[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656495":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":20,"studyPopulation":20,"armGroups":55,"interventions":62,"overallOfficials":69,"centralContacts":73,"locations":83,"responsibleParty":106,"collaborators":20,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":20,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":20,"studyType":121,"phases":122,"briefSummary":125,"conditions":126,"keywords":136,"overallStatus":150,"whyStopped":20,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"AbelZeta Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":20},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence and Severity of Treatment-Emergent Adverse Events","Incidence and severity of treatment-emergent adverse events, serious adverse events, dose-limiting toxicities, CRS, ICANS, adverse events of special interest, and treatment- or procedure-related adverse events.","Through Month 24",{"measure":14,"description":15,"timeFrame":16},"Proportion of Participants With 6-Month Composite Confirmed Disability Progression (6m-cCDP) Through Month 12","Proportion of participants within each Phase 2 cohort experiencing 6-month composite confirmed disability progression through Month 12","Through Month 12",[18,22,24,26,28,30,32,35,37,39,41,43,46],{"measure":19,"description":20,"timeFrame":21},"Proportion of participants with 6m-cCDP - Through Month 12 (Phase 1b)",null,"Through Month 12 (Phase 1b)",{"measure":23,"description":20,"timeFrame":12},"Proportion of participants with 3m-cCDP",{"measure":25,"description":20,"timeFrame":12},"Proportion of participants with 6m-cCDP",{"measure":27,"description":20,"timeFrame":12},"Change from baseline in Expanded Disability Status Scale EDSS)",{"measure":29,"description":20,"timeFrame":12},"Change from baseline in Functional Systems Score (FSS)",{"measure":31,"description":20,"timeFrame":12},"Change from baseline in Timed 25-Foot Walk (T25FW)",{"measure":33,"description":20,"timeFrame":34},"Change from baseline in 9-Hole Peg Test (9-HPT)","Month 12 and Month 24",{"measure":36,"description":20,"timeFrame":12},"Time to first 3m-cCDP",{"measure":38,"description":20,"timeFrame":12},"Time to first 6m-cCDP",{"measure":40,"description":20,"timeFrame":12},"MRI lesion changes",{"measure":42,"description":20,"timeFrame":12},"Incidence and severity of adverse events and serious adverse events",{"measure":44,"description":45,"timeFrame":12},"Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)","Characterize CAR T-cell expansion and persistence using qPCR",{"measure":47,"description":48,"timeFrame":12},"Pharmacokinetics of C-CAR168 utilizing flow cytometry","Characterize T-cell expansion and persistence utilizing flow cytometry",{"allocation":50,"interventionModel":51,"interventionModelDescription":20,"primaryPurpose":52,"observationalModel":20,"timePerspective":20,"maskingInfo":53},"NA","SINGLE_GROUP","TREATMENT",{"masking":54,"maskingDescription":20,"whoMasked":20},"NONE",[56],{"label":57,"type":58,"description":59,"interventionNames":60},"C-CAR168","EXPERIMENTAL","Participants will receive:\n\nLeukapheresis Fludarabine Cyclophosphamide Single intravenous infusion of C-CAR168",[61],"Drug: C-CAR168",[63],{"type":64,"name":57,"description":65,"armGroupLabels":66,"otherNames":67},"DRUG","Autologous anti-CD20\u002FBCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion following lymphodepleting chemotherapy.",[57],[68],"Autologous anti-CD20\u002FBCMA CAR T-cell therapy",[70],{"name":71,"affiliation":5,"role":72},"Yihong Yao, PhD","STUDY_DIRECTOR",[74,79],{"name":75,"role":76,"phone":77,"phoneExt":20,"email":78},"Kirstin Liechty, PhD","CONTACT","240-552-5870","kirstin.liechty@abelzeta.com",{"name":80,"role":76,"phone":81,"phoneExt":20,"email":82},"Nurat Quadri, PhD","1 240 552 