[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fate Therapeutics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":140},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,58,88,118],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":57},"100539833","phase-1-a-phase-1-study-of-ft819-in-b-cell-mediated-autoimmune-disease-100539833",false,"NCT06308978","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Disease","Key Inclusion Criteria:\n\n* Age: 12 to 70 years old.\n* Diagnosis: Must have active B-cell mediated autoimmune disease (SLE, AAV, IIM, or SSc) confirmed by standard criteria.\n* Disease Severity: Moderate to severe, requiring at least two prior treatments that were ineffective.\n* Health Status: Adequate organ function to tolerate treatment.\n* Consent: Able to provide informed consent or assent\u002Fobtain parental consent and comply with study procedures.\n\nKey Exclusion Criteria:\n\n* Pregnancy\u002FBreastfeeding: Women must not be pregnant or nursing.\n* Severe Organ Dysfunction: Significant heart, lung, liver, or kidney impairment.\n* Active Infections: No recent or ongoing serious infections.\n* Recent Cancer or Prior Cell Therapy: No active\u002Frecent malignancies, prior CAR T-cell therapy, or organ transplant.\n* Allergies: No known allergies to study treatments.\n* Weight Restriction: Must weigh at least 50 kg (110 lbs).","ALL","12 Years","70 Years",{"count":19,"type":20},244,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following treatment with or without auxiliary medicinal product (AMP) in participants with moderate-to-severe active systemic lupus erythematosus (SLE) with or without nephritis, antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV), idiopathic inflammatory myositis (IIM), and systemic sclerosis (SSc). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819.",[26,27,28,29,30],"Antineutrophilic Cytoplasmic Antibody (ANCA)- Associated Vasculitis (AAV)","Idiopathic Inflammatory Myositis (IIM)","Systemic Sclerosis (SSc)","Systemic Lupus Erythematosus (SLE)","Lupus Nephritis",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,30],"FT819","Fate Therapeutics","Idiopathic inflammatory myositis (IIM)","Systemic lupus erythematosus (SLE)","Systemic sclerosis (SSc)","Antineutrophilic cytoplasmic antibody (ANCA)-associated vasculitis (AAV)","Allogeneic CAR-T","CD19-Targeted Therapy","Cell Therapy for Autoimmune Diseases","B-Cell Depletion in Autoimmune Disease","Phase 1 Clinical Trial","Allogeneic CAR cells","Autoimmune Diseases","A Phase 1 Study of FT819 in B-cell Mediated Autoimmune Diseases","RECRUITING","2026-05-19",{"date":49,"type":50},"2026-05-22","ACTUAL",{"date":52,"type":50},"2024-03-28",{"date":54,"type":20},"2042-09-30",{"name":33,"class":56},"INDUSTRY",21,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":66,"targetDuration":4,"studyType":21,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100636836","phase-2-a-phase-2-open-label-single-arm-trial-of-ft819-in-participants-with-lupus-nephritis-100636836","NCT07570862","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Lupus Nephritis","A Phase 2, Open-Label, Single-Arm Trial of FT819 in Participants With Refractory Moderate-to-Severe Systemic Lupus Erythematosus With Lupus Nephritis (RECLAIM-LN)","RECLAIM-LN","INCLUSION CRITERIA:\n\n* Age ≥12 to ≤70 years\n* Diagnosis of SLE per EULAR\u002FACR 2019 classification criteria\n* Biopsy-proven proliferative Class III or IV LN, with or without concomitant Class V involvement, based on the 2003\u002F2018 ISN\u002FRPS classification\n* Positivity for at least one of the following autoantibodies at screening:\n\n  1. Antinuclear antibody (ANA)\n  2. Anti-double-stranded DNA (anti-dsDNA) or\n  3. Anti-Smith antibody\n* Active disease, defined as:\n\n  a. Evidence of SLE activity, defined as either: i. SLEDAI-2K ≥6 or ii. At least 1 BILAG A or 2 BILAG B scores for SLE-related organ involvement; and b. Evidence of renal involvement, defined as UPCr ≥1 g\u002Fg; and c. Moderate-to-severe renal disease with investigator's impression that improvement is possible\n* Refractory to ≥2 systemic immunosuppressive therapies for the treatment of LN\n\nEXCLUSION CRITERIA:\n\n* Evidence of inadequate organ function during the screening period\n* Active central nervous system (CNS) symptoms attributable to autoimmune disease within 12 months prior to trial intervention\n* History of or current renal diseases (other than LN) that, in the opinion of the investigator, could interfere with assessment of LN or confound evaluation of disease activity\n* Receipt of dialysis (hemodialysis or peritoneal dialysis) within 12 weeks of trial intervention\n* Irreversible organ damage related to underlying disease (e.g., ESRD) where, in the opinion of the investigator, CD19 CAR T-cell therapy would be unlikely to benefit the participant\n* History of malignancy in the prior 5 years\n* Known allergy to the following FT819 components: albumin (human) or DMSO\n* History of intolerance or contraindication to bendamustine\n* Body weight \\\u003C30 kg\n* Any medical condition, clinical laboratory abnormality, or nonmedical\u002Fsocial issue that, per investigator or medical monitor judgement, precludes safe participation in and completion of the trial or that could affect compliance with protocol conduct or interpretation of results",{"count":67,"type":20},53,[69],"PHASE2","The primary objective of this trial is to evaluate the efficacy and safety of FT819, comprised of allogeneic T cells that express a CD19-targeted CAR, following bendamustine administration in participants with refractory moderate-to-severe lupus nephritis, as assessed by the proportion of participants who achieve complete renal response (CRR) at Week 26.",[30,72,73,74,75],"Systemic Lupus Erythematosus","SLE - Systemic Lupus Erythematosus","Lupus Nephritis - WHO Class III","Lupus Nephritis - WHO Class IV",[32,33,77,78,30,72],"Allogeneic CAR T","CD19 - targeted therapy","NOT_YET_RECRUITING","2026-05-07",{"date":82,"type":50},"2026-05-11",{"date":84,"type":20},"2026-07-01",{"date":86,"type":20},"2030-01-31",{"name":33,"class":56},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":95,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":107,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},"100609555","phase-1-ft836-with-or-without-chemotherapy-andor-monoclonal-antibodies-in-participants-with-advanced-solid-tumors-100609555","NCT07216105","FT836 With or Without Chemotherapy and\u002For Monoclonal Antibodies, in Participants With Advanced Solid Tumors","A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and\u002For Monoclonal Antibodies, in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n* For all regimens, disease that is not amenable to curative therapy and that has relapsed or progressed following at least one line of prior systemic therapy.