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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

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]

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07709715
Acronym
NEXICART-3
Enrollment
260
Registered
2026-07-16
Start date
2027-01-01
Completion date
2032-12-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Light Chain (AL) Amyloidosis

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.

Interventions

BIOLOGICALNXC-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.

DRUGDara-CyBorD

Daratumumab plus CyBorD combination

Sponsors

Nexcella Inc.
Lead SponsorINDUSTRY
Immix Biopharma, Inc.
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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/

Design outcomes

Primary

MeasureTime frameDescription
Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol24 monthsCHR rate is defined as percentage of participants who achieved CHR
Major Organ Deterioration Progression-Free Survival (MOD-PFS)60 monthsMOD-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

Contacts

CONTACTDirector, Clinical Trial Operations
clinicaltrials@nexcella.com888-958-1084

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026