Status:

NOT_YET_RECRUITING

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

Lead Sponsor:

Ospedale San Raffaele

Collaborating Sponsors:

Fondazione Umberto Veronesi

Conditions:

Carcinoma, Non-Small-Cell Lung

Eligibility:

All Genders

18+ years

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.

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 2...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

May 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

April 30 2029

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06922266

Start Date

May 1 2025

End Date

April 30 2029

Last Update

April 10 2025

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