\n* Evidence of adequate organ function as determined by all of the following:\n\n  * Absolute neutrophil count (ANC) \\>1000\u002FµL without growth factor support within 7 days prior to start of first study intervention\n  * Platelet count ≥75,000\u002FµL without transfusion support within 14 days prior to start of first study intervention\n  * Estimated creatinine clearance ≥50 mL\u002Fminute by Cockcroft-Gault method or other standard institutional method\n  * Total bilirubin ≤1.5 × upper limit of normal (ULN); for participants with documented Gilbert syndrome, total bilirubin must be ≤3 ×ULN\n  * Aspartate transaminase (AST) ≤3 × ULN or alanine transaminase (ALT) ≤3 × ULN; in participants with documented liver metastases, AST or ALT ≤5 × ULN\n  * Alkaline phosphatase (ALP) ≤2.5 × ULN; in participants with documented liver or bone metastases, ALP ≤5 × ULN\n  * Oxygen saturation \\>90% on room air\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n* Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention.\n* Presence of baseline safely accessible lesions of adequate size for on-treatment biopsies (exceptions for lesion size may be granted with medical monitor approval) and participant willingness to undergo protocol prescribed on-treatment biopsies.\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular disease including any of the following: uncontrolled\u002F unstable cardiac arrhythmias, myocardial infarction within 6 months prior to start of first study intervention, unstable angina or congestive heart failure of New York Heart Association (NYHA) Grade 2 or higher, or cardiac ejection fraction \\\u003C50%.\n* Receipt of any biological therapy, chemotherapy, investigational therapy, or radiation therapy within 2 weeks or five half-lives prior to start of fifirst study intervention, whichever is shorter.\n* Known active central nervous system (CNS) involvement by malignancy. Participants with prior CNS involvement from their malignancy must have completed effective treatment of their CNS disease with no symptoms of disease in the absence of steroid treatment and at least stable findings on relevant CNS imaging and no evidence of leptomeningeal disease for at least 4 weeks prior to study enrollment.\n* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 6 months prior to study enrollment.\n* Currently receiving or likely to require systemic immunosuppressive therapy (e.g., prednisone ≥5 mg daily) for any reason from start of first study intervention to Day 29 with the exception of corticosteroids as a premedication for chemotherapy side effects per institutional standard of care or as mandated by the protocol.\n* Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase.\n* Grade ≥2 peripheral neuropathy limiting instrumental activities of daily living.","18 Years",{"count":97,"type":20},113,[23],"This is a phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without paclitaxel and\u002For trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.",[101,102,103,104,105,106],"Non-Small Cell Lung Cancer","Colorectal Cancer","Breast Cancer","Ovarian Cancer","Endometrial Carcinoma","Head and Neck Squamous Cell Carcinoma",[108],"HNSCC, NSCLC, CRC","2026-04-03",{"date":111,"type":50},"2026-04-07",{"date":113,"type":50},"2025-11-04",{"date":115,"type":20},"2030-01",{"name":33,"class":56},5,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":15,"minAge":95,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},"100534640","phase-1-ft825ono-8250-an-off-the-shelf-her2-car-t-with-or-without-monoclonal-antibodies-in-advanced-solid-tumors-100534640","NCT06241456","FT825\u002FONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors","A Phase 1 Study of FT825\u002FONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors","Inclusion Criteria:\n\n* Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria\n* Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types\n* Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention\n* Anticipated life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Females who are pregnant or breastfeeding\n* Evidence of inadequate organ function\n* Clinically significant cardiovascular disease\n* Known active central nervous system (CNS) involvement by malignancy\n* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment\n* Active bacterial, fungal, or viral infections\n* Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product\n* History of (non-infectious) interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, current ILD\u002Fpneumonitis, or suspected ILD\u002Fpneumonitis that cannot be ruled out based on imaging at screening\n* Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase\n* Active or history of autoimmune disease or immune deficiency\n* Receipt of an allograft organ transplant",{"count":126,"type":20},351,[23],"This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.",[130],"Advanced Solid Tumor","2025-12-02",{"date":133,"type":50},"2025-12-09",{"date":135,"type":50},"2024-01-05",{"date":137,"type":20},"2044-05-01",{"name":33,"class":56},14,""]