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Recruiting Phase 1 / Phase 2

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

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About this study

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.

Condition
Non-Small Cell Lung Cancer, Advanced/Metastatic NSCLC
Tested
Dual-target CAR-NK cells, Lymphodepleting chemotherapy, Supportive Care
Sponsor
Beijing Biotech

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Non-Small Cell Lung Cancer, Advanced/Metastatic NSCLC
  • Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV, with radiographic progression on or after standard-of-care therapy (including platinum-based chemotherapy and immune checkpoint inhibitor when appropriate).
  • 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.
  • Example thresholds: IHC ≥2+ in ≥50% of tumor cells for each required antigen (or an equivalent RNA expression threshold).
  • ECOG performance status 0-1.
  • Adequate organ function (hematologic, hepatic, renal) as defined by protocol laboratory limits.
  • Life expectancy ≥12 weeks.
  • Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception for the study-defined period.
  • Ability to understand and willingness to sign written informed consent.

Exclusion 4

  • Active, uncontrolled central nervous system (CNS) metastases. Participants with previously treated/stable CNS disease may be eligible if clinically stable and off high-dose corticosteroids.
  • Prior gene-modified cellular therapy (e.g., CAR-T, CAR-NK, TCR-T) within 3 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.
  • History of severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) with prior therapies.
  • Clinically significant interstitial lung disease or pneumonitis requiring systemic steroids, or uncontrolled pulmonary comorbidity that would confound toxicity monitoring.

Where

1 site, 1 recruiting

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.