Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-01 @ 5:29 AM
Study NCT ID:
NCT04596033
Status:
TERMINATED
Last Update Posted:
2022-07-15
First Post:
2020-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002295', 'term': 'Carcinoma, Transitional Cell'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D001005', 'term': 'Anus Neoplasms'}, {'id': 'D015266', 'term': 'Carcinoma, Merkel Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D001004', 'term': 'Anus Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D027601', 'term': 'Polyomavirus Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D018278', 'term': 'Carcinoma, Neuroendocrine'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'whyStopped': 'Business reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-13', 'studyFirstSubmitDate': '2020-09-30', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune cell phenotyping', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Classification of peripheral immune cells via flow cytometry'}, {'measure': 'Epitope Spread', 'timeFrame': '4 weeks after first GEN-011 infusion', 'description': 'Tumor mutations will be identified by gene sequencing at multiple timepoints, and comparing the differences in mutations over time'}, {'measure': 'Tumor infiltrating immune cell', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Quantitation and phenotyping of immune cells in proximity to tumor cells using immunohistochemistry'}], 'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Adverse events will be graded according to the NC Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0'}], 'secondaryOutcomes': [{'measure': 'T cell responses to GEN-011', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Antigen-specific immunogenicity assays'}, {'measure': 'Duration of response', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Measured by RECIST'}, {'measure': 'Progression-free survival', 'timeFrame': '2 years after first GEN-011 infusion', 'description': 'Length of time without disease progression'}, {'measure': 'Overall survival', 'timeFrame': 'From first GEN-011 infusion through study completion, at least 2 years', 'description': 'Length of time patient remains alive'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Personalized', 'Immunotherapy', 'Solid Tumor', 'Personal', 'Cell Therapy', 'Carcinoma', 'Melanoma', 'Lung', 'Bladder', 'Cancer', 'Kidney', 'Anal', 'Squamous', 'TiTAN', 'ATLAS', 'PLANET', 'TiTAN-1', 'Autologous', 'Neoantigen'], 'conditions': ['Melanoma', 'Non-small Cell Lung Cancer', 'Squamous Cell Carcinoma of Head and Neck', 'Urothelial Carcinoma', 'Renal Cell Carcinoma', 'Small-cell Lung Cancer', 'Cutaneous Squamous Cell Carcinoma', 'Anal Squamous Cell Carcinoma', 'Merkel Cell Carcinoma']}, 'descriptionModule': {'briefSummary': "TiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.", 'detailedDescription': "TiTAN-1 is an open-label, multicenter, first-in-human Phase 1 study of GEN-011 in patients with melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC, bladder, ureter, urethra, or renal pelvis), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), or anal squamous cell carcinoma (ASCC). Patients will be enrolled into one of 2 cohorts. One cohort will receive a multiple low dose (MLD) regimen of GEN-011 to be given without lymphodepletion, and a second cohort will receive a single high dose (SHD) regimen of GEN-011 after lymphodepletion. Regardless of cohort, each dose of GEN-011 will be followed by a course of interleukin-2 (IL-2) as costimulatory therapy.\n\nGEN-011 is an investigational, personalized neoantigen adoptive cell therapy (ACT) that is being developed by Genocea for the treatment of adult patients with advanced solid tumors. A proprietary tool developed by Genocea called ATLAS™ (Antigen Lead Acquisition System) will be used to identify true immunogenic neoantigens from each patient's tumor that are recognized by their own CD4 and/or CD8 T cells. ATLAS-identified neoantigens will be used to stimulate and select autologous T cells collected by apheresis to generate an adoptive cell product ex vivo."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consents to study procedures\n* Diagnosis of one of the following solid tumors: cutaneous melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), renal cell carcinoma (RCC), small cell lung cancer (SCLC), cutaneous squamous cell carcinoma (CSCC), anal squamous cell carcinoma (ASCC), merkel cell carcinoma (MCC).\n* Received, been intolerant of, or been ineligible to receive standard of care treatment regimen.\n* Measurable disease per RECIST criteria\n* Life expectancy \\> 6 months and ECOG status 0 or 1\n* Capacity to tolerate lymphodepletion (SHD group only) and IL-2 therapy\n* Tumor tissue available\n* Willing to use contraceptives for 90 days after receiving GEN-011, and not currently pregnant.\n* Adequate blood, liver, kidney, and lung function\n* Sufficient stimulatory neoantigens identified in ATLAS\n\nExclusion Criteria:\n\n* Receiving immunosuppressive medications\n* Serious ongoing viral, bacterial, or fungal infection\n* History of cardiac arrhythmias or significant heart block\n* History of leptomeningeal carcinomatosis\n* Active autoimmune disease\n* Portal vein thrombosis\n* Malignant disease other than those treated in this study\n* Receiving other investigational anti-cancer therapy\n* Prior stem cell or solid organ transplant\n* Primary immune deficiency disease\n* Significant ongoing toxicities from prior therapies\n* A history of allergic reaction to sulfur derivatives'}, 'identificationModule': {'nctId': 'NCT04596033', 'briefTitle': 'TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genocea Biosciences, Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety, Proliferation and Persistence of GEN-011, an Autologous Adoptive Cell Therapy Targeting Neoantigens in Solid Tumors', 'orgStudyIdInfo': {'id': 'GEN-011-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multiple Low Dose (MLD)', 'description': 'GEN-011 is administered by IV infusion at 4-week intervals, up to 5 doses maximum. Each dose is followed by IL-2 administration. MLD patients will not undergo lymphodepletion.', 'interventionNames': ['Biological: GEN-011', 'Drug: IL-2']}, {'type': 'EXPERIMENTAL', 'label': 'Single High Dose (SHD)', 'description': 'GEN-011 is administered as a single IV infusion at the maximum available cell yield, after the patient completes a fludarabine/cyclophosphamide lymphodepletion regimen. The single GEN-011 dose is followed by IL-2 administration.', 'interventionNames': ['Biological: GEN-011', 'Drug: IL-2', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'GEN-011', 'type': 'BIOLOGICAL', 'description': 'Personalized neoantigen adoptive cell therapy (ACT)', 'armGroupLabels': ['Multiple Low Dose (MLD)', 'Single High Dose (SHD)']}, {'name': 'IL-2', 'type': 'DRUG', 'otherNames': ['Interleukin-2'], 'description': 'Cytokine', 'armGroupLabels': ['Multiple Low Dose (MLD)', 'Single High Dose (SHD)']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Lymphodepletion drug', 'armGroupLabels': ['Single High Dose (SHD)']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Lymphodepletion drug', 'armGroupLabels': ['Single High Dose (SHD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'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': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute', '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}}], 'overallOfficials': [{'name': 'Thomas Davis, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genocea Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genocea Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}