NSCLCEarly Phase 1NCT06097962
Safety and Efficacy of NK510 to Treat NSCLC
A Early Phase 1 study testing NK510, Tislelizumab，atezolizumab or sugemalimab and systemic therapy as selected by the investigator in people with NSCLC, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- NK510, Tislelizumab，atezolizumab or sugemalimab and systemic therapy as selected by the investigator
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Jul 2028
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, male or female.
- For dose expansion group (Group A/B/C):
- EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC.
- Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy.
- For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.
- At least one CT or MRI measurable lesion according to RECIST v1.1.
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- ECOG performance status 0-2.
- Expected survival ≥3 months.
- All toxicities from previous anti-tumor therapy (except alopecia and fatigue) resolved to grade 1 (CTCAE v5.0) or baseline; subjects with long-term sequelae from previous therapy (e.g., neuropathy after platinum-based therapy) are acceptable.
- Fertile females must be non-lactating and have a negative serum pregnancy test within 1 week before enrollment; all subjects (male or female) must agree to use contraception from signing informed consent until 6 months after the last NK510 infusion.
- Able to comply with the study protocol and follow-up procedures.
- Voluntarily sign the informed consent form.
Who cannot join
- Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment [e.g., vitiligo, psoriasis, alopecia] or diseases not expected to recur without external triggers).
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval >480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) <50%; clinically uncontrolled hypertension.
- Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.
- Systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive/immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation or topical corticosteroids are allowed in subjects without active autoimmune diseases.
- Known allergy or intolerance to PD-(L)1 blockade.
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- Meeting any of the following laboratory criteria:
- Hematology: Neutrophils <1.5×10⁹/L; Platelets <75×10⁹/L; Hemoglobin <90 g/L.
- Liver function: ALT >3×ULN (≥5×ULN in patients with liver metastasis); AST >3×ULN (≥5×ULN in patients with liver metastasis); TBIL >1.5×ULN or >2.5×ULN (3.0 mg/dL) in patients with Gilbert syndrome.
- Renal function: Serum creatinine >1.5×ULN or creatinine clearance <50 mL/min.
- Any other severe or uncontrollable medical diseases, active infections, physical examination abnormalities, laboratory test abnormalities, mental status changes or mental illnesses that increase subject risk or affect study results (assessed by investigator).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jinling hospital, affiliated to Medical school Nanjing University
Nanjing, Jiangsu
Tangfeng Lv, +86 139 5201 6932, bairoushui@163.com
About this study
Official title: First-in-Human Phase I Study of TIGIT-Blocked NK510 Cells in Patients With PD-1 Refractory Advanced NSCLC
This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.
- Conditions
- NSCLC
- Being tested
- NK510, Tislelizumab，atezolizumab or sugemalimab, systemic therapy as selected by the investigator
- Keywords
- Malignant Pleural Effusion
- Medical subject headings
- Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK510Drug
Intravenous infusion
Tislelizumab，atezolizumab or sugemalimabDrug
Administer according to the instructions
NK510Drug
intrapleural infusion
systemic therapy as selected by the investigatorDrug
Administer according to the instructions
| Study group | Role | What they receive |
|---|---|---|
| Group A (low-dose group) | Experimental | NK510 will be administered once a week for a total of six weeks.3×10^9 NK cells/dose.
PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator. Receives: Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab |
| Group B (medium-dose group) | Experimental | NK510 will be administered once a week for a total of six weeks.9×10^9 NK cells/dose.
PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.. Receives: Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab |
| Group C (high-dose group) | Experimental | NK510 will be administered once a week for a total of six weeks.12×10^9 NK cells/dose.
PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.. Receives: Drug: NK510; Drug: Tislelizumab，atezolizumab or sugemalimab |
| Group D1 (low-dose group) | Experimental | Thoracic perfusion therapy will be conducted on Days 1, 5, 9 and 13, for a total of 4 infusions, with 3×10⁹ NK510 cells/dose for each time via intrapleural infusion, for 2 consecutive cycles. This is a single-treatment-cycle study. Receives: Drug: NK510; Drug: systemic therapy as selected by the investigator |
| Group D2 (high-dose group) | Experimental | Thoracic perfusion therapy will be conducted on Days 1, 5, 9 and 13, for a total of 4 infusions, with 6×10⁹ NK510 cells/dose for each time via intrapleural infusion, for 2 consecutive cycles. This is a single-treatment-cycle study. Receives: Drug: NK510; Drug: systemic therapy as selected by the investigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity and incidence of adverse events
To evaluate DLT and the incidence of AEs associated with NK510 treatment
Measured: 6 weeks
Objective Response Rate
For intravenous groups: Proportion of subjects achieving CR and PR according to RECIST v1.1 after first NK510 administration; For pleural perfusion groups: Proportion of subjects achieving CR and PR according to WHO criteria after first NK510 intrapleural perfusion.
Measured: 6 weeks
Secondary outcomes (6)
Progression-Free Survival
Time from first NK510 administration to disease progression or death.
Measured: From the date of the first dose of NK510 until disease progression, death, or a maximum of 24 months after the first dose, whichever occurs first.
Puncture-Free Survival
Time from last treatment puncture to next puncture drainage (for pleural perfusion groups).
Measured: From the date of the last treatment puncture to the date of the next puncture drainage, or up to a maximum of 24 months after the last treatment puncture, whichever occurs first.
Duration of Response
Time from achievement of response to disease progression.
Measured: From the date of first documentation of objective response to disease progression, death, or a maximum of 24 months after the date of first response, whichever occurs first.
Disease Control Rate
Proportion of subjects achieving CR, PR or SD based on baseline tumor assessment.
Measured: From baseline tumor assessment up to the earliest of disease progression，or a maximum of 24 months after baseline.
Overall Survival
Time from screening enrollment to death.
Measured: From the date of screening enrollment to death, or a maximum of 24 months after screening enrollment, whichever occurs first.
Health-Related Quality of Life
Assessed by EORTC QLQ-C30 (V3.0) scale.
Measured: At screening, every 6 weeks during treatment, at study completion, or up to a maximum of 24 months after the first dose, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jinling Hospital, China
- Responsible party
- Sponsor
- Investigators
- Tangfeng Lv, PhD, Principal investigator, Jinling hospital, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097962
- Sponsor's protocol ID
- NK510-06
- Status last verified
- Aug 2026
- First submitted
- 17 Oct 2023
- Last updated
- 9 Sep 2026
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human Phase I Study of TIGIT-Blocked NK510 Cells in Patients With PD-1 Refractory Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06097962
- Acronym / sponsor ID
- NK510-06
- Conditions
- NSCLC
- Keywords
- Malignant Pleural Effusion
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Base Therapeutics (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jinling Hospital, China
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 24 Oct 2023 (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.
This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Dose escalation study
| Arm | Type | Receives |
|---|---|---|
| Group A (low-dose group) | Experimental | Drug: NK510, Drug: Tislelizumab，atezolizumab or sugemalimabNK510 will be administered once a week for a total of six weeks.3×10^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator. |
| Group B (medium-dose group) | Experimental | Drug: NK510, Drug: Tislelizumab，atezolizumab or sugemalimabNK510 will be administered once a week for a total of six weeks.9×10^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.. |
| Group C (high-dose group) | Experimental | Drug: NK510, Drug: Tislelizumab，atezolizumab or sugemalimabNK510 will be administered once a week for a total of six weeks.12×10^9 NK cells/dose. PD-1 blockade will be administered every 1 or 3 weeks, depending on PD-1 blockade chosed by investigator.. |
| Group D1 (low-dose group) | Experimental | Drug: NK510, Drug: systemic therapy as selected by the investigatorThoracic perfusion therapy will be conducted on Days 1, 5, 9 and 13, for a total of 4 infusions, with 3×10⁹ NK510 cells/dose for each time via intrapleural infusion, for 2 consecutive cycles. This is a single-treatment-cycle study. |
| Group D2 (high-dose group) | Experimental | Drug: NK510, Drug: systemic therapy as selected by the investigatorThoracic perfusion therapy will be conducted on Days 1, 5, 9 and 13, for a total of 4 infusions, with 6×10⁹ NK510 cells/dose for each time via intrapleural infusion, for 2 consecutive cycles. This is a single-treatment-cycle study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years, male or female.
