Lung Cancer (NSCLC)Phase 2NCT07202611
DC/NK Cell Therapy
A Phase 2 study testing In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer in people with Lung Cancer (NSCLC), run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
Trial summary
Primary Outcomes The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Dec 2022to 31 Dec 2025
- Phase
- Phase 2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligibility of Participants:
- o Diagnosed histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease).
- Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
- At Least One Measurable Lesion:
- o The measurable lesion must not undergo radiotherapy during the cell therapy period.
- Age:
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- o ≥20 years.
- Weight:
- o Between 40 and 100 kg.
- Normal Blood Count (based on test results within 4 weeks before blood collection for cell preparation):
- o White blood cells (WBC): ≥3000/mm³.
- o Lymphocytes: ≥1000/mm³.
- Hemoglobin: ≥10 g/dL.
- Platelets: ≥100,000/mm³.
- Normal Liver and Kidney Function (based on test results within 4 weeks before blood collection for cell preparation):
- Creatinine: ≤1.25× the upper limit of normal (ULN).
- Total bilirubin: ≤1.5× ULN.
- SGOT (AST): ≤3× ULN.
- SGPT (ALT): ≤3× ULN.
- Informed Consent:
- o Participants must sign the consent form.
- ECOG Performance Status:
- o Score of 0-1.
- For Women of Childbearing Age:
- Must agree to use effective contraception during the trial.
Who cannot join
- Positive Test Results for the Following Infections:
- o HCV (HCV antibody-positive).
- HBV (HBsAg-positive).
- HIV (HIV antibody-positive).
- HTLV (HTLV antibody-positive).
- Syphilis (Treponema pallidum antibody-positive).
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- Tuberculosis (TB culture-positive).
- ECOG Performance Status:
- o Score of 2-4.
- Albumin Intolerance:
- o Participants who cannot tolerate albumin.
- Short Life Expectancy:
- o Life expectancy estimated by the physician to be less than 12 weeks.
- Participation in Other Clinical Trials:
- o Within 30 days prior to entering this trial.
- Pregnancy or Breastfeeding:
- o Positive pregnancy test or currently breastfeeding.
- Other Medical Conditions:
- o Immunodeficiency, severe heart or lung dysfunction, coagulation disorders, unresolved side effects from prior cancer therapy (not recovered to CTCAE grade 1), prior transplant surgery, or deemed unsuitable by the physician.
- Noncompliance:
- o Unable to adhere to follow-up or examination procedures.
- Concurrent Cancer:
- o Other cancers diagnosed within the past 2 years.
- Specific Complications:
- Brain metastases, leptomeningeal disease, or spinal cord compression.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Huwei, YUNLIN, 640
Chung-Yu Chen, 055323911, c8101147@ms16.hinet.net
About this study
Official title: In Vitro Culture of Autologous Dendritic and Natural Killer Cells for the Treatment of Patients With Non-small Cell Lung Cancer
Primary Outcomes The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use.
Secondary Outcomes
Read more
To verify the success rate of the cultured cell formulations and assess the cytotoxic capacity of natural killer cells in targeting and killing tumor cells. The evaluation of these secondary objectives involves analyzing specific subcategories, which can be divided into two major components:
- Validation of Cultured Cell Preparation Success: Assessing the proliferation rate, recovery rate, survival rate, and tumor-killing capacity of the cultured autologous dendritic cells and natural killer cells.
- Validation of Antitumor Effectiveness: Evaluating the antitumor efficacy of the trial products administered via axillary lymph node injection of autologous dendritic cells and intravenous infusion of autologous natural killer cells.
Read the detailed description
Research Background and Current Status of Medical Technology According to data from the Ministry of Health, cancer has consistently ranked as the leading cause of death in Taiwan. Although various treatments for cancer, including surgery, chemotherapy, and radiotherapy, are currently available, there is still significant room for improvement in terms of extending survival and reducing side effects. Recently, research on natural killer (NK) cell therapy has gained attention both domestically and internationally. While the therapeutic effects remain uncertain and most countries are still in the clinical trial stage, preliminary results and studies from other countries suggest that combining NK cell therapy with traditional treatments like chemotherapy or radiotherapy may provide additional benefits for cancer patients.
Natural killer cells are among the first-line innate immune defenses in the human body and are considered one of the most potent and effective cells for combating cancer and viral infections. Compared to other anti-cancer immune cells, such as cytotoxic T cells or dendritic cells, NK cells exhibit stronger cytotoxicity, a broader spectrum of activity, and are not restricted by tissue compatibility antigens. They can directly attack cancer cells without the need for prior sensitization. Since the discovery of NK cells in the 1970s, immunologists have hypothesized that expanding NK cells in large quantities and reinfusing them into patients could achieve anti-cancer effects, enhance immune regulation, and improve overall immunity. This forms the theoretical basis of NK cell therapy.
In simple terms, NK cell therapy involves the use of cell culture techniques to rapidly proliferate a patient's NK cells in vitro and then reinject them into the patient. This approach aims to boost the patient's innate anti-cancer capacity and support conventional therapies in achieving cancer treatment goals.
