Under construction – not a live service
Sign in
Taking people in ChinaPhase 1/2

Dual-target CAR-NK cells tested in advanced non-small cell lung cancer

Tests dual-target CAR-NK cells in adults with advanced lung cancer.

Key facts

Who runs it
Beijing Biotech
Where
Shenzhen, ChinaSee the site
Trial code
Registry title
Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC
Status
Recruiting
Phase
Phase 1/2
People taking part
60 people, planned
Started
2 Mar 2026
Expected to end
17 Jun 2028
Type of study
Interventional, 3 groups
Treatments tested
  • Dual-target CAR-NK cells
  • Lymphodepleting chemotherapy
  • Supportive care
Record updated
11 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with advanced or metastatic non-small cell lung cancer whose tumor has at least two of three markers: MSLN, EGFR, HER2/ERBB2. They get CAR-NK cell therapy.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Non-small cell lung cancer that cannot be removed by surgery (Stage IIIB/IIIC or Stage IV). The cancer has grown on or after standard treatment. At least one lesion can be measured (RECIST v1.1).
Earlier treatment
Must have had standard treatment first, including platinum-based chemotherapy and an immune checkpoint inhibitor when appropriate. Cannot have had gene-modified cell therapy (CAR-T, CAR-NK, TCR-T) within 3 months.
Biomarker or test result
The tumor must show at least two of these antigens: MSLN, EGFR, HER2/ERBB2. Example threshold: IHC ≥2+ in ≥50% of tumor cells for each required antigen. Tumor tissue is needed for testing.

Main reasons for not taking part

  • Active, uncontrolled brain or spinal cord (CNS) metastases
  • Severe cytokine release syndrome (CRS) or ICANS with earlier treatments
  • Interstitial lung disease or pneumonitis needing steroids
  • Active autoimmune disease needing immune-suppressing treatment
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Concurrent anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy) within protocol-defined washout periods
  • Clinically significant interstitial lung disease or pneumonitis requiring systemic steroids, or uncontrolled pulmonary comorbidity that would confound toxicity monitoring
  • Active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted)
  • Active uncontrolled infection, including uncontrolled HIV, active hepatitis B, or active hepatitis C infection
  • Any condition that, in the investigator's opinion, would interfere with participant safety or compliance
  • Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or LVEF below institutional lower limit)
  • Pregnant or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Peking University Shenzhen HospitalShenzhen, ChinaContact: Zhen J Peng, PhdTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 3 groups in the trial

  • EB-DuoNK-MSLN/EGFRTreatment being tested

    Participants with tumors co-expressing MSLN and EGFR (meeting screening thresholds) receive lymphodepletion followed by EB-DuoNK-MSLN/EGFR infusion at the assigned dose leve

    Treatment: Dual-target CAR-NK cells, Lymphodepleting chemotherapy, and Supportive care

  • EB-DuoNK-MSLN/HER2Treatment being tested

    Participants with tumors co-expressing MSLN and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-MSLN/HER2 infusion at the assigned dose level.

    Treatment: Dual-target CAR-NK cells, Lymphodepleting chemotherapy, and Supportive care

  • EB-DuoNK-EGFR/HER2Treatment being tested

    Participants with tumors co-expressing EGFR and HER2/ERBB2 receive lymphodepletion followed by EB-DuoNK-EGFR/HER2 infusion at the assigned dose level.

    Treatment: Dual-target CAR-NK cells, Lymphodepleting chemotherapy, and Supportive care

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 1/2, Open-label, Biomarker-guided Study of Dual-target Chimeric Antigen Receptor Natural Killer (CAR-NK) Cells Targeting Mesothelin (MSLN) With EGFR or HER2/ERBB2, or EGFR With HER2/ERBB2, in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (NSCLC)
Plain-language title
Dual-target CAR-NK cells tested in advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07641023, who can take part
Record updated
11 June 2026