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| Name | Class |
|---|---|
| Fondazione Umberto Veronesi | OTHER |
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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.
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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-small cell lung cancer (NSCLC) patients | Adult subjects with diagnosis of non-small cell lung cancer (NSLC) that could undergo surgery or neo-adjuvant treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency and cytotoxic activity of patient-specific tumor-reactive T cells. | 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. | 1-30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of activation, differentiation, and exhaustion markers in generated T cell product. | 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. | 12-30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time required for T cell generation and functional assessment. | 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. | 18-30 months |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara M Cattaneo, PhD | Contact | +39022643 | 4712 | cattaneo.chiara@hsr.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara M Cattaneo, PhD | IRCCS Ospedale San Raffaele | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33285141 | Background | 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. | |
| 31562797 | Background | 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. |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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Tissue and blood samples.
| 25838374 | Background | 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. |
| 30100188 | Background | 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. |
| 31853056 | Background | 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. |
| 36593398 | Background | 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. |
| 37704741 | Background | 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. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |