Dual-target CAR-NK therapy targeting mesothelin and MUC1 for advanced pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, open-label study uses a dose-escalation followed by dose-expansion design to define a recommended Phase 2 dose and estimate response rates in biomarker-defined cohorts. Two allogeneic CAR-NK products are tested: EB-DNK101 targeting MSLN and MUC1, and EB-DNK102 targeting CLDN18.2 and MUC1, both engineered for enhanced persistence and an inducible safety switch. Central immunohistochemistry on archival or fresh tumor tissue assigns participants to Arm A (MSLN/MUC1) or Arm B (CLDN18.2/MUC1), with lymphodepleting chemotherapy (fludarabine + cyclophosphamide) administered before intravenous CAR-NK infusion. Repeat infusions (up to three) may be permitted in the absence of prohibitive toxicity, with close monitoring for cytokine release syndrome, neurotoxicity, infusion reactions, and other adverse events while tumor response is assessed per RECIST.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Where it's running

• Peking University Shenzhen Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: Seni S Lu, Phd
• Email: Seni-Lu@beijing-biotech.com
• Phone: +86 13076790030

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.