Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT04135092
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-09-04
First Post:
2019-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'C024352', 'term': 'fludarabine'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'C582435', 'term': 'pembrolizumab'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2020-09', 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2019-10-21', 'studyFirstSubmitQcDate': '2019-10-21', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-22', 'type': 'ACTUAL'}}, 'descriptionModule': {'briefSummary': 'Single Patient Expanded Access', 'detailedDescription': 'Background:\n\nPlease refer to National Cancer Institute Surgery Branch (NCI-SB) protocol 18-C-0049, Amendment F.\n\nObjective:\n\nUnder Individual Patient Expanded Access, to treat a patient with metastatic prostate cancer with autologous peripheral blood lymphocytes (PBL) that have been transduced with genes encoding T-cell receptors that recognize the mutated TP53 shared oncogene in the autologous cancer.\n\nEligibility:\n\n* Must have measurable, metastatic disease as assessed per RECIST v1.1 criteria.\n* Must sign the informed consent document.\n* Willing to sign Durable Power of Attorney Form.\n* Must have all regulatory approvals prior to start of treatment.\n\nDesign:\n\n* Please refer to NCI-SB protocol 18-C-0049, Amendment F.\n* The patient will be treated with a non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine, followed by the infusion of autologous transduced PBL and then high-dose aldesleukin. The patient will also receive pembrolizumab on Day -2 prior to cell administration and additional doses every 3 weeks following cell infusion until the time of disease progression.'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Measurable (per RECIST v1.1 criteria), metastatic prostate cancer.\n* Refractory to approved standard systemic therapy.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a Durable Power of Attorney Form.\n* Willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n* Subject must be co-enrolled on protocol 03-C-0277.\n\nExclusion Criteria:\n\nNot applicable.'}, 'identificationModule': {'nctId': 'NCT04135092', 'briefTitle': 'Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Single Patient Protocol: A Phase II Study Using the Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in a Patient With Metastatic Cancer Plus the Administration of Pembrolizumab', 'orgStudyIdInfo': {'id': '209950'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Individual Patient TCR Transduced PBL', 'type': 'BIOLOGICAL', 'description': 'Day 0: Cells will be infused at a dose not to exceed .5e11 in 400 mL IV on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).'}, {'name': 'Cyclophosphamide', 'type': 'DRUG', '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': 'Fludarabine', 'type': 'DRUG', 'description': 'Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.'}, {'name': 'Aldesleukin', 'type': 'DRUG', 'description': 'Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses).'}, {'name': 'Pembrolizumab', 'type': 'DRUG', 'description': 'Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}