Laboratory studies using animal models and in vitro experiments have highlighted several theoretical advantages of NK cell therapy for cancer treatment:
- NK cells exhibit the strongest anti-cancer activity in the human body, directly killing cancer cells and inhibiting tumor growth and spread.
- NK cells suppress the formation of new blood vessels around tumors, restricting the supply of nutrients necessary for tumor growth.
Although the clinical effectiveness of NK cell therapy for cancer in humans has yet to be confirmed, some preliminary international studies suggest that adding activated NK cells or cytokine-induced killer (CIK) cells to standard treatments may help inhibit the spread of cancer cells and slow disease progression.
Characteristics of Human Cell Therapy Products and Usage Experience
- Cell Source and Characteristics Source: Autologous cells Characteristics: Dendritic cells (DCs) have the ability to activate adaptive immune functions. NK cells possess tumor-killing capabilities. Rationale for Use in This Indication: Preliminary clinical studies indicate that in non-small cell lung cancer (NSCLC) patients, groups receiving NK cell (or NK + DC) immunotherapy in addition to traditional treatments (surgery, chemotherapy, or radiotherapy) showed better outcomes in individual trials compared to control groups that received only traditional treatments. These outcomes included improved objective response rates (ORR), progression-free survival (PFS), overall survival (OS), and, in some cases, enhanced quality of life (refer to the summary table on the next page for details).
- Usage Experience Numerous clinical trials have already been conducted internationally. The investigational drug in this trial is being tested in humans for the first time.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer
- Keywords
- lung cancer, cell therapy, NK cell, Dendritic cell
- 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.
In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancerBiological
The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use.
| Study group | Role | What they receive |
|---|---|---|
| In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with | Experimental | Not described Receives: Biological: In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Adverse Events Following Administration of Autologous Dendritic Cells (via Axillary Lymph Node Injection) and Natural Killer Cells (via Intravenous Injection) cultured in vitro
The primary objective of this trial is to evaluate the safety profile of in vitro-cultured dendritic cells (DCs) and natural killer (NK) cells. Specifically, the study will assess adverse reactions, including incidence, type, and severity of treatment-emergent adverse events, following administration of autologous DCs via axillary lymph node injection and NK cells via intravenous injection.
Measured: 12 weeks
Secondary outcomes (3)
Number of Participants with Successful Cultured Cell Preparation (Defined by ≥80% Cell Viability and Absence of Contamination)
Validation will be based on cell viability, sterility testing, and phenotypic confirmation. A successful preparation is defined as viability ≥80%, absence of bacterial/mycoplasma contamination, and retention of lineage-specific surface markers as assessed by flow cytometry.
Measured: 12 weeks
Validation of Antitumor Effectiveness (In Vitro)
Percentage of Tumor Cells Exhibiting Reduced Viability After Treatment (MTT Assay)
Measured: 12 weeks
Proportion of Participants with Tumor Response (Complete Response, Partial Response, or Stable Disease per RECIST v1.1)
Number of Participants with Treatment-Emergent Objective Tumor Regression (≥30% Reduction in Target Lesions per RECIST v1.1)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start2 Dec 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (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.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients who diagnosed as histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease), and have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Clinical Trial Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor-investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202611
- Sponsor's protocol ID
- 201904109MIFC
- Status last verified
- Sep 2025
- First submitted
- 7 Jan 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Culture of Autologous Dendritic and Natural Killer Cells for the Treatment of Patients With Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07202611
- Acronym / sponsor ID
- 201904109MIFC
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- lung cancer, cell therapy, NK cell, Dendritic cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University Clinical Trial CenterUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 2 Oct 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.
Primary Outcomes The primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use.
Secondary Outcomes
To verify the success rate of the cultured cell formulations and assess the cytotoxic capacity of natural killer cells in targeting and killing tumor cells. The evaluation of these secondary objectives involves analyzing specific subcategories, which can be divided into two major components:
- Validation of Cultured Cell Preparation Success: Assessing the proliferation rate, recovery rate, survival rate, and tumor-killing capacity of the cultured autologous dendritic cells and natural killer cells.
- Validation of Antitumor Effectiveness: Evaluating the antitumor efficacy of the trial products administered via axillary lymph node injection of autologous dendritic cells and intravenous infusion of autologous natural killer cells.
Detailed description
Research Background and Current Status of Medical Technology According to data from the Ministry of Health, cancer has consistently ranked as the leading cause of death in Taiwan. Although various treatments for cancer, including surgery, chemotherapy, and radiotherapy, are currently available, there is still significant room for improvement in terms of extending survival and reducing side effects. Recently, research on natural killer (NK) cell therapy has gained attention both domestically and internationally. While the therapeutic effects remain uncertain and most countries are still in the clinical trial stage, preliminary results and studies from other countries suggest that combining NK cell therapy with traditional treatments like chemotherapy or radiotherapy may provide additional benefits for cancer patients.
