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

November 16, 2025 updated by: The First Affiliated Hospital of Soochow University

Generation of Tumor-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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patient private information is kept confidential and shall not be disclosed publicly. The patient information is for research purposes only and shall not be used for any commercial purpose.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 10, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 20, 2025

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025666

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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