[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647307":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":30,"locations":24,"responsibleParty":36,"collaborators":38,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":24,"enrollmentInfo":51,"targetDuration":24,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":24,"overallStatus":60,"whyStopped":24,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":24},{"fullName":5,"class":6},"Nexcella Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NXC-201","EXPERIMENTAL","NXC-201 CAR-T",[13],"Biological: NXC-201",{"label":15,"type":16,"description":15,"interventionNames":17},"Daratumumab plus CyBorD","ACTIVE_COMPARATOR",[18],"Drug: Dara-CyBorD",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BIOLOGICAL","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.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Dara-CyBorD","Daratumumab plus CyBorD combination",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":24,"email":35},"Director, Clinical Trial Operations","CONTACT","888-958-1084","clinicaltrials@nexcella.com",{"type":37,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[39],{"name":40,"class":6},"Immix Biopharma, Inc.","100647307","phase-3-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-100647307",false,"NCT07709715","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]","NEXICART-3","Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status score ≤2\n2. Newly diagnosed AL Amyloidosis per consensus criteria as defined in the protocol\n3. Measurable disease as defined in the protocol\n4. One or more organs impacted by AL amyloidosis\n\nKey Exclusion Criteria:\n\n1. Prior therapy for AL amyloidosis or multiple myeloma\n2. Diagnosis of multiple myeloma\n3. Cardiac stage IIIb patients\n4. History of malignancy (other than AL amyloidosis) within 3 years\n5. Stroke or seizure within 6 months of signing ICF\n\nNOTE: Other protocol defined inclusion\u002Fexclusion criteria apply","ALL","18 Years",{"count":52,"type":53},260,"ESTIMATED","INTERVENTIONAL",[56],"PHASE3","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.",[59],"Light Chain (AL) Amyloidosis","NOT_YET_RECRUITING","2026-07-12",{"date":63,"type":64},"2026-07-16","ACTUAL",{"date":66,"type":53},"2027-01",{"date":68,"type":53},"2032-12",{"name":5,"class":6}]