Clinical trial for Lung Cancer (NSCLC)
Official title DC/NK Cell Therapy
ClinicalTrials.gov ID: NCT07202611
What this study is testing
What is In vitro culture of autologous dendritic and natural killer cells?
This is an investigational biological treatment being studied for non-small cell lung cancer. It is designed to use your own immune cells, which are grown in a lab and then given back to you to help your body fight the cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if the treatment is safe and sees if the cells can kill tumor cells.
- Who it's for
- People with non-small cell lung cancer (NSCLC).
- What's involved
- Participants receive their own immune cells, grown in a lab, through an arm injection and an IV drip.
- Time commitment
- The source text does not specify the total duration or number of visits.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- Eligibility of Participants: o Diagnosed histologically or cytologically with stage IIIB or stage IV non-small cell lung cancer (NSCLC) or patients...
- Have undergone at least two systemic therapies for advanced NSCLC, including platinum-based chemotherapy, anti-PD-1 therapy, and/or other targeted...
- At Least One Measurable Lesion: o The measurable lesion must not undergo radiotherapy during the cell therapy period.
- Age: o ≥20 years.
- Weight: o Between 40 and 100 kg.
You likely can't join if
- 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).
- Tuberculosis (TB culture-positive).
See the full eligibility criteria
- 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...
- 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: 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.
- 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.
- Must agree to use effective contraception during the trial.
- 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).
- 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...
- Noncompliance: o Unable to adhere to follow-up or examination procedures.
- Concurrent Cancer: o Other cancers diagnosed within the past 2 years.
- Brain metastases, leptomeningeal disease, or spinal cord compression.
The study team makes the final eligibility decision.
Where it is enrolling
- Huwei, YUNLIN, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huwei, YUNLIN, Taiwan. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.