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NCT Number: NCT06922266

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara M Cattaneo, PhD

CONTACT

[email protected]

+39022643 ext. 4712

Sponsors and collaborators

Lead sponsor

Ospedale San Raffaele

Other

Collaborators

  • Fondazione Umberto Veronesi

Registry information

Acronym: Chewbacca

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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