[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07085104":3,"trial-entities:NCT07085104":279,"trial-summary:NCT07085104":284},{"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":22,"study_type":41,"primary_purpose":42,"phases":43,"enrollment_info":45,"interventions":48,"primary_outcomes":64,"secondary_outcomes":69,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":98,"locations":101,"central_contacts":267,"overall_officials":273,"references":277,"see_also_links":278},"NCT07085104","ALLO-329-101","A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease","A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19\u002FAnti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease","RECRUITING","2032-10","2026-07","2026-07-31","2025-11-13","Allogene Therapeutics","INDUSTRY",true,"This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).",null,[19,20,21],"Systemic Lupus Erythematosus (With and Without Nephritis)","Idiopathic Inflammatory Myopathy","Systemic Sclerosis",[23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Idiopathic inflammatory myopathy","IIM","Myositis","Dermatomyositis","Anti-synthetase syndrome","Systemic sclerosis","Scleroderma","SSc","Autoimmune disease","CAR T","Allogeneic CAR T","CD19","CD70","AlloCAR T","INTERVENTIONAL","TREATMENT",[44],"PHASE1",{"count":46,"type":47},66,"ESTIMATED",[49,56,61],{"type":50,"name":51,"description":52,"armGroupLabels":53},"GENETIC","ALLO-329","An allogeneic CAR T cell therapy targeting CD19 and CD70",[51,54,55],"ALLO-329, Cyclophosphamide","ALLO-329, Cyclophosphamide, Fludarabine",{"type":57,"name":58,"description":59,"armGroupLabels":60},"DRUG","Cyclophosphamide","Chemotherapy for lymphodepletion",[54,55],{"type":57,"name":62,"description":59,"armGroupLabels":63},"Fludarabine",[55],[65],{"measure":66,"description":67,"timeFrame":68},"Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters","The incidence of dose limiting toxicities (DLTs) and other safety parameters (including but not limited to treatment emergent adverse events \\[AEs\\], serious adverse events \\[SAEs\\], and clinical laboratory abnormalities)","Up to 60 months",[70,73,75,78,81,84,86,88],{"measure":71,"description":72,"timeFrame":68},"Disease Response to Treatment - Systemic Lupus Erythematosus","Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.",{"measure":71,"description":74,"timeFrame":68},"Efficacy as assessed by change from baseline in SLEDAI-2K score.",{"measure":76,"description":77,"timeFrame":68},"Disease Response to Treatment - Lupus Nephritis","Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).",{"measure":79,"description":80,"timeFrame":68},"Disease Response to Treatment - Idiopathic Inflammatory Myopathy","Efficacy as assessed by ACR\u002FEULAR myositis response criteria components.",{"measure":82,"description":83,"timeFrame":68},"Disease Response to Treatment - Systemic Sclerosis","Efficacy as assessed by change from baseline in the European Scleroderma Trials and Research Group (EUSTAR) activity index.",{"measure":82,"description":85,"timeFrame":68},"Efficacy as assessed by change from baseline in the American College of Rheumatology Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS).",{"measure":87,"timeFrame":68},"ALLO-329 Peak Expansion (Cmax)",{"measure":89,"timeFrame":68},"ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC)","ALL","18 Years","74 Years",false,{"inclusion":95,"exclusion":96,"raw_text":97},[],[],"Inclusion Criteria:\n\n1. Adults ≥ 18 to \\\u003C 75 years of age.\n2. Adequate hematological function and liver, cardiac, and pulmonary function.\n3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.\n4. Signed and dated informed consent form.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and\u002For laboratory testing.\n7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months.\n\nExclusion Criteria:\n\n1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.\n2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor.\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study.\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).\n5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.\n6. Child-Pugh Class B or C cirrhosis.\n7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing.\n8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.\n9. Any form of primary, inherited immunodeficiency.\n10. Unwilling to participate in an extended safety monitoring period.\n11. For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and\u002For interstitial fibrosis.\n12. Participants with IIM: A myositis other than specified classification per exclusion criteria, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.