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NCT Number: NCT07239544

Generation of Reactive T Cells Based on Tumor Whole Cell Antigen Nanovaccines

Tumor-reactive T cells are generated based on the tumor full antigen nanovaccine and the tumor-reactive T cells are reinjected for autologous therapy to provide the optimal treatment plan for clinical patients.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Soochow university

Suzhou, Jiangsu, 215000, China

About this study

To evaluate the anti-tumor effect of tumor-reactive T cells in human-derived 3D lung cancer organoids, and analyze the in vivo migration location, tumor infiltration characteristics and survival kinetics of reinjected tumor-reactive T cells to clarify their role in biotherapy and transformation potential.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • a.Freshly frozen tumor tissue samples of at least 0.5cm*0.5cm in length and diameter were obtained from patients with histologically confirmed primary non-small cell lung cancer (NSCLC) who underwent surgical resection.

b. HLA typing must match the preselected subtypes: prioritize common subtypes such as HLA-A*0201 and HLA-A*2402 to ensure standardized subsequent T-cell response evaluation.

Exclusion criteria

  • a.History of active autoimmune diseases: such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., to avoid vaccine-induced immune storm.

b. Previous immunotherapy: including PD-1/L1 inhibitors, CTLA-4 inhibitors, cancer vaccines, or other cellular therapies within 6 months, with treatment interference excluded.

Treatment and study plan

observational study

Other

observational study:Evaluate the broad-spectrum coverage of xenogeneic hybrid lung cancer antigens (including patient tissues and cell lines), and develop a universal whole-cell antigen nanodelivery system to replace autologous tumor-derived preparation

Primary outcomes

  1. Tumor reactive cells

    Time frame: 6 month

    To evaluate the antitumor effects of tumor-reactive T cells in human 3D lung cancer organoids, and to elucidate the in vivo migration and localization, tumor infiltration characteristics, and survival dynamics of reinfused tumor-reactive T cells, thereby clarifying their role and translational potential in biological therapy.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Registry information

Official study title

Generation of Tumor-reactive T Cells Based on Tumor Whole Cell Antigen Nanovaccines

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 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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