Lung Cancer (NSCLC)NCT07239544
Generation of Reactive T Cells Based on Tumor Whole Cell Antigen Nanovaccines
An observational study of Lung Cancer (NSCLC), run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- observational study
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2025to 10 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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.
Who cannot join
- a.History of active autoimmune diseases: such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., to avoid vaccine-induced immune storm.
- Previous immunotherapy: including PD-1/L1 inhibitors, CTLA-4 inhibitors, cancer vaccines, or other cellular therapies within 6 months, with treatment interference excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- observational study
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Jul 2025
- Primary completion10 Jul 2026 (estimated)
- Study completion10 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07239544
- Sponsor's protocol ID
- 2025666
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generation of Tumor-reactive T Cells Based on Tumor Whole Cell Antigen Nanovaccines
- ClinicalTrials.gov ID
- NCT07239544
- Acronym / sponsor ID
- 2025666
- Conditions
- Lung Cancer (NSCLC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 10 Jul 2026 (estimated)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- a.History of active autoimmune diseases: such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., to avoid vaccine-induced immune storm.
- Previous immunotherapy: including PD-1/L1 inhibitors, CTLA-4 inhibitors, cancer vaccines, or other cellular therapies within 6 months, with treatment interference excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational 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 | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer (NSCLC), run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor reactive cells (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.