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New treatment option for Non-Small Cell Lung Cancer
Official title Dual-Target CAR-NK Cells Targeting MSLN, EGFR, or HER2 in Advanced NSCLC
ClinicalTrials.gov ID: NCT07641023
What this study is testing
What is Dual-target CAR-NK cells?
Dual-target CAR-NK cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically or cytologically confirmed NSCLC that is unresectable Stage IIIB/IIIC or Stage IV, with radiographic progression on or after...
- 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...
- ECOG performance status 0-1.
You likely can't join if
- Active, uncontrolled central nervous system (CNS) metastases. Participants with previously treated/stable CNS disease may be eligible if clinically...
- 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...
- 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...
- Active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
- Active uncontrolled infection, including uncontrolled HIV, active hepatitis B, or active hepatitis C infection.
See the full eligibility criteria
- 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...
- 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...
- 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.
- 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.
- Active autoimmune disease requiring systemic immunosuppression (physiologic steroid replacement permitted).
- Active uncontrolled infection, including uncontrolled HIV, active hepatitis B, or active hepatitis C infection.
- Significant cardiovascular disease (e.g., recent myocardial infarction, unstable angina, uncontrolled arrhythmia, or LVEF below institutional lower limit).
- Pregnant or breastfeeding.
- Concurrent anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy) within protocol-defined washout periods.
- Any condition that, in the investigator's opinion, would interfere with participant safety or compliance
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.