CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* Able to understand and voluntarily sign the written informed consent form (ICF).
* Male or female patients aged ≥18 years.
* Histologically and/or cytologically confirmed resectable stage IB to IIIA non-small cell lung cancer (NSCLC) according to AJCC 8th edition.
* Treatment-naïve NSCLC (no prior systemic anticancer therapy).
* No sensitizing EGFR mutations (exon 19 deletion, exon 21 L858R) and no ALK gene rearrangement.
* At least one measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Estimated life expectancy of more than 6 months.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Adequate bone marrow, liver, and renal function.
* Female participants of childbearing potential must have a negative pregnancy test prior to initiation of study treatment.

Exclusion Criteria:

* Prior receipt of any systemic anticancer therapy.
* Known sensitizing EGFR mutations or ALK gene rearrangements.
* Active, known, or suspected autoimmune disease.
* Interstitial lung disease.
* Any medical condition, therapy, or laboratory abnormality that, in the opinion of the investigator, could confound the study results, interfere with the participant's ability to comply with study procedures, or is not in the best interest of the participant.
* Locally advanced unresectable or metastatic NSCLC.
* Major cardiovascular events, unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.
* Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use effective contraception during the study.
* Any other condition judged by the investigator to make the participant unsuitable for clinical trial participation.

主要终点：Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) · Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0. · Up to 1 year after first dose of NK010；Dose Limiting Toxicities (DLTs) · Identification of DLTs to determine the maximum tolerated dose (MTD). · Up to 21 days after first dose of NK010
次要终点：Major pathological response (MPR)；Pathological complete response (pCR)；R0 Resection Rate；Objective Response Rate (ORR)

• NK010 + PD-1 Antibody + Platinum-Based Chemotherapy · EXPERIMENTAL · Participants will receive neoadjuvant therapy for a total of 3 cycles, with each cycle lasting 3 weeks. NK010 cell injection will be administered in combination with a PD-1 antibody and platinum-based chemotherapy. After completing 3 cycles of treatment, participants will undergo surgical resection, followed by pathological assessment to evaluate outcomes such as major pathological response (MPR), pathological complete response (pCR), and R0 resection rate. NK010 administration will be evaluated at three planned dose levels.

This open-label, single-arm study is designed to evaluate the safety and preliminary efficacy of NK010 cell injection combined with a PD-1 antibody and platinum-based chemotherapy as neoadjuvant therapy in patients with resectable non-small cell lung cancer (NSCLC). The study aims to assess the safety profile, feasibility of administration, and potential antitumor activity of this combination regimen.