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OncoMatch/Clinical Trials/NCT07480928

Dual-Targeting CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma

Is NCT07480928 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1) and EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1) for pancreatic ductal adenocarcinoma (pdac).

Phase 1/2RecruitingBeijing BiotechNCT07480928Data as of May 2026

Treatment: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1) · EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1) · Lymphodepleting chemotherapy (Flu/Cy)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.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Biomarker criteria

Required: MSLN positive expression (IHC 2+ or 3+ staining in >=50% of tumor cells, or H-score above protocol-defined cutoff)

Arm A eligibility: MSLN positive

Required: MUC1 positive expression (IHC 2+ or 3+ staining in >=50% of tumor cells, or H-score above protocol-defined cutoff)

Arm A eligibility: MUC1 positive

Required: CLDN18 positive expression (IHC 2+ or 3+ staining in >=50% of tumor cells, or H-score above protocol-defined cutoff)

Arm B eligibility: CLDN18.2 positive

Required: MUC1 positive expression (IHC 2+ or 3+ staining in >=50% of tumor cells, or H-score above protocol-defined cutoff)

Arm B eligibility: MUC1 positive

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard systemic therapy

progression after at least 1 prior standard systemic therapy regimen, or intolerance/ineligibility for standard therapy

Cannot have received: gene-modified cellular therapy (CAR-T, CAR-NK)

Exception: within 6 months or prior therapy targeting the same antigen(s)

Prior gene-modified cellular therapy (e.g., CAR-T/CAR-NK) within 6 months or prior therapy targeting the same antigen(s)

Cannot have received: allogeneic hematopoietic stem cell transplant

Prior allogeneic hematopoietic stem cell transplant

Cannot have received: solid organ transplant

Prior solid organ transplant

Lab requirements

Blood counts

anc >= 1.0 x 10^9/l; platelets >= 75 x 10^9/l; hemoglobin >= 8 g/dl

Kidney function

creatinine clearance >= 50 ml/min

Liver function

ast/alt <= 3x uln (<= 5x uln with liver metastases); total bilirubin <= 1.5x uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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