Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1/2DUAL-NK-PDACNCT07627711
Dual-Target CAR-NK Cells Targeting Mesothelin (MSLN) and MUC1 in Advanced Pancreatic Ductal Adenocarcinoma
A Phase 1/2 study testing EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1) and Lymphodepleting chemotherapy (Flu/Cy) in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Unresectable Locally Advanced, run by Beijing Biotech at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease
- What is being tested?
- EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1) and Lymphodepleting chemotherapy (Flu/Cy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 17 Mar 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: A Phase 1/2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2/MUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
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.
Read the detailed description
- Rationale: PDAC is characterized by aggressive biology, antigen heterogeneity, and an immunosuppressive tumor microenvironment. Dual-targeting CAR designs aim to reduce antigen-escape by enabling recognition of either target antigen on tumor cells.
- Investigational products: Two off-the-shelf (allogeneic) CAR-NK products are evaluated. EB-DNK101 targets MSLN and MUC1. EB-DNK102 targets CLDN18.2 and MUC1. Both products are engineered to enhance persistence and incorporate an inducible safety switch .
- Target assessment and cohort assignment: Tumor tissue (archival or fresh biopsy) is tested centrally by immunohistochemistry (IHC) for MSLN, MUC1, and CLDN18.2. Participants are assigned to Arm A (MSLN/MUC1) or Arm B (CLDN18.2/MUC1) based on predefined positivity thresholds. If more than one cohort is eligible, assignment prioritizes the strongest antigen expression and product availability.
- Conditioning and administration: Participants receive lymphodepleting chemotherapy followed by intravenous infusion of the assigned CAR-NK product.
Repeat infusions (up to 3 total) may be permitted in the absence of prohibitive toxicity and with at least stable disease. Safety monitoring: Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.
Dose-limiting toxicities (DLTs) are assessed during the first 28 days after first infusion.
- Efficacy and biomarker assessments: Tumor response is assessed by imaging (RECIST v1.1) at regular intervals (every 8 weeks). Exploratory endpoints include CAR-NK expansion/persistence, cytokine profiling, and association of antigen density with response.
- Target down-selection plan: After completion of Part 1 and an initial subset of Part 2 expansion participants, an internal scientific review compares antigen prevalence, manufacturability, safety, and preliminary activity across cohorts to prioritize the lead dual-target construct for subsequent confirmatory development.
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease
- Being tested
- EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Lymphodepleting chemotherapy (Flu/Cy)
- Keywords
- Pancreatic cancer, PDAC, CAR-NK, Natural killer cells, Mesothelin, MSLN, MUC1, Claudin 18.2, CLDN18.2, Adoptive cell therapy, Immunotherapy, Biomarker-guided
- Medical subject headings
- Neoplasm Metastasis, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)Biological
Also called MSLN/MUC1 Dual-CAR NK, Dual-target CAR-NK (MSLN/MUC1)
Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting MSLN and MUC1. Administered as an IV infusion on Day 0 (dose level dependent).
EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)Biological
Also called CLDN18.2/MUC1 Dual-CAR NK, Dual-target CAR-NK (CLDN18.2/MUC1)
Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting CLDN18.2 and MUC1. Administered as an IV infusion on Day 0 (dose level dependent).
Lymphodepleting chemotherapy (Flu/Cy)Drug
Also called Fludarabine + Cyclophosphamide, Conditioning regimen
fludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to
-4) prior to CAR-NK infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK) | Experimental | Participants with PDAC whose tumors express MSLN and/or MUC1 per central IHC are assigned to Arm A. Receives: Biological: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1); Biological: EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1); Drug: Lymphodepleting chemotherapy (Flu/Cy) |
| Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK) | Experimental | Participants with PDAC whose tumors express CLDN18.2 and/or MUC1 per central IHC are assigned to Arm B. Receives: Biological: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1); Biological: EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1); Drug: Lymphodepleting chemotherapy (Flu/Cy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicities (DLTs)
Measured: 28 Days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: 12 months
Maximum tolerated dose (MTD)
Measured: 12 months
Secondary outcomes (3)
Objective response rate (ORR) per RECIST v1.1
Measured: 12 months
Disease control rate (DCR)
Measured: 12 months
Duration of response (DOR)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start2 Mar 2026
- Primary completion14 Apr 2027 (estimated)
- Study completion17 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal Adenocarcinoma (PDAC)Studies of the same condition, open and under way.
