A Phase 1/2 interventional study of Dual-target CAR-NK cells and Lymphodepleting chemotherapy in Non-Small Cell Lung Cancer and Advanced/Metastatic NSCLC, sponsored by Beijing Biotech. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Beijing Biotech · Phase 1/2, Interventional, and Treatment
This is a two-part, biomarker-guided Phase 1/2 study evaluating the safety, feasibility, and preliminary anti-tumor activity of off-the-shelf dual-target CAR-NK cells in participants with advanced or metastatic NSCLC whose tumors co-express at least two of the following antigens: Mesothelin (MSLN), EGFR, and HER2/ERBB2.
Participants will receive lymphodepleting chemotherapy followed by infusion of the CAR-NK product matched to their tumor antigen profile. A data-driven interim assessment will be used to select the most suitable construct for expansion.
The study includes Part A (dose escalation) and Part B (dose expansion). In Part A, participants are assigned to one of three dual-target CAR-NK constructs based on tumor antigen co-expression (IHC and/or RNA profiling): MSLN/EGFR, MSLN/HER2, or EGFR/HER2. Dose escalation within each construct follows a standard 3+3 design to identify a recommended Phase 2 dose (RP2D). In Part B, the study expands at the RP2D and may adaptively prioritize the construct demonstrating the most favorable benefit-risk profile (e.g., acceptable safety with early signals of response). Key exploratory objectives include CAR-NK persistence, immune pharmacodynamics, cytokine profiling, and correlations between antigen density and clinical outcomes. This document is an example ClinicalTrials.gov-style registration template for planning purposes only and is not an actual registered study
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 48 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Beijing Biotech is the lead sponsor of 32 studies on the registry; 32 are open to participants now.
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Example thresholds: IHC ≥2+ in ≥50% of tumor cells for each required antigen (or an equivalent RNA expression threshold).
Exclusion Criteria:
Participants with tumors co-expressing MSLN and EGFR (meeting screening thresholds) receive lymphodepletion followed by EB-DuoNK-MSLN/EGFR infusion at the assigned dose level.
Biological: Dual-target CAR-NK cells · Drug: Lymphodepleting chemotherapy · Other: Supportive Care
Participants with tumors co-expressing MSLN and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-MSLN/HER2 infusion at the assigned dose level.
Biological: Dual-target CAR-NK cells · Drug: Lymphodepleting chemotherapy · Other: Supportive Care
Participants with tumors co-expressing EGFR and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-EGFR/HER2 infusion at the assigned dose level.
Biological: Dual-target CAR-NK cells · Drug: Lymphodepleting chemotherapy · Other: Supportive Care
Allogeneic cord-blood-derived NK cells engineered to express a dual-target CAR (tandem OR-gate) and IL-15 for enhanced persistence; includes an inducible safety switch (e.g., iCasp9). Infused intravenously on Day 0 (with optional repeat infusion on Day 7 in expansion, per protocol).
Fludarabine + Cyclophosphamide administered on Days -5, -4, and -3 prior to CAR-NK infusion
Premedication and management per institutional guidelines (e.g., acetaminophen/antihistamine pre-infusion; tocilizumab and corticosteroids per CRS/ICANS management algorithm)
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 Days
Objective response rate (ORR)
Time frame: 6 months
Duration of response (DOR) per RECIST v1.1.
Time frame: 12 months
Progression-free survival (PFS).
Time frame: 12 months
Overall survival (OS)
Time frame: 24 months
Plan to share: Undecided
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