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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2029-04-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No