LOS ANGELES — September 29, 2026
Immix Biopharma reported interim results from the NEXICART-2 Phase 2 trial of investigational NXC-201 in patients with relapsed/refractory AL amyloidosis, with an 89% complete response rate (40/45 patients) assessed by an independent review committee. Among 25 newly reported patients, 21 had achieved complete response and four were already MRD-negative, resulting in all 25 patients reaching either CR or MRD-negativity. Immix reported that all patients who have achieved MRD-negativity to date subsequently reached CR within one year of treatment. The company said the four MRD-negative patients who have not yet been classified as CR could potentially bring the overall CR rate to 98% (44/45) if those responses mature, although this remains a prospective estimate rather than an observed response rate. No relapses have been reported among patients who achieved CR or MRD-negativity to date.
NEXICART-2 Shows High Complete Response Rate
NEXICART-2 is a 45-patient, multicenter U.S. Phase 2 study evaluating NXC-201 in relapsed/refractory AL amyloidosis. The trial has a potentially registrational design and is assessing a sterically optimized BCMA-targeted CAR-T cell therapy intended to eliminate the plasma cells responsible for producing pathogenic light chains. Across all 45 patients, Immix reported an 89% CR rate based on independent review committee assessment. Among the 25 newly reported patients, 100% were either in CR or MRD-negative. The company also reported that no relapses had occurred among patients who had achieved CR or MRD-negativity at the interim analysis. These findings remain interim results from a relatively small, single-arm clinical program and require continued follow-up to establish the durability and consistency of responses.
MRD-Negativity May Precede Complete Response
The interim analysis also highlighted the relationship between bone-marrow MRD-negativity and subsequent complete response. Immix reported that all patients who had achieved MRD-negativity to date subsequently reached CR within one year of treatment. Four of the 45 patients were reported as MRD-negative but had not yet been classified as CR, leading the company to project that the eventual CR rate could reach 98% if those responses mature. MRD status can provide a deeper measure of disease response than conventional clinical assessments, but the four pending responses remain unconfirmed as complete responses at this interim time point. The company also reported that no neurotoxicity or enterocolitis had been observed to date, while continued safety follow-up will be necessary as the NEXICART-2 population matures.
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NXC-201 Advances Toward 2027 BLA Submission
Immix plans to complete the NEXICART-2 program with a final readout and potential Biologics License Application submission in 2027. NXC-201 is a BCMA-targeted CAR-T therapy incorporating a proprietary CD3ζ, CD8 hinge and binder design that the company describes as a “digital filter” intended to reduce nonspecific activation. The program has received FDA Breakthrough Therapy and Regenerative Medicine Advanced Therapy designations, as well as Orphan Drug designations from the FDA and European Medicines Agency. AL amyloidosis is a plasma-cell disorder in which abnormal light-chain production can lead to amyloid deposition and organ dysfunction. NXC-201 remains investigational, and the reported response rates, durability and safety profile will require additional follow-up and regulatory review before any conclusions regarding approval or comparative clinical benefit can be established.
Source :Immix Biopharma press release
