Immix Biopharma, Inc. (Nasdaq: IMMX) announced on September 29, 2026, that its lead candidate, NXC-201, achieved an 89% complete response (CR) rate across all 45 patients enrolled in the Phase 2 NEXICART-2 clinical trial. The results were assessed by an independent review committee.
The trial, a multi-site U.S. study with a registrational design, focuses on patients with relapsed/refractory AL Amyloidosis. According to the filing, all 25 newly enrolled patients in the trial are either in CR or have achieved minimum residual disease (MRD)-negativity. Of these new patients, 21 are in CR and the remaining 4 are MRD-negative.
The company noted that all patients who have achieved MRD-negativity have reached a CR within one year of treatment. Additionally, four patients who are currently MRD-negative are predicted to reach CR, which could potentially increase the overall CR rate to 98% (44/45 patients). No relapses have been observed to date for patients who reached CR or MRD-negativity.
Safety data through August 4, 2026, was reported as consistent with previous findings. No neurotoxicity or enterocolitis has been observed to date. The NEXICART-2 trial is fully enrolled, and the company plans to submit a Biologics License Application (BLA) in mid-2027.
NXC-201 is a sterically-optimized CAR-T cell therapy targeting BCMA. The candidate has been awarded Breakthrough Therapy Designation (BTD) and Regenerative Medicine Advanced Therapy (RMAT) designation by the U.S. FDA, as well as Orphan Drug Designation (ODD) by the FDA and the EMA.
