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NCT Number: 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

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.

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Key information

Conditions

Light Chain (AL) Amyloidosis Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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

Treatment and study plan

NXC-201

Biological

NXC-201 CAR-T is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding a proprietary chimeric antigen receptor (CAR) targeted to human BCMA.

Dara-CyBorD

Drug

Daratumumab plus CyBorD combination

Primary outcomes

  1. Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol

    Time frame: 24 months

    CHR rate is defined as percentage of participants who achieved CHR

  2. Major Organ Deterioration Progression-Free Survival (MOD-PFS)

    Time frame: 60 months

    MOD-PFS is defined as duration from the date of randomization to either hematologic progression, or major organ deterioration (clinical manifestation of cardiac failure or renal failure), or death, whichever occurs first

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Clinical Trial Operations

CONTACT

[email protected]

888-958-1084

Sponsors and collaborators

Lead sponsor

Nexcella Inc.

Industry

Collaborators

  • Immix Biopharma, Inc.

Registry information

Official study title

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]

Acronym: NEXICART-3

Important dates

Study start
2027
Primary completion
2028
Study completion
2032
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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