Immix Biopharma, Inc. (Nasdaq: IMMX) is extending its clinical trial reach for NEXICART-2, a U.S. based study evaluating CAR-T cell therapy NXC-201 in patients with relapsed/refractory AL Amyloidosis. The company announced the addition of Cleveland Clinic, UC Davis, and Sutter Health as new clinical trial sites, joining the lead site Memorial Sloan Kettering Cancer Center (MSKCC). This expansion aims to improve patient access to this novel therapy across the United States.
The NEXICART-2 trial (NCT06097832) is an open-label, single-arm, multi-site Phase 1b/2 dose expansion study. It is designed to assess the safety and efficacy of NXC-201 in patients with relapsed/refractory AL Amyloidosis who have not been previously treated with BCMA-targeted therapies. The trial intends to enroll 40 patients with adequate cardiac function.
Promising Results from NEXICART-1
The NEXICART-2 trial builds upon encouraging data from the ex-U.S. NEXICART-1 study. Results presented at the 27th Annual Meeting of The American Society of Gene and Cell Therapy (ASGCT 2024) showed a 92% overall response rate (12 out of 13 patients) in relapsed/refractory AL Amyloidosis patients. Notably, the best responder experienced a 28-month duration of response, as reported on May 10, 2024.
NXC-201: A Novel CAR-T Therapy
NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy. It is currently the only CAR-T therapy in development for AL Amyloidosis, as highlighted in a June 2024 review article in the New England Journal of Medicine titled "Systemic Light Chain Amyloidosis."
Trial Design and Endpoints
The NEXICART-2 trial will evaluate two dose levels of NXC-201 (150 million and 450 million CAR+ T cells) in a standard 6-patient safety run-in. There is potential for further dose escalation to 800 million CAR+ T cells, a dose level that has shown complete responses in the NEXICART-1 study. The primary endpoints of the NEXICART-2 trial are complete response rate and overall response rate, based on consensus recommendations (Palladini et al. 2012).
Leadership Perspective
"In our mission to advance treatment options for relapsed/refractory AL Amyloidosis patients, we are proud to expand our NEXICART-2 clinical trial footprint to a national scale with the addition of these world-class sites and exceptional principal investigators," said Ilya Rachman, M.D., Ph.D., Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, "Working with our outstanding team and partners, these additional sites support upcoming interim and final read-outs of NEXICART-2."
