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NCT06922266 | NOT YET RECRUITING | Carcinoma, Non-Small-Cell Lung

Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option
Sponsor:

San Raffaele Hospital

Information provided by (Responsible Party):

Chiara Maria Cattaneo

Brief Summary:

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.

Condition or disease

Carcinoma, Non-Small-Cell Lung

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
Estimated Enrollment : 20 participants
Official Title : Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2029-04-30
Estimated Study Completion Date : 2029-04-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option

Location Details

NCT06922266

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Locations

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