Natural killer cells are among the first-line innate immune defenses in the human body and are considered one of the most potent and effective cells for combating cancer and viral infections. Compared to other anti-cancer immune cells, such as cytotoxic T cells or dendritic cells, NK cells exhibit stronger cytotoxicity, a broader spectrum of activity, and are not restricted by tissue compatibility antigens. They can directly attack cancer cells without the need for prior sensitization. Since the discovery of NK cells in the 1970s, immunologists have hypothesized that expanding NK cells in large quantities and reinfusing them into patients could achieve anti-cancer effects, enhance immune regulation, and improve overall immunity. This forms the theoretical basis of NK cell therapy.
In simple terms, NK cell therapy involves the use of cell culture techniques to rapidly proliferate a patient's NK cells in vitro and then reinject them into the patient. This approach aims to boost the patient's innate anti-cancer capacity and support conventional therapies in achieving cancer treatment goals.
Laboratory studies using animal models and in vitro experiments have highlighted several theoretical advantages of NK cell therapy for cancer treatment:
- NK cells exhibit the strongest anti-cancer activity in the human body, directly killing cancer cells and inhibiting tumor growth and spread.
- NK cells suppress the formation of new blood vessels around tumors, restricting the supply of nutrients necessary for tumor growth.
Although the clinical effectiveness of NK cell therapy for cancer in humans has yet to be confirmed, some preliminary international studies suggest that adding activated NK cells or cytokine-induced killer (CIK) cells to standard treatments may help inhibit the spread of cancer cells and slow disease progression.
Characteristics of Human Cell Therapy Products and Usage Experience
- Cell Source and Characteristics Source: Autologous cells Characteristics: Dendritic cells (DCs) have the ability to activate adaptive immune functions. NK cells possess tumor-killing capabilities. Rationale for Use in This Indication: Preliminary clinical studies indicate that in non-small cell lung cancer (NSCLC) patients, groups receiving NK cell (or NK + DC) immunotherapy in addition to traditional treatments (surgery, chemotherapy, or radiotherapy) showed better outcomes in individual trials compared to control groups that received only traditional treatments. These outcomes included improved objective response rates (ORR), progression-free survival (PFS), overall survival (OS), and, in some cases, enhanced quality of life (refer to the summary table on the next page for details).
- Usage Experience Numerous clinical trials have already been conducted internationally. The investigational drug in this trial is being tested in humans for the first time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients who diagnosed as histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease), and have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted therapies.
| Arm | Type | Receives |
|---|---|---|
| In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with | Experimental | Biological: In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Eligibility of Participants:
- o Diagnosed histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients with recurrence or progression following multimodal treatments (radiotherapy, surgical resection, or therapeutic chemoradiotherapy for locally advanced disease).
- At Least One Measurable Lesion:
- o The measurable lesion must not undergo radiotherapy during the cell therapy period.
- Age:
Key exclusion criteria (25 listed)
- Positive Test Results for the Following Infections:
- o HCV (HCV antibody-positive).
- ECOG Performance Status:
- o Score of 2-4.
- Albumin Intolerance:
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 |
|---|---|---|
| In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancerThe primary objective of this trial is to test the safety of formulations containing dendritic cells (DCs) and natural killer (NK) cells cultured in vitro. By evaluating the reactions following the administration of autologous dendritic cells via axillary lymph node injection and natural killer cells via intravenous injection, the study aims to determine the safety profile of these trial products for human use. | Biological | In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with |
Primary outcome
Incidence and Severity of Adverse Events Following Administration of Autologous Dendritic Cells (via Axillary Lymph Node Injection) and Natural Killer Cells (via Intravenous Injection) cultured in vitro
Time frame: 12 weeks
The primary objective of this trial is to evaluate the safety profile of in vitro-cultured dendritic cells (DCs) and natural killer (NK) cells. Specifically, the study will assess adverse reactions, including incidence, type, and severity of treatment-emergent adverse events, following administration of autologous DCs via axillary lymph node injection and NK cells via intravenous injection.
3 secondary outcomes
Number of Participants with Successful Cultured Cell Preparation (Defined by ≥80% Cell Viability and Absence of Contamination)
Time frame: 12 weeks
Validation of Antitumor Effectiveness (In Vitro)
Time frame: 12 weeks
Proportion of Participants with Tumor Response (Complete Response, Partial Response, or Stable Disease per RECIST v1.1)
Time frame: 12 weeks
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 2 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing In vitro culture of autologous dendritic and natural killer cells for the treatment of patients with non-small cell lung cancer in people with Lung Cancer (NSCLC), run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
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 25 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Taiwan. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Chung-Yu Chen (886-5-5323911, c8101147@ms16.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Adverse Events Following Administration of Autologous Dendritic Cells (via Axillary Lymph Node Injection) and Natural Killer Cells (via Intravenous Injection) cultured in vitro (time frame: 12 weeks). 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 2 Oct 2025.