[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07038447":3,"trial-entities:NCT07038447":210,"trial-summary:NCT07038447":218},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":64,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":136,"locations":139,"central_contacts":200,"overall_officials":201,"references":205,"see_also_links":206},"NCT07038447","KT-US-720-0203","A Study of KITE-363 in Participants With Refractory Autoimmune Diseases","A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19\u002FCD20 CAR T-cell Therapy in Participants With Refractory Autoimmune Diseases","ENROLLING_BY_INVITATION","2029-07","2026-06","2026-06-16","2025-07-02","Kite, A Gilead Company","INDUSTRY",true,"This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in participants with refractory autoimmune diseases.\n\nThe primary objectives of this study are:\n\nPhase 1a: To evaluate the safety and tolerability of KITE-363 in participants with autoimmune disease. To determine the recommended dose for Phase 1b.\n\nPhase 1b: To evaluate the safety and efficacy of KITE-363 in participants with autoimmune disease.",null,[19,20,21,22],"Systemic Lupus Erythematosus","Lupus Nephritis","Systemic Sclerosis","Idiopathic Inflammatory Myopathy",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE1",{"count":29,"type":30},52,"ESTIMATED",[32,39,44],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BIOLOGICAL","KITE-363","A single infusion of CAR-transduced autologous T cells administered intravenously",[37,38],"Phase 1a: KITE-363 (Dose Escalation)","Phase 1b: KITE-363 (Dose Expansion)",{"type":40,"name":41,"description":42,"armGroupLabels":43},"DRUG","Fludarabine","Administered intravenously",[37,38],{"type":40,"name":45,"description":42,"armGroupLabels":46},"Cyclophosphamide",[37,38],[48,51,53,56,58,60,62],{"measure":49,"timeFrame":50},"Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363","Up to 2 years",{"measure":52,"timeFrame":50},"Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)",{"measure":54,"timeFrame":55},"Phase 1b: Systemic lupus erythematosus (SLE): Proportion of participants meeting DORIS remission and Lupus low Disease Activity State (LLDAS) criteria at Month 6","Month 6",{"measure":57,"timeFrame":55},"Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission",{"measure":59,"timeFrame":55},"Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6",{"measure":61,"timeFrame":55},"Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants With Improvement in Disease Activity by the Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) at Month 6",{"measure":63,"timeFrame":55},"Phase 1b: Idiopathic Inflammatory Myopathy (IIM): Proportions of Participants Meeting European League Against Rheumatism (EULAR)-American College of Rheumatology (ACR) Moderate and Major response 2016 Criteria in Total Improvement Score (TIS) at Month 6",[65,68,70,72,75,77,79,81,84,86,88],{"measure":66,"timeFrame":67},"Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T Cells","Baseline up to 2 years",{"measure":69,"timeFrame":50},"Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cells",{"measure":71,"timeFrame":50},"Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cells",{"measure":73,"description":74,"timeFrame":50},"Pharmacokinetic parameter: AUC for KITE-363 CAR T-cells","AUC is defined as the area under the concentration time curve for KITE-363 CAR T-cells.",{"measure":76,"timeFrame":50},"Pharmacokinetic parameter: Time to Peak Serum Concentration (Tmax) for KITE-363 CAR T-cells",{"measure":78,"timeFrame":50},"Pharmacodynamic Parameters: Serum Concentration of Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors in blood over time",{"measure":80,"timeFrame":50},"Pharmacodynamic Parameters: Peak Serum Concentration (Cmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors",{"measure":82,"description":83,"timeFrame":50},"Pharmacodynamic Parameters: AUC for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors","AUC is defined as the area under the concentration time curve.",{"measure":85,"timeFrame":50},"Pharmacodynamic Parameters: Time to Peak Serum Concentration (Tmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors",{"measure":87,"timeFrame":50},"Percentage of Participants with Antibodies Against KITE-363 CAR T cells",{"measure":89,"timeFrame":50},"Change from Baseline in Levels of B cells","ALL","18 Years",false,{"inclusion":94,"exclusion":113,"raw_text":135},[95,96,97,98,99,100,101,102,95,103,104,105,95,106,107,108,109,110,111,112],"Age ≥ 18 years","Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE","Presence of either double-stranded deoxyribonucleic acid (DNA) anti- double-stranded DNA (anti-dsDNA) and\u002For anti-Smith antibodies at screening per local laboratory.","Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and\u002For neuropsychiatric organ system).","Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin.","For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin","Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN\u002FRPS) criteria within 6 months prior to or during screening","Evidence of active LN at screening","Diffuse Systemic Sclerosis (SSc) according to ACR\u002FEULAR 2013 classification criteria with active skin disease and\u002For progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD.","Refractory or intolerance to 1 of the following for a minimum of 3 months and\u002For contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide.","High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening.","Probable or definite IIM based on EULAR\u002FACR 2017 classification (excluding inclusion body myositis).","Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes","Moderate to severe disease activity","Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM","HRCT scan and PFT within 3 months prior to screening.","Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant\u002Fmodulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent).","Adequate hepatic, renal, pulmonary, and cardiac function.",[114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134],"Females of childbearing potential who are pregnant or breast feeding.","Dialysis within the past year.","History of malignancy, within the last 5 