BridgeMD
Tests treatment safety and results for Pulmonary Nodules, Solitary
Official title An Exploratory Clinical Study on the Safety and Efficacy of Autologous NK Cells in the Treatment of Pulmonary Nodules
ClinicalTrials.gov ID: NCT07185035
What this study is testing
What is KN5001?
KN5001 is an investigational medicine, being studied as a potential treatment for pulmonary nodules, solitary.
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
- A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial...
- 18-70 years old, male or female;
- people with lung nodules confirmed by imaging examination must meet the following conditions: Multiple high-risk nodules have been surgically removed...
- If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging...
You likely can't join if
- people who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or people...
- people with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;
- people with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an...
- people with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see...
- people with a history of epilepsy or other central nervous system diseases;
- people with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;
See the full eligibility criteria
- people voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures;
- 18-70 years old, male or female;
- people with lung nodules confirmed by imaging examination must meet the following conditions: Multiple high-risk nodules have been surgically removed and confirmed to be malignant lesions, and the remaining high-risk...
- If the subject is unable to complete the puncture or the puncture fails, the subject must be diagnosed as a malignant nodule through PET-CT imaging examination.
- people who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or people with a history of severe allergic reactions;
- people with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome;
- people with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection;
- people with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1);
- people with a history of epilepsy or other central nervous system diseases;
- people with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors;
- people with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.;
- people with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months;
- Females who are pregnant, lactating, or planning a pregnancy within six months;
- people who have received other clinical trial treatment within 3 months;
- Any situation judged by the investigators that may increase the risk of the people or interfere with the clinical trial outcome.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, China
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, China. 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.