Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05274451
Status:
TERMINATED
Last Update Posted:
2025-07-01
First Post:
2022-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Investigate LYL797 in Adults With Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, open-label, dose-escalation and -expansion study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'Pipeline Reprioritization', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-27', 'studyFirstSubmitDate': '2022-02-18', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate incidence of dose-limiting toxicities (DLTs)', 'timeFrame': 'Up to 28 days', 'description': 'Incidence of dose-limiting toxicities (DLTs)'}, {'measure': 'Evaluate incidence of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years', 'description': 'Incidence of treatment-emergent adverse events (TEAEs)'}, {'measure': 'Evaluate severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 2 years', 'description': 'Severity of treatment-emergent adverse events (TEAEs)'}, {'measure': 'Determine recommended Phase 2 Dose (RP2D)', 'timeFrame': 'Up to 2 years', 'description': 'Dose-escalation phase to determine the recommended Phase 2 dose'}], 'secondaryOutcomes': [{'measure': 'Evaluate anti-tumor activity of LYL797 based on overall response rate (ORR) by RECIST, version 1.1', 'timeFrame': 'Up to 2 years', 'description': 'Overall response rate (ORR) by RECIST, version 1.1'}, {'measure': 'Evaluate duration of response (DOR)', 'timeFrame': 'Up to 2 years', 'description': 'Duration of response (DOR)'}, {'measure': 'Evaluate progression-free survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'Progression-free survival (PFS)'}, {'measure': 'Evaluate overall survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'Overall Survival (OS)'}, {'measure': 'Evaluate maximum concentration of LYL797 (Cmax) of LYL797 in peripheral blood (PB) samples', 'timeFrame': 'Up to 2 years', 'description': 'Maximum concentration of LYL797 (Cmax)'}, {'measure': 'Evaluate time to Cmax (Tmax) of LYL797 in peripheral blood (PB) samples', 'timeFrame': 'Up to 2 years', 'description': 'Time to Cmax (Tmax)'}, {'measure': 'Evaluate area under the concentration-time curve (AUC) of LYL797 in the peripheral blood (PB)', 'timeFrame': 'Up to 2 years', 'description': 'Area under the concentration-time curve (AUC)'}, {'measure': 'Evaluate Persistence of LYL797 CAR T cells in peripheral blood samples', 'timeFrame': 'Up to 2 years', 'description': 'Time to last detectable LYL797, Tlast'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR T-cell therapy', 'CAR T', 'CAR T-cell', 'CAR-T', 'CAR-T cell therapy', 'CAR-T cell', 'ROR1', 'ROR1+', 'ROR1 positive', 'cell therapy', 'immunotherapy', 'relapsed', 'refractory', 'solid tumor', 'advanced', 'metastatic', 'breast cancer', 'lung cancer', 'triple negative breast cancer', 'non small cell lung cancer', 'ovarian cancer', 'endometrial cancer'], 'conditions': ['Triple Negative Breast Cancer', 'TNBC - Triple-Negative Breast Cancer', 'Non-small Cell Lung Cancer', 'Non Small Cell Lung Cancer', 'Non Small Cell Lung Cancer Metastatic', 'Non-Small Cell Carcinoma of Lung, TNM Stage 4', 'Advanced Breast Cancer', 'Advanced Lung Carcinoma', 'NSCLC', 'NSCLC, Recurrent', 'NSCLC Stage IV', 'Relapsed Cancer', 'Relapse/Recurrence', 'Recurrent Breast Cancer', 'Recurrent NSCLC', 'Platinum-resistant Ovarian Cancer', 'Ovarian Cancer', 'Primary Peritoneal Carcinoma', 'Fallopian Tube Cancer', 'Endometrial Cancer', 'Endometrioid Tumor', 'High Grade Serous Carcinoma', 'Ovarian Epithelial Cancer']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and tolerability of LYL797, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ relapsed or refractory triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer (Ovarian cancer), or Endometrial cancer. The first part of the study will determine the safe dose for the next part of the study, and will enroll patients with TNBC, NSCLC, Ovarian or Endometrial cancer. The second part of the study will test that dose in additional patients with TNBC, NSCLC, Ovarian or Endometrial cancer.', 'detailedDescription': 'This Phase 1, single-arm, open-label, multi-center, dose-escalation and expansion study will evaluate the safety and tolerability of LYL797, ROR1- targeted CAR T cells, in adults with relapsed and/or refractory ROR1+ triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), Ovarian cancer, or endometrial cancer. The dose-escalation phase includes patients with TNBC, NSCLC, Ovarian, or Endometrial cancer, and will investigate multiple dose levels to identify the recommended Phase 2 dose (RP2D). The dose-expansion phase will enroll patients with TNBC, NSCLC, Ovarian, or Endometrial cancer at the RP2D.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'IInclusion Criteria:\n\n* ≥ 18 years of age at time of informed consent\n* Confirmation of ROR1 expression from a pretreatment tumor sample\n* Histologically confirmed TNBC or NSCLC that is relapsed or refractory, metastatic or locally advanced and unresectable\n* Platinum-resistant epithelial ovarian cancer/ fallopian tube cancer/ primary peritoneal cancer.\n* Endometrial cancer.\n* Measurable disease including a target lesion and an additional lesion for biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ and marrow function\n* Women of childbearing potential must have a negative pregnancy test at screening\n* All participants must agree to practice highly effective methods of contraception\n\nExclusion Criteria:\n\n* Prior treatment with any adoptive T-cell therapy or other anti-ROR1 therapy\n* Prior solid organ transplantation\n* Active, untreated brain metastasis or leptomeningeal disease; however, stable, treated brain metastases are allowed\n* Untreated or active infection at the time of screening or leukapheresis\n* HIV-positive, HTLV-1-positive, active acute HAV, acute or chronic HBV or HCV, or active tuberculosis\n* Impaired cardiac function or clinically significant cardiac disease\n* Uncontrolled pleural effusion, pericardial effusion, ascites requiring recurrent drainage procedures (once monthly or more frequent), or lymphangitis carcinomatosis\n* History of interstitial pneumonitis or pulmonary fibrosis.\n* Systemic corticosteroids or other immunosuppressive medications within 14 days of leukapheresis\n* Pregnant or lactating/nursing women'}, 'identificationModule': {'nctId': 'NCT05274451', 'briefTitle': 'A Study to Investigate LYL797 in Adults With Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lyell Immunopharma, Inc.'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies', 'orgStudyIdInfo': {'id': 'LYL797-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental LYL797', 'description': 'ROR1-targeted CAR T cells', 'interventionNames': ['Biological: LYL797']}], 'interventions': [{'name': 'LYL797', 'type': 'BIOLOGICAL', 'description': 'LYL797 is an autologous, genetically (Gen-R™) and epigenetically (Epi-R™) reprogrammed ROR1-targeted chimeric antigen receptor (CAR) T-cell therapy', 'armGroupLabels': ['Experimental LYL797']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University Hospital', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Cancer Center, Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute and Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Froedtert Hospital, Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Jackie Walling, MBChB, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lyell Immunopharma, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lyell Immunopharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}