• 8 AL Amyloidosis patients relapsed/refractory to DARZALEX®-based regimens were treated with CAR-T NXC-201
• 100% (8/8) overall response rate and 63% (5/8) complete response (MRD 10^-5) was demonstrated by NXC-201 with zero ICANs, zero grade 4 CRS
• 62% (5/8) had NYHA classification III or IV heart failure prior to treatment with NXC-201
• Best responder duration of response was 16.5 months with response ongoing as of the data cutoff date of May 11, 2023

“We continue to be very encouraged by NXC-201,” said Polina Stepensky, M.D., Director of the Hadassah Medical Organization’s Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. “In AL amyloidosis, these data are compelling as recent trials demonstrate an overall response rate of 55% for DARZALEX-relapsed or refractory AL amyloidosis patients receiving investigator’s choice. Importantly, NXC-201 may offer a valuable option for the increasing number of AL amyloidosis patients who have progressed on DARZALEX-based standards of care.”

Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial