Immix Biopharma, along with its subsidiary Nexcella, has announced the progression of its Phase 1b/2 NEXICART-2 clinical trial for NXC-201, an autologous CAR-T therapy, into the expansion cohort. This trial is evaluating NXC-201 for the treatment of relapsed/refractory light chain (AL) amyloidosis. The advancement follows the completion of dosing in the initial cohort, marking a significant step forward in the development of a new treatment option for this challenging disease.
Trial Design and Dosage
The initial cohort of the NEXICART-2 study involved treating three patients with a dose of 150 million CAR+ T cells. The expansion cohort will utilize a higher dose of 450 million CAR+ T cells. Dosing in the expansion cohort will be staggered, with one patient being dosed every 28 days initially, after which multiple patients per month will be eligible for dosing. This study is the first to evaluate NXC-201 in the United States, complementing the ongoing Phase 1a/1b NEXICART-1 clinical trial in Israel.
Management Commentary
"We are pleased to report that the NEXICART-2 study is making excellent progress," stated Ilya Rachman, MD, PhD, CEO of Immix Biopharma. "We are now one step closer to providing a new treatment option for patients with r/r AL Amyloidosis, where no FDA drugs are approved today. Robust enrollment reflects the enthusiasm of clinical investigators for CAR-T NXC-201."
Clinical Data from NEXICART-1
Immix Biopharma previously presented data from the NEXICART-1 trial at the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting. As of the data cutoff, 13 patients with AL amyloidosis had been treated with NXC-201 at varying doses. The overall hematological response rate was 92% (12 out of 13 patients), with 69% (9 out of 13 patients) achieving a complete hematological response.
NXC-201: A Novel BCMA-Targeted CAR-T Therapy
NXC-201 is a BCMA-targeted CAR-T cell therapy. The US IND clearance for NXC-201 in November 2023 was preceded by a pre-IND meeting with the FDA in June and the completion of the first engineering batch for NXC-201 in the US in July. The FDA has granted orphan drug designation to NXC-201 for both multiple myeloma and AL amyloidosis.
About AL Amyloidosis
AL amyloidosis is a rare plasma cell disorder characterized by the overproduction of light chains, which misfold and deposit as amyloid fibrils in various organs, leading to organ damage and failure. The estimated prevalence of relapsed/refractory AL Amyloidosis in the U.S. is approximately 33,000 patients in 2024, with the market expected to reach $6 billion by 2025.