years.","Hypogammaglobulinemia requiring immunoglobulin replacement.","History of autologous or allogeneic stem cell transplant and\u002For organ transplant.","Prior treatment with cellular therapy, gene therapy and\u002For T-cell engager therapy.","Known history of HIV infection, or hepatitis B or C virus infections.","Active or untreated latent tuberculosis (TB).","Active or uncontrolled infections.","Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts.","Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).","Drug-induced SLE.","Catastrophic antiphospholipid syndrome.","Thrombotic thrombocytopenic purpura.","Active or unstable lupus neuropsychiatric manifestations within last 6 months.","Infected digital ulceration or necrosis with signs of infection.","Severe pulmonary hypertension.","History of systemic sclerosis renal crisis within 12 months prior to enrollment.","History of active bleeding related to gastric antral vascular ectasia.","Other inflammatory and noninflammatory myopathies.","Severe, irreversible muscle damage.","Key Inclusion Criteria:\n\nInclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN):\n\n* Age ≥ 18 years\n* Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE\n* Presence of either double-stranded deoxyribonucleic acid (DNA) anti- double-stranded DNA (anti-dsDNA) and\u002For anti-Smith antibodies at screening per local laboratory.\n* Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and\u002For neuropsychiatric organ system).\n* Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin.\n* For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin\n\nInclusion Criteria for LN:\n\n* Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN\u002FRPS) criteria within 6 months prior to or during screening\n* Evidence of active LN at screening\n\nInclusion Criteria for systemic sclerosis (SSc):\n\n* Age ≥ 18 years\n* Diffuse Systemic Sclerosis (SSc) according to ACR\u002FEULAR 2013 classification criteria with active skin disease and\u002For progressive SSc-interstitial lung disease (ILD) OR limited SSc with progressive ILD.\n* Refractory or intolerance to 1 of the following for a minimum of 3 months and\u002For contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide.\n* High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening.\n\nInclusion Criteria for idiopathic inflammatory myopathy (IIM):\n\n* Age ≥ 18 years\n* Probable or definite IIM based on EULAR\u002FACR 2017 classification (excluding inclusion body myositis).\n* Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes\n* Moderate to severe disease activity\n* Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM\n* HRCT scan and PFT within 3 months prior to screening.\n* Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant\u002Fmodulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent).\n\nInclusion Criteria for all Cohorts:\n\n* Adequate hepatic, renal, pulmonary, and cardiac function.\n\nKey Exclusion Criteria:\n\nExclusion Criteria for all Cohorts:\n\n* Females of childbearing potential who are pregnant or breast feeding.\n* Dialysis within the past year.\n* History of malignancy, within the last 5 years.\n* Hypogammaglobulinemia requiring immunoglobulin replacement.\n* History of autologous or allogeneic stem cell transplant and\u002For organ transplant.\n* Prior treatment with cellular therapy, gene therapy and\u002For T-cell engager therapy.\n* Known history of HIV infection, or hepatitis B or C virus infections.\n* Active or untreated latent tuberculosis (TB).\n* Active or uncontrolled infections.\n* Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts.\n\nExclusion Criteria for LN:\n\n* Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).\n\nExclusion Criteria for SLE:\n\n* Drug-induced SLE.\n* Catastrophic antiphospholipid syndrome.\n* Thrombotic thrombocytopenic purpura.\n* Active or unstable lupus neuropsychiatric manifestations within last 6 months.\n\nExclusion Criteria for SSc:\n\n* Infected digital ulceration or necrosis with signs of infection.\n* Severe pulmonary hypertension.\n* History of systemic sclerosis renal crisis within 12 months prior to enrollment.\n* History of active bleeding related to gastric antral vascular ectasia.\n\nExclusion Criteria for IIM:\n\n* Other inflammatory and noninflammatory myopathies.\n* Severe, irreversible muscle damage.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",[137,138],"ADULT","OLDER_ADULT",[140,149,156,164,171,177,185,193],{"facility":141,"city":142,"state":143,"zip":144,"country":145,"geoPoint":146},"City of Hope","Duarte","California","91010","United States",{"lat":147,"lon":148},34.13945,-117.97729,{"facility":150,"city":151,"state":143,"zip":152,"country":145,"geoPoint":153},"Stanford University","Stanford","94305",{"lat":154,"lon":155},37.42411,-122.16608,{"facility":157,"city":158,"state":159,"zip":160,"country":145,"geoPoint":161},"Tampa General Hospital Cancer Institute","Tampa","Florida","33606",{"lat":162,"lon":163},27.94752,-82.45843,{"facility":165,"city":166,"state":166,"zip":167,"country":145,"geoPoint":168},"Icahn School of Medicine at Mount Sinai","New York","10029",{"lat":169,"lon":170},40.71427,-74.00597,{"facility":172,"city":173,"state":174,"zip":175,"country":176},"Concord Repatriation General Hospital","Syndey","New South Wales","2139","Australia",{"facility":178,"city":179,"state":180,"zip":181,"country":176,"geoPoint":182},"St Vincent's Hospital","Fitzroy","Victoria","3065",{"lat":183,"lon":184},-37.79839,144.97833,{"facility":186,"city":187,"zip":188,"country":189,"geoPoint":190},"Jewish General Hospital","Montreal","H3T1E2","Canada",{"lat":191,"lon":192},45.50884,-73.58781,{"facility":194,"city":195,"zip":196,"country":189,"geoPoint":197},"The Ottawa Hospital, General Campus","Ottawa","K1H 8L6",{"lat":198,"lon":199},45.41117,-75.69812,[],[202],{"name":203,"affiliation":13,"role":204},"Kite Study Director","STUDY_DIRECTOR",[],[207],{"label":208,"url":209},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07038447",{"nct_id":4,"conditions":211,"biomarkers":214},[22,212,19,213],"Lupus Glomerulonephritis","Systemic Scleroderma",[215,216,217],"Anti-ds DNA Antibody","Anti-Smith Antibody","myositis specific antibodies",{"nct_id":4,"found":92,"summary":17,"prompt_version":17}]