Immix Biopharma reports 95% complete response rate in next-gen amyloidosis trial

Immix Biopharma (NASDAQ:IMMX) announced a highly favorable interim update from its ongoing registrational Phase 2 NEXICART-2 clinical trial, showing that its investigational CAR-T cell therapy, NXC-201, achieved a 95% complete response rate in patients with relapsed or refractory AL Amyloidosis.

The clinical update evaluated the initial 20 patients enrolled in the multi-site U.S. trial, a population that had undergone a median of four prior lines of standard therapy.

Data showed that 19 out of the 20 heavily pretreated participants reached a complete hematologic response, with all of those responses achieved within one year of post-dosing follow-up.

Furthermore, no hematologic relapses have been recorded among the responding patients to date.

The B-cell maturation antigen (BCMA)-targeted cell therapy also demonstrated deep responses at the molecular level.

All four patients who had previously achieved minimal residual disease (MRD) negativity converted into full complete responses.

For later-enrolled patients in the study for whom early data is available, all tested MRD-negative at the one-month evaluation benchmark.

AL Amyloidosis is a rare, life-threatening condition in which the immune system overproduces abnormal, misfolded plasma cell light chains that accumulate as toxic deposits in vital organs—including the heart, kidneys, and liver—frequently resulting in organ failure.

There are currently no FDA-approved therapeutic alternatives specifically indicated for the relapsed or refractory setting.

The rapid normalization of toxic light chains without any observed neurotoxicity support corporate plans to expand the clinical pipeline.

Immix announced it intends to initiate a separate multi-center, randomized Phase 3 trial evaluating NXC-201 as a frontline, potential "one-and-done" treatment for newly diagnosed AL Amyloidosis patients.

Management expects to present the next comprehensive data update from the ongoing 45-patient NEXICART-2 cohort in late September 2026.

Full one-year follow-up statistics across the entire study group are targeted for release by the end of March 2027, which executive leadership plans to use to support a subsequent Biologics License Application (BLA) submission and commercial launch strategy.