- More trials run by Beijing BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Biomarker-guided, multi-cohort study with a dose-escalation (Part 1) followed by dose-expansion (Part 2) within each cohort/arm.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627711
- Sponsor's protocol ID
- ESSEN-PDAC-DNK-008
- Acronym
- DUAL-NK-PDAC
- Status last verified
- May 2026
- First submitted
- 31 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-label, Biomarker-guided, Dose-escalation and Expansion Study of Dual-targeting CAR-NK Cells Directed Against Mesothelin (MSLN) and MUC1, With an Exploratory CLDN18.2/MUC1 Dual-target Cohort, in Patients With Unresectable or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- ClinicalTrials.gov ID
- NCT07627711
- Acronym / sponsor ID
- DUAL-NK-PDAC / ESSEN-PDAC-DNK-008
- Conditions
- Pancreatic Ductal Adenocarcinoma (PDAC), Unresectable Locally Advanced, Metastatic Disease
- Keywords
- Pancreatic cancer, PDAC, CAR-NK, Natural killer cells, Mesothelin, MSLN, MUC1, Claudin 18.2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Beijing BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 14 Apr 2027 (estimated)
- Study completion
- 17 Mar 2028 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Rationale: PDAC is characterized by aggressive biology, antigen heterogeneity, and an immunosuppressive tumor microenvironment. Dual-targeting CAR designs aim to reduce antigen-escape by enabling recognition of either target antigen on tumor cells.
- Investigational products: Two off-the-shelf (allogeneic) CAR-NK products are evaluated. EB-DNK101 targets MSLN and MUC1. EB-DNK102 targets CLDN18.2 and MUC1. Both products are engineered to enhance persistence and incorporate an inducible safety switch .
- Target assessment and cohort assignment: Tumor tissue (archival or fresh biopsy) is tested centrally by immunohistochemistry (IHC) for MSLN, MUC1, and CLDN18.2. Participants are assigned to Arm A (MSLN/MUC1) or Arm B (CLDN18.2/MUC1) based on predefined positivity thresholds. If more than one cohort is eligible, assignment prioritizes the strongest antigen expression and product availability.
- Conditioning and administration: Participants receive lymphodepleting chemotherapy followed by intravenous infusion of the assigned CAR-NK product.
Repeat infusions (up to 3 total) may be permitted in the absence of prohibitive toxicity and with at least stable disease. Safety monitoring: Participants are monitored closely for cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infusion reactions, and other adverse events.
Dose-limiting toxicities (DLTs) are assessed during the first 28 days after first infusion.
- Efficacy and biomarker assessments: Tumor response is assessed by imaging (RECIST v1.1) at regular intervals (every 8 weeks). Exploratory endpoints include CAR-NK expansion/persistence, cytokine profiling, and association of antigen density with response.
- Target down-selection plan: After completion of Part 1 and an initial subset of Part 2 expansion participants, an internal scientific review compares antigen prevalence, manufacturability, safety, and preliminary activity across cohorts to prioritize the lead dual-target construct for subsequent confirmatory development.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Biomarker-guided, multi-cohort study with a dose-escalation (Part 1) followed by dose-expansion (Part 2) within each cohort/arm.
| Arm | Type | Receives |
|---|---|---|
| Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK) | Experimental | Biological: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), Biological: EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Drug: Lymphodepleting chemotherapy (Flu/Cy)Participants with PDAC whose tumors express MSLN and/or MUC1 per central IHC are assigned to Arm A. |
| Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK) | Experimental | Biological: EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), Biological: EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1), Drug: Lymphodepleting chemotherapy (Flu/Cy)Participants with PDAC whose tumors express CLDN18.2 and/or MUC1 per central IHC are assigned to Arm B. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.)
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1)Also: MSLN/MUC1 Dual-CAR NK, Dual-target CAR-NK (MSLN/MUC1)Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting MSLN and MUC1. Administered as an IV infusion on Day 0 (dose level dependent). | Biological | Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK), Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK) |
| EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1)Also: CLDN18.2/MUC1 Dual-CAR NK, Dual-target CAR-NK (CLDN18.2/MUC1)Allogeneic CAR-NK cells engineered with a dual-recognition CAR targeting CLDN18.2 and MUC1. Administered as an IV infusion on Day 0 (dose level dependent). | Biological | Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK), Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK) |
| Lymphodepleting chemotherapy (Flu/Cy)Also: Fludarabine + Cyclophosphamide, Conditioning regimenfludarabine (Days -5 to -3) and cyclophosphamide (Days -5 to -4) prior to CAR-NK infusion. | Drug | Arm A: EB-DNK101 (MSLN/MUC1 Dual-CAR NK), Arm B: EB-DNK102 (CLDN18.2/MUC1 Dual-CAR NK) |
Primary outcome
Incidence of dose-limiting toxicities (DLTs)
Time frame: 28 Days
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 12 months
Maximum tolerated dose (MTD)
Time frame: 12 months
3 secondary outcomes
Objective response rate (ORR) per RECIST v1.1
Time frame: 12 months
Disease control rate (DCR)
Time frame: 12 months
Duration of response (DOR)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EB-DNK101 dual-targeting CAR-NK cells (MSLN + MUC1), EB-DNK102 dual-targeting CAR-NK cells (CLDN18.2 + MUC1) and Lymphodepleting chemotherapy (Flu/Cy) in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Unresectable Locally Advanced, run by Beijing Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities (DLTs) (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.