NCT07709715Not yet recruitingPhase 3
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]
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 12 Jul 2026
- Start date
- Jan 2027
- Primary completion date
- Dec 2028
- Lead sponsor
- Nexcella Inc.
- Diseases
- Amyloidosis
- NCT number
- NCT07709715
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 260
- From Jan 2027 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy for AL amyloidosis or multiple myeloma
Other illness
- Cardiac stage IIIb patients
- History of malignancy (other than AL amyloidosis) within 3 years
- Stroke or seizure within 6 months of signing ICF
- NOTE: Other protocol defined inclusion/exclusion criteria apply
Other
- Diagnosis of multiple myeloma
Who the study is looking for
- Eastern Cooperative Oncology Group performance status score ≤2
- Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol
- Measurable disease as defined in the protocol
- One or more organs impacted by AL amyloidosis
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.