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

NCT ID: NCT07239544

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-10
• Study Completion Date: 2026-07-10

Brief Summary

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.

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.

Conditions

Lung Cancer (NSCLC)

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

observational study

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Soochow university

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

2025666

Identifier Type: -

Identifier Source: org_study_id