\n13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.",[99,100],"ADULT","OLDER_ADULT",[102,115,126,137,147,158,169,180,191,202,212,223,234,244,255],{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":107,"contacts":108,"geoPoint":112},"Mayo Clinic","Phoenix","Arizona","85054","United States",[109],{"name":110,"role":111},"Vivek Nagaraja, MD","PRINCIPAL_INVESTIGATOR",{"lat":113,"lon":114},33.44838,-112.07404,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":107,"contacts":120,"geoPoint":123},"Loma Linda University Medical Center","Loma Linda","California","92354",[121],{"name":122,"role":111},"Hisham Abdel-Azim, MD",{"lat":124,"lon":125},34.04835,-117.26115,{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":107,"contacts":131,"geoPoint":134},"University of Colorado Denver","Aurora","Colorado","80045",[132],{"name":133,"role":111},"Melissa Griffith, MD",{"lat":135,"lon":136},39.72943,-104.83192,{"facility":103,"status":8,"city":138,"state":139,"zip":140,"country":107,"contacts":141,"geoPoint":144},"Jacksonville","Florida","32224",[142],{"name":143,"role":111},"Vikas Majithia, MD",{"lat":145,"lon":146},30.33218,-81.65565,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":107,"contacts":152,"geoPoint":155},"The University of Chicago Medical Center","Chicago","Illinois","60637",[153],{"name":154,"role":111},"Michael Macklin, MD",{"lat":156,"lon":157},41.85003,-87.65005,{"facility":159,"status":8,"city":160,"state":161,"zip":162,"country":107,"contacts":163,"geoPoint":166},"University of Iowa","Iowa City","Iowa","52242",[164],{"name":165,"role":111},"Hanna Zembrzuska, MD",{"lat":167,"lon":168},41.66113,-91.53017,{"facility":170,"status":8,"city":171,"state":172,"zip":173,"country":107,"contacts":174,"geoPoint":177},"University of Kansas Medical Center","Kansas City","Kansas","66160",[175],{"name":176,"role":111},"Paul Schmidt, MD",{"lat":178,"lon":179},39.11417,-94.62746,{"facility":181,"status":8,"city":182,"state":183,"zip":184,"country":107,"contacts":185,"geoPoint":188},"Norton Cancer Institute, St. Matthews Campus","Louisville","Kentucky","40207",[186],{"name":187,"role":111},"Don Stevens, MD",{"lat":189,"lon":190},38.25424,-85.75941,{"facility":192,"status":8,"city":193,"state":194,"zip":195,"country":107,"contacts":196,"geoPoint":199},"Astera Cancer Care","East Brunswick","New Jersey","08816",[197],{"name":198,"role":111},"Birju Bhatt, MD",{"lat":200,"lon":201},40.42788,-74.41598,{"facility":203,"status":8,"city":204,"state":204,"zip":205,"country":107,"contacts":206,"geoPoint":209},"Icahn School of Medicine at Mount Sinai","New York","10029",[207],{"name":208,"role":111},"Margrit Wiesendanger, MD",{"lat":210,"lon":211},40.71427,-74.00597,{"facility":213,"status":8,"city":214,"state":215,"zip":216,"country":107,"contacts":217,"geoPoint":220},"Duke University Medical Center","Durham","North Carolina","27710",[218],{"name":219,"role":111},"Lisa Criscione-Schreiber, MD",{"lat":221,"lon":222},35.99403,-78.89862,{"facility":224,"status":8,"city":225,"state":226,"zip":227,"country":107,"contacts":228,"geoPoint":231},"Medical University of South Carolina","Charleston","South Carolina","29605",[229],{"name":230,"role":111},"Melissa Cunningham, MD",{"lat":232,"lon":233},32.77632,-79.93275,{"facility":235,"status":8,"city":236,"state":226,"zip":237,"country":107,"contacts":238,"geoPoint":241},"Prisma Health","Greenville","29425",[239],{"name":240,"role":111},"Cory McGee, MD",{"lat":242,"lon":243},34.85262,-82.39401,{"facility":245,"status":8,"city":246,"state":247,"zip":248,"country":107,"contacts":249,"geoPoint":252},"LDS Hospital - lntermountain Health","Salt Lake City","Utah","84143",[250],{"name":251,"role":111},"Pankhuri Gupta, MD",{"lat":253,"lon":254},40.76078,-111.89105,{"facility":256,"status":8,"city":257,"state":258,"zip":259,"country":260,"contacts":261,"geoPoint":264},"Hôpital Maisonneuve Rosemont","Montreal","Quebec","H1T 2M4","Canada",[262],{"name":263,"role":111},"Nicolas Richard, MD",{"lat":265,"lon":266},45.50884,-73.58781,[268],{"name":269,"role":270,"phone":271,"email":272},"Allogene Therapeutics, Inc.","CONTACT","+1 415-604-5696","clinicaltrials@allogene.com",[274],{"name":275,"affiliation":269,"role":276},"Allogene Study Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":280,"biomarkers":283},[20,281,282],"Systemic Lupus Erythematosus","Systemic Scleroderma",[],{"nct_id":4,"found":15,"summary":285,"prompt_version":295},{"design":286,"status":287,"heading":288,"summary":289,"follow_up":290,"word_count":291,"commitments":292,"compensation":293,"drugs_mentioned":294},"This is a first-in-human, single-arm, open-label study, meaning all participants receive the same treatment and both you and the researchers will know what treatment you are getting. It plans to enroll 66 participants.","completed","ALLO-329 for Autoimmune Diseases","This study is testing a new cell therapy called ALLO-329 for adults with certain autoimmune diseases like lupus (Systemic Lupus Erythematosus), muscle inflammation (Idiopathic Inflammatory Myopathy), and hardened skin (Systemic Sclerosis). ALLO-329 is a type of CAR T-cell therapy, which uses specially modified immune cells to target specific cells in your body. Before receiving ALLO-329, you would also receive chemotherapy drugs, Cyclophosphamide and Fludarabine. The main goal is to see how safe ALLO-329 is and if it causes any serious side effects. Researchers also want to see if it shows early signs of helping with these conditions. The study is currently unclear on its recruitment status and plans to enroll 66 participants aged 18 to 74 years.","Your safety will be monitored for up to 60 months (5 years) after treatment.",117,"Not specified in the trial record.","Not stated in the trial record.",[51,58,62],"v2"]