Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC

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.

Trial Details

NCT ID
NCT07641023
Phase
PHASE1 / PHASE2
Sponsor
Beijing Biotech
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Dual-target CAR-NK cells
  • Lymphodepleting chemotherapy
  • Supportive care
Locations (sample)
  • Shenzhen, Guangdong, China|22.54554,114.0683

Key Eligibility Criteria

  • Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV, with radiographic progression on or after standar…
  • At least one measurable lesion per RECIST v1.1.
  • Archival tumor tissue available (or willingness to undergo a fresh biopsy) for antigen testing.
  • Tumor co-expression of at least two of the following antigens at screening: MSLN, EGFR, HER2/ERBB2.

For full eligibility, visit ClinicalTrials.gov.

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