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Clinical trial Phase 3 Interventional Ages 18 and up

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

Run by Nexcella Inc. · NCT07709715 · Data updated 2026-11-12

Not yet open. This study is not taking new participants. Its registered completion date is 2028-12.

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.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment260 (estimated)
SponsorNexcella Inc.
Industry-sponsored
Drugs / interventionsNXC-201, Dara-CyBorD
Trial IDNCT07709715 on ClinicalTrials.gov

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.