NCT07709715

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
72mo left

Started Jan 2027

Longer than P75 for phase_3

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 12, 2026

Last Update Submit

July 12, 2026

Conditions

Light Chain (AL) Amyloidosis

Outcome Measures

Primary Outcomes (2)

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

    CHR rate is defined as percentage of participants who achieved CHR

    24 months

  • Major Organ Deterioration Progression-Free Survival (MOD-PFS)

    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

Study Arms (2)

NXC-201

EXPERIMENTAL

NXC-201 CAR-T

Biological: NXC-201

Daratumumab plus CyBorD

ACTIVE COMPARATOR

Daratumumab plus CyBorD

Drug: Dara-CyBorD

Interventions

NXC-201BIOLOGICAL

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.

NXC-201
Dara-CyBorDDRUG

Daratumumab plus CyBorD combination

Daratumumab plus CyBorD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Director, Clinical Trial Operations

CONTACT

888-958-1084clinicaltrials@nexcella.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2032

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share