- For dose expansion group (Group A/B/C):
- EGFR mutation-negative, ROS1-negative, and ALK-negative; unresectable and non-radiotherapeutic stage III or IV, locally advanced, recurrent or metastatic NSCLC.
- Disease progression after ≥4 courses of PD-(L)1 blockade ± chemotherapy.
- For pleural perfusion group (Group D1/D2): Advanced NSCLC with malignant pleural effusion ≥500ml (confirmed by B-ultrasound or CT); patients with driver gene-positive and resistant to targeted therapy are acceptable.
Key exclusion criteria (11 listed)
- Symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Active, known or suspected autoimmune diseases (excluding type 1 diabetes, hypothyroidism requiring only hormone replacement therapy, skin diseases not requiring systemic treatment [e.g., vitiligo, psoriasis, alopecia] or diseases not expected to recur without external triggers).
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe cardiac arrhythmia or conduction abnormalities requiring clinical intervention (e.g., ventricular arrhythmia, grade III atrioventricular block); QTc interval >480 ms on 12-lead ECG at rest; acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other grade ≥3 cardiovascular and cerebrovascular events within 6 months before enrollment; NYHA cardiac function class ≥II or left ventricular ejection fraction (LVEF) <50%; clinically uncontrolled hypertension.
- Blood transfusion, erythropoietin, granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor treatment within 2 weeks before enrollment.
- Systemic treatment with corticosteroids (prednisone >10 mg/day or equivalent) or other immunosuppressive/immunomodulatory drugs (e.g., thymosin, interleukin-2, interferon) within 2 weeks before enrollment; inhalation or topical corticosteroids are allowed in subjects without active autoimmune diseases.
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 |
|---|---|---|
| NK510Intravenous infusion | Drug | Group A (low-dose group), Group B (medium-dose group), Group C (high-dose group) |
| Tislelizumab，atezolizumab or sugemalimabAdminister according to the instructions | Drug | Group A (low-dose group), Group B (medium-dose group), Group C (high-dose group) |
| NK510intrapleural infusion | Drug | Group D1 (low-dose group), Group D2 (high-dose group) |
| systemic therapy as selected by the investigatorAdminister according to the instructions | Drug | Group D1 (low-dose group), Group D2 (high-dose group) |
Primary outcome
Dose-limiting toxicity and incidence of adverse events
Time frame: 6 weeks
To evaluate DLT and the incidence of AEs associated with NK510 treatment
Objective Response Rate
Time frame: 6 weeks
For intravenous groups: Proportion of subjects achieving CR and PR according to RECIST v1.1 after first NK510 administration; For pleural perfusion groups: Proportion of subjects achieving CR and PR according to WHO criteria after first NK510 intrapleural perfusion.
6 secondary outcomes
Progression-Free Survival
Time frame: From the date of the first dose of NK510 until disease progression, death, or a maximum of 24 months after the first dose, whichever occurs first.
Puncture-Free Survival
Time frame: From the date of the last treatment puncture to the date of the next puncture drainage, or up to a maximum of 24 months after the last treatment puncture, whichever occurs first.
Duration of Response
Time frame: From the date of first documentation of objective response to disease progression, death, or a maximum of 24 months after the date of first response, whichever occurs first.
Disease Control Rate
Time frame: From baseline tumor assessment up to the earliest of disease progression，or a maximum of 24 months after baseline.
Overall Survival
Time frame: From the date of screening enrollment to death, or a maximum of 24 months after screening enrollment, whichever occurs first.
Health-Related Quality of Life
Time frame: At screening, every 6 weeks during treatment, at study completion, or up to a maximum of 24 months after the first dose, whichever occurs first.
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 9 Sep 2026.
- 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.
Tangfeng Lv, PhD principal investigator
Jinling hospital, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NK510, Tislelizumab，atezolizumab or sugemalimab and systemic therapy as selected by the investigator in people with NSCLC, run by Base Therapeutics (Shanghai) Co., Ltd. at 1 site in China.
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 12 inclusion and 11 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 9 Sep 2026. 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 China. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jun Yan, PhD (+86 186 2166 8515, yanjun@basetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity and incidence of adverse events (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 9 Sep 2026.