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New treatment option for Non-small Cell Lung Cancer
Official title Allogeneic PB103 (NK Cells) Therapy in Non-small Cell Lung Cancer (NSCLC) Patients
ClinicalTrials.gov ID: NCT04616209
What this study is testing
What is donor-derived NK cell infusion?
donor-derived NK cell infusion is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung 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
- Objectives: To determine the safety, tolerability, and efficacy of allogeneic PB103 in patients with IIIb/IV or refractory non-small-cell lung cancer
- 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 to 70
You may be able to join if
- Recipient:
- Recipients (people) are between 20-70 years of age.
- Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
- Signed informed consent.
- people with histologically or cytologically confirmed non -small-cell lung cancer of stage IIIB-IV, not amenable to definitive multi-modality...
You likely can't join if
- Recipient:
- Patients with history of clinically significant interstitial lung disease or radiation pneumonitis.
- Patients with brain metastases or leptomeningeal disease.
- Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least...
- Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal, or intra-pelvic) within two weeks prior to starting study drug or who...
- Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTCAE (version 5.0) are not eligible but WBC and...
See the full eligibility criteria
- Recipient:
- Recipients (people) are between 20-70 years of age.
- Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
- Signed informed consent.
- people with histologically or cytologically confirmed non -small-cell lung cancer of stage IIIB-IV, not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease...
- people must have measurable or evaluable disease according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Lifespan over 6 months.
- Acceptable organ function, as evidenced by the following laboratory data: （a） Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN). (for patients with known hepatic...
- Donors are between 20-65 years of age.
- Related donor: 6/6 matched at HLA-A, -B and -DRb1 or haploidentical donor ≥ 4/8 match at HLA-A, -B, -C and -DRb1
- Signed informed consent.
- Recipient:
- Patients with history of clinically significant interstitial lung disease or radiation pneumonitis.
- Patients with brain metastases or leptomeningeal disease.
- Patients who have had radiation to the lung fields within four weeks of starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting to treatment.
- Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal, or intra-pelvic) within two weeks prior to starting study drug or who have not recovered from side effects of such procedure. Video-assisted...
- Patients who received anti-cancer treatment and did not recover from toxicities to grades 0-1 by NCI CTCAE (version 5.0) are not eligible but WBC and Hgb Grade 2 is acceptable.
- Patients with a second, clinically active, cancer. Patients with second cancers that have been treated with curative intent and/or are currently inactive are allowed.
- Known history of human immunodeficiency virus (HIV) seropositivity.
- Participants who are receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least one week or five half-lives, whichever is longer...
- Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use, except those on topical or inhaled steroids, or steroids are given via local injection.
- Patients with clinically significant, uncontrolled cardiovascular disease, such as unstable angina or myocardial infarction within 6 months prior to screening, abnormal left ventricular ejection fraction (LVEF \<50%)...
- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management.
- Pregnancy and lactating women.
- Other situations the investigators think not eligible for participation in the research. Donor
- Donors who are pregnant and lactating women.
- Donor who has had advanced tumor diseases.
- Donor who has had autoimmune diseases.
- Donors are positive for one of human immunodeficiency virus (HIV), syphilis serology test (RPR+TPHA), CMV IgM, human T-lymphotropic virus (HTLV), and hepatitis B and C virus.
- Other situations the investigators think not eligible for participation in the research.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, 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 - 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.