CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT03412877
Title field or adapter rule: {'original_value': 'A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:27.598769+00:00
Published At: 2026-10-30T00:00:00+00:00
Record Updated At: 2026-10-30
Source Retrieved At: 2026-10-31T22:19:00.066997+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Endocrine Tumors", "Non-Small Cell Lung Cancer", "Ovarian Cancer", "Breast Cancer", "Gastrointestinal/Genitourinary Cancers", "Neuroendocrine Tumors", "Multiple Myeloma"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-10-30", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT03412877"
protocolSection.identificationModule.officialTitle: "A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in Patients With Metastatic Cancer"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE2"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['1/iTCR', '2/iTCR + Pembro'], 'description': 'Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.', 'name': 'Cyclophosphamide', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/iTCR', '2/iTCR + Pembro'], 'description': 'Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.', 'name': 'Fludarabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/iTCR', '2/iTCR + Pembro'], 'description': 'Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses). Patients in Cohort 3 may receive 72,000 IU/kg IV.', 'name': 'Aldesleukin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['1/iTCR', '2/iTCR + Pembro'], 'description': 'Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).', 'name': 'Individual Patient TCR-Transduced PBL', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['2/iTCR + Pembro'], 'description': 'Arm 2: Pembrolizumab 2 mg/kg IV over approximately 30 minutes on Days -2, 21, 42, and 63.', 'name': 'Pembrolizumab (KEYTRUDA(R))', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

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