ClinicalTrials.gov record NCT07709715

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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]

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.

Age18 years old and older

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized Phase 3 study compares NXC-201, a BCMA-targeted CAR‑T cell therapy, with daratumumab plus cyclophosphamide, bortezomib and dexamethasone (Dara‑CyBorD) in people with newly diagnosed systemic light‑chain (AL) amyloidosis. The trial will evaluate measures of blood (hematologic) response and organ outcomes over defined follow-up periods. It is an unmasked, two‑arm study that assesses both effectiveness and safety.

What it is studying. The study is testing the efficacy and safety of NXC-201 compared with daratumumab plus CyBorD in people with newly diagnosed systemic AL amyloidosis. Main outcomes include overall complete hematologic response measured by consensus criteria and major organ deterioration–progression‑free survival.

What the researchers hope to learn. To compare NXC-201 and Dara‑CyBorD for overall complete hematologic response rate and for major organ deterioration progression‑free survival, and to assess safety outcomes in newly diagnosed AL amyloidosis.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Dara-CyBorD
Biological: NXC-201

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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
Key

Exclusion criteria

Prior therapy for AL amyloidosis or multiple myeloma
Diagnosis of multiple myeloma
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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

If eligible, you would be randomized to receive either NXC‑201 (an investigational autologous CAR‑T cell therapy) or daratumumab plus CyBorD (a drug combination). Participation involves receiving the assigned treatment, regular clinic visits with medical exams, blood tests and other assessments to track disease and organ function, and monitoring for side effects. Follow‑up and outcome assessments are planned through timelines that include evaluations up to 60 months.

How the study is structured. A randomized, unmasked Phase 3 trial with two parallel arms. Participants are assigned to receive either NXC-201 (an autologous BCMA-targeted CAR‑T biological therapy) or daratumumab combined with cyclophosphamide, bortezomib and dexamethasone (Dara‑CyBorD). Participants are followed over time to measure hematologic response and organ outcomes, with primary outcome timeframes up to 24 and 60 months.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: January 2027 (estimated)
Primary completion: December 2028 (estimated)
Study completion: December 2032 (estimated)
Target enrollment: 260 participants (estimated)
Last updated on registry: Jul 16, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Nexcella Inc.
Collaborators: Immix Biopharma, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Director, Clinical Trial Operations 📞 888-958-1084 ✉ clinicaltrials@nexcella.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

performance status: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Prior therapy: Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
ICF: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
exclusion criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
Key Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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