[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658607":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":47,"overallOfficials":52,"centralContacts":56,"locations":64,"responsibleParty":78,"collaborators":33,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":33,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":33,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":104,"overallStatus":115,"whyStopped":33,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"AbelZeta Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"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",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Proportion of Participants Achieving Response","Proportion of participants achieving a response per the revised Composite Response Index for Systemic Sclerosis (r-CRISS)",{"measure":18,"description":19,"timeFrame":12},"Pharmacokinetics of C-CAR168 Utilizing Flow Cytometry","Characterize T-cell expansion and persistence utilizing flow cytometry",{"measure":21,"description":22,"timeFrame":12},"Pharmacokinetics of C-CAR168 measured by quantitative polymerase chain reaction (qPCR)","Characterize CAR T-cell expansion and persistence using qPCR",{"measure":24,"description":25,"timeFrame":12},"Proportion of Participants Progressed","Proportion of participants that progress meeting any of the protocol defined progression criteria",{"measure":27,"description":28,"timeFrame":12},"Time to First Response","Time to participant meeting first response as defined in the protocol",{"measure":30,"description":31,"timeFrame":32},"Duration of Response (DOR)","Time of response from first response until progression as defined in the protocol","Through 24 months",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"C-CAR168","EXPERIMENTAL","Participants will receive: • Leukapheresis • Fludarabine • Cyclophosphamide • Single intravenous infusion of C-CAR168",[46],"Biological: C-CAR168",[48],{"type":49,"name":42,"description":50,"armGroupLabels":51,"otherNames":33},"BIOLOGICAL","Autologous anti-CD20\u002FBCMA chimeric antigen receptor T-cell therapy administered as a single intravenous infusion",[42],[53],{"name":54,"affiliation":5,"role":55},"Yihong Yao, PhD","STUDY_DIRECTOR",[57,62],{"name":58,"role":59,"phone":60,"phoneExt":33,"email":61},"Kirstin Liechty, Head of Clinical Operations, PhD","CONTACT","267-566-6081","kirstin.liechty@abelzeta.com",{"name":63,"role":59,"phone":60,"phoneExt":33,"email":61},"Yihong Liechty, Head of Clinical Operations, PhD",[65],{"facility":66,"status":33,"city":67,"state":68,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":33},"Research Site","Gilbert","Arizona","85234","United States","US",{"type":73,"coordinates":74},"Point",[75,76],-111.78903,33.35283,{"lat":76,"lon":75},{"type":79,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100658607","phase-1-a-phase-1b-study-of-c-car168-in-participants-with-systemic-sclerosis-ssc-100658607",false,"NCT07854483","C-CAR168, an Autologous Anti-CD20\u002FBCMA Chimeric Antigen Receptor T-Cell Therapy, in Participants With Systemic Sclerosis (SSc) Refractory to Standard Therapy","A Multi-center, Phase 1b Clinical Study of an Autologous Anti-CD20\u002FBCMA Chimeric Antigen Receptor T-Cell Therapy (C-CAR168) for the Treatment of Systemic Sclerosis (SSc) Refractory to Standard Therapy","Key Inclusion Criteria:\n\n1. Able to sign and date the Informed Consent Form (ICF).\n2. Female or male, aged 18-70 years (inclusive) with body weight ≥40 kg.\n3. Have a clinical diagnosis of diffuse cutaneous SSc according to the 2013 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification.\n4. Disease duration between the onset of the first non-Raynaud's sign\u002Fsymptom and ICF signing shall be ≤ 6 years.\n5. SSc Disease Activity meet all following criteria:\n\n   1. Modified Rodnan Skin Score (mRSS) ≥15.\n   2. Chest High Resolution Computed Tomography (HRCT) shows SSc related ground-glass opacities.\n   3. Percent predicted forced vital capacity (ppFVC)\\\u003C70% or precent predicted (diffusing capacity of the lungs for carbon monoxide) ppDLco\\\u003C70%.\n6. Positivity for at least one SSc-specific autoantibodies:\n\n   1. anti-Scl70 antibody.\n   2. anti-RNA polymerase III antibody.\n   3. anti-centromere antibody.\n   4. anti-Th\u002FTo antibody.\n   5. and anti-U3RNP antibody.\n7. Refractory to at least two prior standard-of-care regimens, including immunosuppressives and\u002For a biologic note: \"Refractory\" is defined as receiving each listed drug for ≥6 months with either no response, disease progression after transient remission, or persistent disease progression on treatment.\n8. Ability to taper steroids to protocol allowed doses\n\nExclusion Criteria:\n\n1. ppFVC\\\u003C45% or ppDLco \\\u003C40%.\n2. Severe pulmonary arterial hypertension (PAH) as measured by screening echocardiogram (ECHO), or had documented mean positive airway pressure PAP (mPAP) \\> 45mmHg on recent right heart catheterization (RHC).\n\n   Note: RHC is not mandatory at screening, however participant with high-risk ECHO findings warrant close clinical vigilance, and participant with mPAP\\> 45mmHg at baseline shall not proceed with lymphodepletion.\n3. Presence of clinically significant abnormalities on chest high-resolution computed tomography (HRCT) that are UNRELATED to SSc.\n4. Cutaneous sclerosis that impedes venous access required for leukapheresis, lymphodepletion, C-CAR168 infusion, other study procedures and emergency rescue interventions.","ALL","18 Years","70 Years",{"count":91,"type":92},12,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This Phase 1b, multicenter, open-label study will evaluate the safety and efficacy of a single infusion of autologous anti-CD20\u002FBCMA chimeric antigen receptor T cells (C-CAR168) following lymphodepleting chemotherapy in participants with refractory Systemic Sclerosis (SSc) who are not responding to standard therapy. Approximately 6-12 participants will undergo leukapheresis, lymphodepletion with fludarabine and cyclophosphamide, and infusion of C-CAR168. Participants will be followed for 24 months (2 years) to evaluate safety, CAR T-cell persistence, pharmacokinetics\u002Fpharmacodynamics, biomarkers, and preliminary efficacy results. Long-term safety follow-up for gene therapy-related events will continue for up to 15 years following CAR T-cell infusion.",[98,99,100,101,102,103],"Systemic Sclerosis (SSc)","Systemic Sclerosis","Systemic Sclerosis (Scleroderma)","Systemic Sclerosis - 2013 ACR\u002FEULAR Classification Criteria","Systemic Sclerosis Pulmonary","Systemic Sclerosis With Lung Involvement",[105,106,107,99,108,109,110,111,112,113,114],"Autoimmune","CAR-T","CAR T-cell Therapy","SSc","Autoimmune disease","CD20","BCMA","CAR-T Therapy","Chimeric Antigen Receptor T cell","chimeric antigen receptor T-cell Therapy","NOT_YET_RECRUITING","2026-10-07",{"date":118,"type":119},"2026-10-13","ACTUAL",{"date":121,"type":92},"2027-03",{"date":123,"type":92},"2030-03",{"name":5,"class":6},1]