Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT06241456
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2024-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C042382', 'term': 'fludarabine phosphate'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 351}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2044-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2024-01-27', 'studyFirstSubmitQcDate': '2024-01-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose limiting toxicities (DLTs)', 'timeFrame': 'Up to approximately 29 days', 'description': 'The number of participants with DLTs will be reported.'}, {'measure': 'Number of participants with treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to approximately 2 years', 'description': 'The number of participants with TEAEs will be reported.'}, {'measure': 'Severity of AEs', 'timeFrame': 'Up to approximately 2 years', 'description': 'Severity of AEs will be determined according to appropriate rating scales for the type of event reported.'}], 'secondaryOutcomes': [{'measure': 'Investigator-Assessed Overall Response Rate (ORR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1).'}, {'measure': 'Investigator-Assessed Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS defined as the time from first dose of study intervention to death from any cause.'}, {'measure': 'Plasma Concentration of FT825', 'timeFrame': 'At designated time points up to approximately 56 days', 'description': 'The plasma concentration of FT825 will be determined.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis 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'}, 'identificationModule': {'nctId': 'NCT06241456', 'briefTitle': 'FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fate Therapeutics'}, 'officialTitle': 'A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'FT825-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen A: FT825', 'description': 'Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).', 'interventionNames': ['Drug: FT825', 'Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Bendamustine', 'Drug: Docetaxel', 'Drug: Cisplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen B: FT825 + Cetuximab', 'description': 'Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).', 'interventionNames': ['Drug: FT825', 'Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Drug: Bendamustine', 'Drug: Docetaxel', 'Drug: Cisplatin', 'Drug: Cetuximab']}], 'interventions': [{'name': 'FT825', 'type': 'DRUG', 'otherNames': ['ONO-8250'], 'description': 'FT825 will be administered as an intravenous (IV) infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Fludarabine', 'type': 'DRUG', 'otherNames': ['FLUDARA'], 'description': 'Fludarabine will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Bendamustine', 'type': 'DRUG', 'description': 'Bendamustine will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Docetaxel will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen A: FT825', 'Regimen B: FT825 + Cetuximab']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Cetuximab will be administered as an IV infusion at planned dose levels.', 'armGroupLabels': ['Regimen B: FT825 + Cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of California San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale New Haven Hospital - Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Minnesota Medical School', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oncology Hematology Care Clinial Trials', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Ohio State University - Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'OU Health Stephenson Cancer Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University, Sidney Kimmel Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute (SCRI) - Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Fate Trial Disclosure', 'role': 'CONTACT', 'email': 'FateTrialDisclosure@fatetherapeutics.com', 'phone': '858-875-1800'}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Fate Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fate Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}