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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

NCT07709715 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-07-16

No results posted yet for this study

Summary

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.

Conditions

  • Light Chain (AL) Amyloidosis

Interventions

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.

DRUG

Dara-CyBorD

Daratumumab plus CyBorD combination

Sponsors & Collaborators

  • Immix Biopharma, Inc.

    collaborator INDUSTRY

  • Nexcella Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-12-31
Completion
2032-12-31
FDA Drug
Yes

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07709715 on ClinicalTrials.gov