Nexcella, a subsidiary of Immix Biopharma, is set to present updated clinical data on its NXC-201 CAR-T therapy for relapsed/refractory multiple myeloma at the 20th International Myeloma Society Annual Meeting in Athens, Greece, from September 27-30, 2023. The data highlights the potential of NXC-201, a BCMA-targeted CAR-T cell therapy, in treating patients with multiple myeloma and AL amyloidosis who have exhausted other treatment options.
NEXICART-1 Trial Overview
The ongoing Phase 1b/2a NEXICART-1 trial (NCT04720313) is evaluating the safety and efficacy of NXC-201 in adult patients with relapsed/refractory multiple myeloma and relapsed/refractory AL amyloidosis. The Phase 1b portion of the study successfully determined the recommended Phase 2 dose (RP2D) of 800 million CAR+ T cells. The Phase 2 portion is designed to assess the efficacy and safety of NXC-201 in these patient populations, using the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma and consensus recommendations for AL amyloidosis.
Clinical Data and Future Plans
Nexcella aims to submit an Investigational New Drug (IND) application to the FDA to expand the clinical trial to the U.S., initiating a Phase 1b/2 study of NXC-201 in relapsed/refractory multiple myeloma and AL amyloidosis. The primary endpoint for the Phase 2 portion of the trial in multiple myeloma is overall response rate and duration of response. The company plans to submit data to the FDA after treating 100 patients with multiple myeloma and 30-40 patients with AL amyloidosis.
NXC-201: A Novel BCMA-Targeted CAR-T Therapy
NXC-201 (formerly HBI0101) is an investigational CAR-T cell therapy targeting B-cell maturation antigen (BCMA). It is currently under clinical development for patients with relapsed or refractory multiple myeloma and AL amyloidosis. Preclinical and early clinical data suggest that NXC-201 could offer a significant benefit to patients who have relapsed after or are refractory to standard treatments.
Multiple Myeloma: An Unmet Need
Multiple myeloma is an incurable blood cancer characterized by the excessive proliferation of plasma cells in the bone marrow. Despite advancements in treatment, most patients eventually relapse. In the United States, approximately 35,730 individuals are diagnosed with multiple myeloma each year. The prognosis for patients who do not respond to or relapse after treatment with standard therapies remains poor, highlighting the urgent need for novel therapeutic options.
Expert Commentary
Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and NXC-201 principal study investigator, stated, “We are pleased to present clinical data in relapsed multiple myeloma at the upcoming International Myeloma Society Annual Meeting, an important international forum for discussion of novel treatments for multiple myeloma and AL Amyloidosis.”
