NCT07239544

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 10, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 16, 2025

Last Update Submit

November 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Tumor reactive cells

    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

Interventions

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

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soochow university

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Observation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2025

First Posted

November 20, 2025

Study Start

July 10, 2025

Primary Completion (Estimated)

July 10, 2026

Study Completion (Estimated)

July 10, 2026

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations