Light Chain (AL) AmyloidosisPhase 3NEXICART-3NCT07709715
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 Phase 3 study testing NXC-201 and Dara-CyBorD in people with Light Chain (AL) Amyloidosis, run by Nexcella Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Light Chain (AL) Amyloidosis
- What is being tested?
- NXC-201 and Dara-CyBorD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Dec 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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]
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
- Being tested
- NXC-201, Dara-CyBorD
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Dara-CyBorDDrug
Daratumumab plus CyBorD combination
| Study group | Role | What they receive |
|---|---|---|
| NXC-201 | Experimental | NXC-201 CAR-T Receives: Biological: NXC-201 |
| Daratumumab plus CyBorD | Active comparator | Daratumumab plus CyBorD Receives: Drug: Dara-CyBorD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Light Chain (AL) AmyloidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexcella Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immix Biopharma, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07709715
- Sponsor's protocol ID
- NXC-201-AL-002
- Acronym
- NEXICART-3
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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]
- ClinicalTrials.gov ID
- NCT07709715
- Acronym / sponsor ID
- NEXICART-3 / NXC-201-AL-002
- Conditions
- Light Chain (AL) Amyloidosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Nexcella Inc.Industry (pharma, biotech, devices)
- Collaborators
- Immix Biopharma, Inc.
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NXC-201 | Experimental | Biological: NXC-201NXC-201 CAR-T |
| Daratumumab plus CyBorD | Active comparator | Drug: Dara-CyBorDDaratumumab plus CyBorD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXC-201NXC-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. | Biological | NXC-201 |
| Dara-CyBorDDaratumumab plus CyBorD combination | Drug | Daratumumab plus CyBorD |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Light Chain (AL) Amyloidosis
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
Active, not recruitingPhase 1
Study of Captisol Enabled Melphalan and Pharmacokinetics for Patients With Multiple Myeloma or Light Chain Amyloidosis That Are Receiving an Autologous Transplant.
Multiple Myeloma, Amyloidosis
Active, not recruitingPhase 1/2
Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Amyloidosis
AL Amyloidosis
RecruitingPhase 2
Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial
AL Amyloidosis
RecruitingObservational study
SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders
AL Amyloidosis, Multiple Myeloma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NXC-201 and Dara-CyBorD in people with Light Chain (AL) Amyloidosis, run by Nexcella Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Director, Clinical Trial Operations (888-958-1084, clinicaltrials@nexcella.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall complete hematologic response (CHR) rate using consensus recommendations for AL amyloidosis treatment response criteria per protocol (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.