[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"systemic-sclerosis-with-lung-involvement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:systemic-sclerosis-with-lung-involvement":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"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":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Systemic Sclerosis (SSc)","Systemic Sclerosis","Systemic Sclerosis (Scleroderma)","Systemic Sclerosis - 2013 ACR\u002FEULAR Classification Criteria","Systemic Sclerosis Pulmonary","Systemic Sclerosis With Lung Involvement",[34,35,36,28,37,38,39,40,41,42,43],"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":47,"type":48},"2026-10-13","ACTUAL",{"date":50,"type":21},"2027-03",{"date":52,"type":21},"2030-03",{"name":54,"class":55},"AbelZeta Inc.","INDUSTRY",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":22,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100499577","phase-2-mycophenolate-mofetil-in-systemic-sclerosis-with-subclinical-interstitial-lung-disease-100499577","NCT05785065","Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease","Randomized Double-Blind Placebo-Controlled Clinical Trial to Assess the Efficacy of Mycophenolate Mofetil in Subclinical Interstitial Lung Disease Associated With Systemic Sclerosis: a Feasibility Study","SSc-mILD","Inclusion Criteria:\n\n1. Able and willing to provide informed consent and adhere to study protocol;\n2. Women and men of all race\u002Fethnicity, aged 18 years and older;\n3. SSc based on 2013 ACR-EULAR classification criteria;\n4. Presence of interstitial lung disease on HRCT scan, obtained within 12 months before screening, that shows fibrosis affecting less than 20% of the lungs, as confirmed by an expert radiologist;\n5. Diagnosis of ILD within 7 years before screening;\n6. Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening;\n7. Able to communicate in French or English;\n\nExclusion Criteria:\n\n1. Progressive pulmonary fibrosis, defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation, as defined by the 2022 ATS\u002FERS\u002FJRS\u002FALAT Clinical Practice Guideline;\n2. Use of medications with putative lung disease-modifying properties:\n\n   1. Current use of MMF, mycophenolic acid, azathioprine, calcineurin inhibitors (e.g. tacrolimus, cyclosporin A), tocilizumab, nintedanib, pirfenidone or corticosteroids (Prednisone equivalent dose \\>10 mg\u002Fday) at time of screening\n   2. Cyclophosphamide within one year prior to screening\n   3. Rituximab within 6 months prior to screening\n   4. Cell therapies (including stem cell transplantation) within one year prior to screening\n3. Current use of other biological, targeted synthetic or investigational products with immunosuppressive effects (e.g. TNF inhibitors, abatacept, tofacitinib) at time of screening\n4. Any contraindication to MMF, including:\n\n   1. Pregnancy and\u002For breastfeeding\n   2. Female of childbearing potential not using reliable method of contraception\n   3. Persistent leucopenia (white blood cell count \\\u003C3.0 x103\u002FμL)\n   4. Persistent thrombocytopenia (platelet count \\\u003C100 x103\u002FμL)\n   5. Persistent anemia (hemoglobin \\\u003C100 g\u002FL)\n   6. Baseline liver enzymes (alanine transaminase (ALT) or aspartate transaminase (AST)) or bilirubin \\>1.5 times the upper limit of normal, other than due to Gilbert's disease\n   7. Uncontrolled congestive heart failure\n   8. Active infection (lung or elsewhere)\n   9. Active solid or hematological malignancy (other than basal cell cancer of the skin or cervical carcinoma in situ removed entirely by biopsy)\n   10. Active peptic ulcer disease\n   11. Other serious concomitant medical illness, unreliability or drug abuse that might compromise the patient's ability to safely take MMF\n   12. Use of drugs or products with significant interactions with MMF",{"count":66,"type":21},35,[68],"PHASE2","The goal of this pilot study is to assess the feasibility of a larger study on the efficacy of mycophenolate mofetil in people diagnosed with systemic sclerosis with mild lung involvement. Participants will be recruited over 12 months at 3 academic centers and assigned randomly to receive either mycophenolate mofetil or placebo, a look-alike substance that contains no active drug, for 96 weeks.",[32,28,71],"Interstitial Lung Disease",[73,74,75],"Systemic sclerosis","Mycophenolate mofetil","Interstitial lung disease","RECRUITING","2026-09-25",{"date":79,"type":48},"2026-09-29",{"date":81,"type":48},"2024-08-29",{"date":83,"type":21},"2028-12",{"name":85,"class":86},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",3]