A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis

A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of NXC-201 Compared With Daratumumab With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Newly Diagnosed Systemic AL Amyloidosis [NEXICART-3]

The purpose of this study is to evaluate the efficacy and safety of NXC-201 compared with Dara-CyBorD (daratumumab-cyclophosphamide-bortezomib-dexamethasone) in the treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

Key Inclusion Criteria:

1. Eastern Cooperative Oncology Group performance status score ≤2
2. Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol
3. Measurable disease as defined in the protocol
4. One or more organs impacted by AL amyloidosis

Key Exclusion Criteria:

1. Prior therapy for AL amyloidosis or multiple myeloma
2. Diagnosis of multiple myeloma
3. Cardiac stage IIIb patients
4. History of malignancy (other than AL amyloidosis) within 3 years
5. Stroke or seizure within 6 months of signing ICF

NOTE: Other protocol defined inclusion/exclusion criteria apply