Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
Recruiting now · Phase 1/Phase 2
Conditions studied: Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease
In brief
This example study evaluates the safety, tolerability, and preliminary anti-tumor activity of investigational, dual-targeting chimeric antigen receptor natural killer (CAR-NK) cell products for patients with advanced pancreatic ductal adenocarcinoma (PDAC). Participants are assigned to one of two biomarker-defined cohorts based on tumor antigen expression: (A) Mesothelin (MSLN) and/or MUC1, or (B) Claudin 18.2 (CLDN18.2) and/or MUC1. The study uses a dose-escalation followed by dose-expansion design to define a recommended Phase 2 dose (RP2D) and to estimate response rates in each cohort.
Key facts
- Study ID
- NCT07627711
- Run by
- Beijing Biotech
- People needed
- 42
- Starts
- 2026-03-02
- Expected to finish
- 2028-03-17
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 to 75 years at the time of consent.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC).
- Unresectable locally advanced or metastatic disease with progression after at least 1 prior standard systemic therapy regimen, or intolerance/ineligibility for standard therapy.
- At least 1 measurable lesion per RECIST v1.1.
- Tumor antigen expression by central IHC (archival or fresh biopsy): • Arm A eligibility: MSLN positive and/or MUC1 positive. • Arm B eligibility: CLDN18.2 positive and/or MUC1 positive. (Example threshold: IHC 2+ or 3+ staining in >=50% of tumor cells, or H-score above protocol-defined cutoff.)
- ECOG performance status 0-1.
- Adequate organ function (example): ANC >= 1.0 x 10\^9/L; platelets >= 75 x 10\^9/L; hemoglobin >= 8 g/dL; AST/ALT <= 3x ULN (<= 5x ULN with liver metastases); total bilirubin <= 1.5x ULN; creatinine clearance >= 50 mL/min.
- Life expectancy >= 12 weeks.
- Negative pregnancy test for individuals of childbearing potential; agreement to use effective contraception during study participation and for a protocol-defined follow-up period.
- Ability to understand and willingness to sign written informed consent.
You may not qualify if…
- Active or untreated CNS metastases or carcinomatous meningitis.
- Clinically significant uncontrolled infection (including uncontrolled bacterial, fungal, or viral infection).
- Known active hepatitis B or hepatitis C with detectable viral load; known uncontrolled HIV infection.
- Prior allogeneic hematopoietic stem cell transplant or solid organ transplant.
- Prior gene-modified cellular therapy (e.g., CAR-T/CAR-NK) within 6 months or prior therapy targeting the same antigen(s) Ongoing requirement for systemic immunosuppressive therapy (e.g., chronic corticosteroids above physiologic replacement).
- Clinically significant cardiovascular disease (e.g., recent myocardial infarction, uncontrolled arrhythmia, or NYHA class III/IV heart failure) within a protocol-defined period.
- Active autoimmune disease requiring systemic treatment in the past 2 years (replacement therapy allowed).
- Pregnant or breastfeeding.
- Any medical, psychiatric, or social condition that, in the investigator's opinion, would interfere with safe participation or interpretation of results.
Where it is running
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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