Pulmonary Nodules, Multiple, Pulmonary Nodules, Solitary
Conditions
Brief summary
A single-center, open-label dose-escalation design to evaluate the safety and efficacy of KN5001 in patients with pulmonary nodules.
Interventions
BIOLOGICALKN5001
Subjects will receive KN5001 on day0, 3, and 6. Multiple Doses of KN5001 will infused using the 3 + 3 dose-escalation strategy.
Sponsors
Rui Therapeutics Co., Ltd
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily sign the informed consent form, understand this clinical study, and are willing to follow and able to complete all trial procedures; 2. 18-70 years old, male or female; 3. Subjects 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 nodules (refer to the standards in Appendix 12) cannot be surgically removed again, and are not suitable for other effective treatments or have failed other treatments; 4. 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.
Exclusion criteria
1. Subjects who are known to have allergic reactions, hypersensitivity reactions, intolerances or contraindications to any component of KN5001, or subjects with a history of severe allergic reactions; 2. Subjects with the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any known bone marrow failure syndrome; 3. Subjects with active or uncontrolled infections requiring parenteral antibiotics; Evidence of a serious active viral or bacterial infection or an uncontrolled systemic fungal infection; 4. Subjects with heart failure of grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standard (see Appendix 1); 5. Subjects with a history of epilepsy or other central nervous system diseases; 6. Subjects with a history of malignant tumors, excluding patients with cured skin or cervical carcinoma in situ and patients with inactive tumors; 7. Subjects with a significant bleeding tendency, such as gastrointestinal bleeding, coagulopathy, hypersplenism, etc.; 8. Subjects with unstable angina, symptomatic congestive heart failure, or myocardial infarction in the past 6 months; 9. Females who are pregnant, lactating, or planning a pregnancy within six months; 10. Subjects who have received other clinical trial treatment within 3 months; 11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of all adverse events occurring within 28 days after the first infusion of KN5001 | Time Frame: up to 28 days after infusion | To characterize the Treatment Emergent Adverse Events (TEAEs) of KN5001 for patients with pulmonary nodules |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The overall response rate (ORR) | Time Frame: 6 and 12 months after infusion | To characterize the efficacy of KN5001 for patients with pulmonary nodules |
| Disease control rate (DCR) | Time Frame: 6 and 12 months after infusion | To characterize the efficacy of KN5001 for patients with pulmonary nodules |
Countries
China
Contacts
Primary ContactYongqian Shu
Outcome results
None listed