Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-29 @ 6:15 AM
Study NCT ID:
NCT06922266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-10
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue and blood samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'targetDuration': '4 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2025-03-26', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time required for T cell generation and functional assessment.', 'timeFrame': '18-30 months', 'description': 'The outcome will be evaluated by measuring the time (in days) required to generate tumor-reactive T cells and assessing their functionality through activation marker expression (e.g., CD137, CD107a) and cytotoxic activity via flow cytometry.'}], 'primaryOutcomes': [{'measure': 'Frequency and cytotoxic activity of patient-specific tumor-reactive T cells.', 'timeFrame': '1-30 months', 'description': 'The outcome will be evaluated by measuring the percentage of tumor-reactive T cells expressing activation markers (e.g., CD137, CD107a) via flow cytometry. Cytotoxic activity will be assessed through a tumor-killing assay, quantified as the percentage of tumor cell death measured by microscopy and flow cytometry.'}], 'secondaryOutcomes': [{'measure': 'Expression of activation, differentiation, and exhaustion markers in generated T cell product.', 'timeFrame': '12-30 months', 'description': 'The outcome will be evaluated by measuring the percentage of T cells expressing activation (e.g., CD137, CD107a), differentiation (e.g., CD45RA, CCR7), and exhaustion (e.g., PD-1, TIM-3) markers via flow cytometry.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Precision Oncology', 'Lung cancer', 'Adoptive Cell Transfer'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '33285141', 'type': 'BACKGROUND', 'citation': 'Meric-Bernstam F, Larkin J, Tabernero J, Bonini C. Enhancing anti-tumour efficacy with immunotherapy combinations. Lancet. 2021 Mar 13;397(10278):1010-1022. doi: 10.1016/S0140-6736(20)32598-8. Epub 2020 Dec 4.'}, {'pmid': '31562797', 'type': 'BACKGROUND', 'citation': 'Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Rutkowski P, Lao CD, Cowey CL, Schadendorf D, Wagstaff J, Dummer R, Ferrucci PF, Smylie M, Hogg D, Hill A, Marquez-Rodas I, Haanen J, Guidoboni M, Maio M, Schoffski P, Carlino MS, Lebbe C, McArthur G, Ascierto PA, Daniels GA, Long GV, Bastholt L, Rizzo JI, Balogh A, Moshyk A, Hodi FS, Wolchok JD. Five-Year Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma. N Engl J Med. 2019 Oct 17;381(16):1535-1546. doi: 10.1056/NEJMoa1910836. Epub 2019 Sep 28.'}, {'pmid': '25838374', 'type': 'BACKGROUND', 'citation': 'Rosenberg SA, Restifo NP. Adoptive cell transfer as personalized immunotherapy for human cancer. Science. 2015 Apr 3;348(6230):62-8. doi: 10.1126/science.aaa4967.'}, {'pmid': '30100188', 'type': 'BACKGROUND', 'citation': 'Dijkstra KK, Cattaneo CM, Weeber F, Chalabi M, van de Haar J, Fanchi LF, Slagter M, van der Velden DL, Kaing S, Kelderman S, van Rooij N, van Leerdam ME, Depla A, Smit EF, Hartemink KJ, de Groot R, Wolkers MC, Sachs N, Snaebjornsson P, Monkhorst K, Haanen J, Clevers H, Schumacher TN, Voest EE. Generation of Tumor-Reactive T Cells by Co-culture of Peripheral Blood Lymphocytes and Tumor Organoids. Cell. 2018 Sep 6;174(6):1586-1598.e12. doi: 10.1016/j.cell.2018.07.009. Epub 2018 Aug 9.'}, {'pmid': '31853056', 'type': 'BACKGROUND', 'citation': 'Cattaneo CM, Dijkstra KK, Fanchi LF, Kelderman S, Kaing S, van Rooij N, van den Brink S, Schumacher TN, Voest EE. Tumor organoid-T-cell coculture systems. Nat Protoc. 2020 Jan;15(1):15-39. doi: 10.1038/s41596-019-0232-9. Epub 2019 Dec 18.'}, {'pmid': '36593398', 'type': 'BACKGROUND', 'citation': 'Cattaneo CM, Battaglia T, Urbanus J, Moravec Z, Voogd R, de Groot R, Hartemink KJ, Haanen JBAG, Voest EE, Schumacher TN, Scheper W. Identification of patient-specific CD4+ and CD8+ T cell neoantigens through HLA-unbiased genetic screens. Nat Biotechnol. 2023 Jun;41(6):783-787. doi: 10.1038/s41587-022-01547-0. Epub 2023 Jan 2.'}, {'pmid': '37704741', 'type': 'BACKGROUND', 'citation': 'Cattaneo CM. Identification of personalized cancer neoantigens with HANSolo. Nat Rev Cancer. 2023 Dec;23(12):800. doi: 10.1038/s41568-023-00624-z. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This is a monocentric prospective observational study. This study will include patients with a diagnosis of non-small cell lung cancer for the collection of blood and tissue specimens.', 'detailedDescription': 'This study seeks to advance patient-specific cancer immunotherapy, through the ex-vivo generation of tumor-specific T cells recognizing and targeting tumor-specific mutations.\n\nThe study will enroll 20 adult patients with a diagnosis of non-small cell lung cancer, including those with lymph node involvement. Biological samples, including tumor and healthy lung tissue, as well as peripheral blood, will be collected pre-surgery and pre-treatment. The establishment of this sample collection will enable the detailed study of tumor-specific immune responses in non-small cell lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population includes adult patients diagnosed with non-small cell lung cancer. Individuals of diverse gender, age, and ethnicity will be included, specifically those with stage I-II and III non-small cell lung cancer, including cases with lymph node involvement.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to provide informed consent for participation in the study.\n* Age: Adults aged 18 years or older.\n* Diagnosis: non-small cell lung cancer (Stage I-II, III), with or without lymph node involvement, ideally with sufficient tumor burden to provide adequate tissue for analysis. In accordance with good clinical practice, patients with early-stage disease will undergo direct surgery, whereas patients with advanced-stage disease will receive neoadjuvant treatment followed by surgery.\n* Ability to attend scheduled follow-up visits, if applicable, for additional peripheral blood sample collection during treatment.\n\nExclusion Criteria:\n\n* Presence of any active infection or underlying condition that could compromise the safety of tissue and blood sampling.\n* Prior history of another malignancy that might interfere with data interpretation related to non-small cell lung cancer progression and immune response.\n* Any current use of immunosuppressive medications (e.g., high-dose steroids) which might alter immune response assessments, except as part of non-small cell lung cancer treatment.\n* Pregnancy and breastfeeding'}, 'identificationModule': {'nctId': 'NCT06922266', 'acronym': 'Chewbacca', 'briefTitle': 'Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale San Raffaele'}, 'officialTitle': 'Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option', 'orgStudyIdInfo': {'id': 'Chewbacca'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-small cell lung cancer (NSCLC) patients', 'description': 'Adult subjects with diagnosis of non-small cell lung cancer (NSLC) that could undergo surgery or neo-adjuvant treatment.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Chiara M Cattaneo, PhD', 'role': 'CONTACT', 'email': 'cattaneo.chiara@hsr.it', 'phone': '+39022643', 'phoneExt': '4712'}], 'overallOfficials': [{'name': 'Chiara M Cattaneo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Ospedale San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione Umberto Veronesi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Chiara Maria Cattaneo', 'investigatorAffiliation': 'Ospedale San Raffaele'}}}}