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

San Donato Group (GSD)

Status: Not yet enrolling

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Other

Identifiers

NCT06922266

Chewbacca

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

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.