Immix reports an 89% complete response rate with NXC-201 in the interim NEXICART-2 trial in relapsed/refractory AL amyloidosis.
Written By: Aasritha Thippavajjala, PharmD
Reviewed By: Pharmacally Editorial Team
Immix Biopharma has reported interim clinical findings from NEXICART-2, a U.S. multicenter study evaluating its investigational BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy NXC-201 in patients with relapsed or refractory light-chain (AL) amyloidosis.
Across all 45 patients included in the interim update, 40 achieved complete response (CR), representing 88.9% of the population. The company reported the result as an 89% CR rate based on assessment by an independent review committee. The findings were announced on September 29, 2026.
NEXICART-2 Evaluates NXC-201 in Relapsed/Refractory AL Amyloidosis
NEXICART-2 (NCT06097832) originally registered as a Phase 1b/2 study, Immix now describes NEXICART-2 as a 45-patient, multicenter U.S. Phase 2 trial with a registrational design. This distinction reflects the way the company currently characterizes the study compared with its earlier registered description.
NXC-201 is an investigational, sterically optimized BCMA-targeted CAR-T cell therapy designed by Immix to target plasma cells producing abnormal light chains.
The September 2026 update does not provide detailed information on the lymphodepletion regimen, dosing schedule, response-assessment criteria or duration of follow-up for the 45-patient interim population.
25 Newly Reported Patients Show CR or MRD-Negative Status
The company also reported outcomes from 25 newly reported patients. All 25 patients had either achieved CR or were minimal residual disease (MRD)-negative.
Among these patients, 21 of 25 (84%) achieved CR, while the remaining four patients (16%) were MRD-negative but had not yet reached CR. Immix reported that all patients who achieved MRD negativity subsequently reached CR within one year.
The company also reported that no relapses had been observed to date among patients who had achieved CR or MRD negativity. However, the interim announcement does not provide sufficient follow-up or time-to-event data to establish the durability of these responses.
MRD Negativity Could Increase Future CR Rate
The four patients who were MRD-negative but had not yet achieved CR form the basis for the company’s projection that the eventual CR rate could reach up to 98% (44 of 45 patients; 97.8%).
This 98% figure should not be interpreted as an observed CR rate. It represents a potential future outcome based on the company’s statement that bone-marrow MRD negativity predicts subsequent CR. Longer follow-up will be required to determine whether these patients subsequently achieve complete response.
The distinction is important because the currently observed trial-wide CR rate remains 40 of 45 patients, or 88.9%.
Limited Safety Findings Reported in Interim Update
Immix reported that no neurotoxicity or enterocolitis had been observed to date in the NEXICART-2 population.
The September 2026 announcement does not provide a comprehensive safety dataset covering cytokine release syndrome, treatment-emergent adverse events, serious adverse events, grade 3 or 4 toxicities, dose-limiting toxicities, treatment discontinuations or deaths. Therefore, the available safety information should be considered limited to the findings specifically disclosed in this interim update.
FDA Designations and Planned BLA Submission
NXC-201 has received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA. The therapy has also received Orphan Drug Designation from the FDA and the European Medicines Agency (EMA).
Immix plans to provide a final NEXICART-2 readout and submit a Biologics License Application (BLA) in mid-2027.
The company has characterized NXC-201 as having potential to become a best-in-class therapy. This remains a company characterization, and NXC-201 is still investigational. Its safety and efficacy have not been established by the FDA or another regulatory authority.
What the Interim Data Show
The NEXICART-2 interim update provides an observed 88.9% complete response rate among 45 patients, with an additional four patients reported as MRD-negative but not yet in CR.
The findings provide an early efficacy signal for NXC-201 in relapsed/refractory AL amyloidosis. However, the interim nature of the analysis, limited follow-up information and absence of a comprehensive safety dataset leave important questions regarding response durability and the broader safety profile.
Further follow-up and the planned final NEXICART-2 analysis will be needed to determine whether the four MRD-negative patients convert to CR and whether the reported responses remain durable.
Reference
Immix Biopharma Announces 89% Complete Response Rate at Interim Update Across All NEXICART-2 Patients, with MRD-Negativity Indicating Potential to Reach up to 98% Complete Response Rate, Supporting Potential Best-in-Class Therapy for Relapsed/Refractory AL Amyloidosis, IMMIX Biopharma, 29 September 2026
Study of NXC-201 CAR-T in Patients with Light Chain (AL) Amyloidosis (NEXICART-2), ClinicalTrials.gov ID NCT06097832
About the Writer
Aasritha Thippavajjala (Linkedin) is a pharm D student and aspiring medical writer with medical writing, clinical training experience and a strong interest in clinical research and patient safety She has hands-on exposure to clinical pharmacy activities including medication profile assessment, clinical case review, identification of potential drug-related problems, ADR awareness, patient counselling, and clinical documentation. She has also gained experience in medical literature review, evidence synthesis, and scientific communication through her published review article on digital twin-based patient simulation and her poster presentation at the 74th Indian Pharmaceutical Congress. Certified in ICH Good Clinical Practice (E6(R3)) and Scientific Writing in Health Research, she is passionate about applying her clinical knowledge and research skills to medical writing ,clinical research and contributing to accurate, evidence-based healthcare.