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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Other

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

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT07480928 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior gene-modified cellular therapy, allogeneic hematopoietic stem cell transplant, solid organ transplant disqualifies patients from enrollment.

Does this trial require MSLN?

Yes, MSLN positive expression is a required biomarker for enrollment.

Does this trial require MUC1?

Yes, MUC1 positive expression is a required biomarker for enrollment.

Does this trial require CLDN18?

Yes, CLDN18 positive expression is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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