Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option (Chewbacca)
April 3, 2025 updated by: Chiara Maria Cattaneo, Ospedale San Raffaele
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.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chiara M Cattaneo, PhD
- Phone Number: 4712 +39022643
- Email: cattaneo.chiara@hsr.it
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Participant is willing and able to provide informed consent for participation in the study.
- Age: Adults aged 18 years or older.
- 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.
- Ability to attend scheduled follow-up visits, if applicable, for additional peripheral blood sample collection during treatment.
Exclusion Criteria:
- Presence of any active infection or underlying condition that could compromise the safety of tissue and blood sampling.
- Prior history of another malignancy that might interfere with data interpretation related to non-small cell lung cancer progression and immune response.
- 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.
- Pregnancy and breastfeeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency and cytotoxic activity of patient-specific tumor-reactive T cells.
Time Frame: 1-30 months
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Expression of activation, differentiation, and exhaustion markers in generated T cell product.
Time Frame: 12-30 months
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time required for T cell generation and functional assessment.
Time Frame: 18-30 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Chiara M Cattaneo, PhD, IRCCS Ospedale San Raffaele
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2025
Primary Completion (Estimated)
April 30, 2029
Study Completion (Estimated)
April 30, 2029
Study Registration Dates
First Submitted
March 26, 2025
First Submitted That Met QC Criteria
April 3, 2025
First Posted (Actual)
April 10, 2025
Study Record Updates
Last Update Posted (Actual)
April 10, 2025
Last Update Submitted That Met QC Criteria
April 3, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chewbacca
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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