First 23-Patient Safety and Efficacy Data from Nexicart-2, the First U.S. Trial of CAR-T in R/R Light Chain (AL) Amyloidosis, Nxc-201

No FDA approved drugs exist for relapsed/refractory (RR) AL Amyloidosis. CAR-T is
a novel approach. We report safety and efficacy from the first 23 pts in NEXICART-2,
the first U.S. clinical trial of any CAR-T in RR AL Amyloidosis.NEXICART-2 (NCT06097832)
is a single-arm, multi-site U.S. Phase 1/2 trial of autologous BCMA-targeted CAR-T
NXC-201 in RR AL Amyloidosis. It will enroll 40 pts. Pts have been exposed to bortezomib
and anti-CD-38 antibody with persistent or relapsed disease with measurable disease
(dFLC >5mg/dl or dFLC >2mg/dl with abnormal k:l ratio, or M-spike >0.5g/dl).

ASH 2023 | Safety and efficacy of NXC-201, an anti-BCMA CAR-T, in R/R AL amyloidosis

Vaishali Sanchorawala, MD, Boston University School of Medicine, Boston, MA, discusses findings from a Phase I/II trial (NCT04720313) investigating NXC-201, an anti-BCMA CAR-T product, in the treatment of heavily pretreated relapsed/refractory (R/R) light chain (AL) amyloidosis. The trial found a 100% hematologic response (HR) rate, with 70% being hematologic complete responses (hemCR). In terms of safety, cytokine release syndrome (CRS) was common but low-grade, and there was no neurotoxicity. This interview took place at the 65th ASH Annual Meeting and Exposition, held in San Diego, CA.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

ASH 2025 | Initial results from the NEXICART-2 trial of BCMA-directed CAR-T (NXC-201) in R/R AL amyloidosis

maxresdefault

Heather Landau, MD, Memorial Sloan Kettering Cancer Center, New York, NY, discusses data from the first 20 patients treated in the NEXICART-2 trial (NCT06097832), a Phase I/II dose escalation and expansion study of the BCMA-directed CAR T-cell therapy NXC-201 in patients with relapsed/refractory (R/R) light chain (AL) amyloidosis. Dr Landau suggests that this CAR-T construct may potentially address a significant unmet clinical need, as she notes that no FDA-approved therapies exist in this patient population. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.

These works are owned by Magdalen Medical Publishing (MMP) and are protected by copyright laws and treaties around the world. All rights are reserved.

Tanya Tucker

Tanya Tucker

Tanya Tucker is among the first patients in the U.S. to receive CAR T-cell therapy in a clinical trial for relapsed or refractory AL amyloidosis.