Immix Biopharma's subsidiary, Nexcella, is on track to commence dosing patients in the United States with its CAR-T therapy, NXC-201, for relapsed/refractory AL Amyloidosis in mid-2024. This development marks a crucial step forward in providing alternative treatments for patients with this rare and life-threatening disease, for which there are currently no FDA-approved drugs.
NEXICART-2 Trial Details
The NEXICART-2 trial (NCT06097832) is an open-label, single-arm, multi-site Phase 1b dose expansion clinical trial designed to evaluate the safety and efficacy of NXC-201 in patients with relapsed/refractory AL Amyloidosis. The trial aims to enroll 40 patients with adequate cardiac function over approximately 18 months from the first patient being dosed. The primary endpoints of the study are the complete response rate and overall response rate, adhering to consensus recommendations.
NXC-201: A Novel CAR-T Therapy
NXC-201, formerly known as HBI0101, is a BCMA-targeted CAR-T cell therapy uniquely designed to target AL Amyloidosis and other autoimmune diseases. Immix Biopharma believes NXC-201 is the only “Single-Day CRS” CAR-T, potentially allowing for a faster patient discharge due to a median Cytokine Release Syndrome (CRS) onset on day 1 with a median duration of 1 day. The therapy is currently being studied in a comprehensive clinical development program, building on a clinical dataset initiated in February 2021.
Leadership Perspective
"We are on track to dose relapsed/refractory AL Amyloidosis NXC-201 patients at our New York City lead site and other leading U.S. sites in mid-2024. U.S. site clinical trial agreements have been signed, and site initiation visits are being scheduled," said Ilya Rachman, MD PhD CEO of Immix Biopharma and Executive Chairman of Nexcella. He further emphasized the company's commitment to providing additional treatment alternatives for relapsed/refractory AL Amyloidosis patients, highlighting the focus on patients with adequate cardiac function who are most likely to benefit from NXC-201.
Strategic Partnerships
Memorial Sloan Kettering Cancer Center has been announced as the lead clinical site for the NXC-201 clinical trial. Dr. Heather Landau, Memorial Sloan Kettering Cancer Center Amyloidosis Program Director, stated, "NXC-201 represents a novel direction in the treatment landscape for relapsed or refractory AL Amyloidosis patients."
Regulatory Status
NXC-201 has been granted Orphan Drug Designation (ODD) by the FDA for both AL Amyloidosis and multiple myeloma, as well as ODD by the European Medicines Agency (EMA) for AL Amyloidosis, underscoring its potential to address unmet needs in these rare disease populations.