5870","clinicaltrials@abelzeta.com",[84,97],{"facility":85,"status":20,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":20},"Research Site","Gilbert","Arizona","85234","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-111.78903,33.35283,{"lat":95,"lon":94},{"facility":85,"status":20,"city":98,"state":99,"zip":100,"country":89,"countryCode":90,"cosmosGeoPoint":101,"geoPoint":105,"contacts":20},"La Jolla","California","92037",{"type":92,"coordinates":102},[103,104],-117.2742,32.84727,{"lat":104,"lon":103},{"type":107,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100656495","phase-1-a-study-of-c-car168-in-participants-with-progressive-multiple-sclerosis-100656495",false,"NCT07825389","C-CAR168, an Autologous Anti-CD20\u002FBCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Progressive Multiple Sclerosis Refractory to Standard Therapy","Multi-center, Phase 1b\u002F2 Clinical Study of an Autologous Anti-CD20\u002FBCMA Chimeric Antigen Receptor T-Cell Therapy (C-CAR168) for the Treatment of Progressive Multiple Sclerosis Refractory to Standard Therapy","Key Inclusion Criteria:\n\n* Able to sign and date the informed consent form.\n* Male or female, 18-55 years of age, body weight \\>=40 kg.\n* Diagnosis of MS according to the 2024 McDonald criteria with cohort-specific progressive MS requirements.\n* Cohort 1: active SPMS; Cohort 2: PPMS or non-active SPMS.\n* Inadequate response to at least one prior high-efficacy disease-modifying therapy administered for at least 6 months.\n* Documented disability progression over the prior 24 months.\n* EDSS 3.0 to 6.5, inclusive.\n* Meets protocol-defined disease-duration, CSF, organ-function, cardiac\u002Fpulmonary, pregnancy testing, contraception, vaccination, and cellular-therapy follow-up requirements.\n\nKey Exclusion Criteria\n\n* RRMS, clinically isolated syndrome, radiologically isolated syndrome, or another diagnosis better explaining the neurologic course.\n* Alternative inflammatory demyelinating disorders, including AQP4-antibody-positive NMOSD and MOG-antibody-associated disease.\n* Active or chronic infection requiring antibiotics, or protocol-specified positive infectious disease testing.\n* Inadequate washout from prior MS therapy or specified recent immunomodulatory treatments.\n* Prior CAR T-cell therapy, other genetically modified immune cell therapy, or gene therapy.\n* Pregnant or breastfeeding, or planning pregnancy during the protocol-defined follow-up period.\n* Specified major cardiovascular, neurologic, transplant, malignancy, bleeding\u002Fthromboembolic, allergy, or protocol-compliance exclusions.","ALL","18 Years","55 Years",{"count":119,"type":120},119,"ESTIMATED","INTERVENTIONAL",[123,124],"PHASE1","PHASE2","This is a global, multicenter, Phase 1b\u002F2 study evaluating the safety and efficacy of C-CAR168, an autologous anti-CD20\u002FBCMA chimeric antigen receptor T-cell therapy, in participants with progressive multiple sclerosis refractory to standard-of-care therapy. The study includes participants with secondary progressive multiple sclerosis (SPMS) and primary progressive multiple sclerosis (PPMS).",[127,128,129,130,131,132,133,134,135],"Multiple Sclerosis","Primary Progressive Multiple Sclerosis","Secondary Progress Multiple Sclerosis (SPMS)","Primary Progressive Multiple Sclerosis (PPMS)","MS","MS (Multiple Sclerosis)","Neuro-Degenerative Disease","Neuro-Degenerative Diseases","Autoimmune",[137,138,139,140,57,141,142,143,128,144,145,146,135,147,148,149],"Progressive Multiple Sclerosis","SPMS","PPMS","CAR T-Cell Therapy","CD20","BCMA","Secondary Progressive Multiple Sclerosis","CAR-T","CAR T cell","CAR T","neurodegenerative","chimeric antigen receptor T cell","Refractory","NOT_YET_RECRUITING","2026-10-07",{"date":153,"type":154},"2026-10-13","ACTUAL",{"date":156,"type":120},"2027-02",{"date":158,"type":120},"2030-02",{"name":5,"class":6},2]