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)

July 12, 2026 updated by: Nexcella Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

260

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NXC-201
NXC-201 CAR-T
Biological: NXC-201
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.
Active Comparator: Daratumumab plus CyBorD
Drug: Dara-CyBorD
Daratumumab plus CyBorD combination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months
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
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nexcella Inc.

Collaborators

Immix Biopharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2032

Study Registration Dates

First Submitted

July 12, 2026

First Submitted That Met QC Criteria

July 12, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 12, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NXC-201-AL-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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