Commentary|Videos|June 4, 2025
Shahzad Raza, MD, on Evaluating CAR-T NXC-201 in R/R Light Chain Amyloidosis
Author(s)Shahzad Raza, MD
Noah Stansfield
Noah Stansfield
The hematologist/oncologist at the Cleveland Clinic discussed early results from a clinical trial evaluating the BCMA-directed CAR-T therapy.
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“So far, the data is quite promising to share that this is very safe... I'm hoping that by the next 6 months, we will have much more mature data, more patients enrolled... The phase 1b and phase 2a is quite exciting. This data does show it's a safe drug and can be given safely to the patients.”
Relapsed/refractory (r/r) light chain (AL) amyloidosis remains a particularly difficult disease to treat, and as such great unmet need exists for patients in this population. One potential new treatment option currently in development is Immix Biopharma and its subsidiary Nexcella's NXC-201, an investigational autologous BCMA-directed chimeric antigen receptor T-cell (CAR-T) therapy, which is currently being evaluated in the phase 1b/2 NEXICART-2 clinical trial (NCT06097832) in the United States.
Notably, early data from this clinical trial were recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting , held May 30 to June 3, in Chicago, Illinois. During the conference, CGTLive®’s sister site, OncLive®, interviewed Shahzad Raza, MD, a hematologist/oncologist at the Cleveland Clinic who coauthored the study presented at ASCO, to learn more.
In the interview, Raza explained the background context behind the study and went over the key efficacy and safety results presented at the meeting. He explained that the data presented at ASCO included 7 patients treated with NXC-201 and that the results showed high response rates, with some achieving minimal residual disease negativity by day 25. Although, he pointed out that renal and cardiac organ responses are still being evaluated and more mature data will be needed to evaluate these. With regard to safety, Raza noted that cytokine release syndrome (CRS) and neutropenia have been observed, although these are expected with CAR-T therapies. Although, emphasized that no neurotoxicity has been reported, and characterized the early safety data as exciting.
REFERENCE
1. Landau H. Safety and efficacy data from Nexicart-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201. Presented at the 2025 ASCO Annual Meeting, held May 30 to June 3, in Chicago, Illinois. Abstract #7508
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