ODD) by the FDA and EMA.
