Advanced Pancreatic CancerEarly Phase 1NCT07416240
Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer.
A Early Phase 1 study testing Claudin18.2 Targeted Activated Dendritic Cells and Claudin18.2 Targeted CAR-T Cells in people with Advanced Pancreatic Cancer, run by Hainan Cancer Hospital at 1 site in China.
Trial summary
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2 Targeted Activated DC combined with CAR-T therapy in patients with Advanced Pancreatic Cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Pancreatic Cancer
- What is being tested?
- Claudin18.2 Targeted Activated Dendritic Cells and Claudin18.2 Targeted CAR-T Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2026to 18 Aug 2028
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, upper limit ≤ 80 years, gender not limited;
- Participants must have a histologically or cytologically confirmed diagnosis of advanced pancreatic cancer, with at least one measurable lesion meeting RECIST v1.1 criteria (i.e., a target lesion with a longest diameter ≥10 mm on spiral CT scan, or a lymph node with a short axis ≥15 mm).
- Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+; expression range ≥ 50%);
- Meeting the indications for PBMC collection and having no other contraindications for cell collection;
- Failure of standard second-line treatment or lack of a standard treatment regimen; or signing a refusal to undergo chemotherapy.
- ECOG score: 0-1;
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- Life expectancy: ≥ 3 months;
- Toxic reactions from previous chemotherapy and other anti-tumor treatments must be resolved through a washout period (except for residual hair loss), ensuring that all functional parameters meet the inclusion criteria;
- Sufficient organ function, including:
- Sufficient immune function, i.e., absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L.
- Sufficient hematopoietic function, i.e., platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the complete blood count examination. c) Sufficient liver function, i.e., total bilirubin (TBIL) < 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN.
- Sufficient kidney function, i.e., creatinine (Cr) ≤ 1.5 × ULN. e) Sufficient coagulation function, i.e., prothrombin time (PT) or activated partial thromboplastin time (APTT) < 1.5 × ULN, and international normalized ratio (INR) < 1.5.
- Individuals of fertility must be willing to use contraception;
- Sufficient understanding and willingness to sign an informed consent form;
- Willingness to comply with visit schedules, medication plans, laboratory tests, and other trial procedures.
Who cannot join
- Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc.
- Significant cardiovascular disease, such as:
- • A confirmed cardiovascular event within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or previous angioplasty, stent implantation, or coronary artery bypass grafting;
- • Clinically significant QT interval prolongation (QTcF > 470ms for women or QTcF > 450ms for men).
- Clinically significant bleeding tendency or coagulation disorders, such as hemophilia;
- HIV infection, syphilis infection, hepatitis B infection, or hepatitis C infection.
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- History of involuntary custody due to mental illness or other mental illness deemed unsuitable for treatment by the treating physician;
- Accompanied by other autoimmune diseases, or long-term use of immunosuppressants or steroids;
- Poor patient compliance as assessed by the investigator;
- Previous treatment with any target CAR-T within 3 months prior to this CAR-T treatment;
- Uncontrollable active bacterial or fungal infections;
- Other conditions deemed necessary to be ruled out by the physician.
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
Hainan Cancer Hospital
Haikou, Hainan, 570311
HAIFENG LIN, 13322060949, 13322060949@163.com
About this study
Official title: Exploratory Clinical Study of Combined Claudin18.2-Targeted Activated DC and CAR-T Therapy in Patients With Advanced Pancreatic Cancer
This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2 Targeted Activated DC combined with CAR-T therapy in patients with Advanced Pancreatic Cancer.
This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
- Conditions
- Advanced Pancreatic Cancer
- Being tested
- Claudin18.2 Targeted Activated Dendritic Cells, Claudin18.2 Targeted CAR-T Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Claudin18.2 Targeted Activated Dendritic CellsBiological
Autologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain
Claudin18.2 Targeted CAR-T CellsBiological
Autologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR)
| Study group | Role | What they receive |
|---|---|---|
| Targeted Activated DC and CAR-T Combination Therapy | Experimental | Not described Receives: Biological: Claudin18.2 Targeted Activated Dendritic Cells; Biological: Claudin18.2 Targeted CAR-T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AEs)
Incidence and severity of adverse events
Measured: 2 years
Secondary outcomes (4)
Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Measured: 2 years
Disease Control Rate (DCR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1
Measured: 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause
Measured: 2 years
Changes in the Immune Microenvironment
Assess the changes in the tumor immune microenvironment before and after subjects received combined therapy with Claudin18.2 targeted activated dendritic cells (DCs) and CAR-T cells.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start18 Feb 2026 (estimated)
- Primary completion18 Feb 2028 (estimated)
- Study completion18 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hainan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frontiergate Biopharm（Hainan） Co., LTD
- Responsible party
- Sponsor
- Investigators
- HAIFENG LIN, Principal investigator, Hainan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416240
- Sponsor's protocol ID
- EC-2026-005-01
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request. The data will be available beginning 6 months and ending 5 years following publication. Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study of Combined Claudin18.2-Targeted Activated DC and CAR-T Therapy in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07416240
- Acronym / sponsor ID
- EC-2026-005-01
- Conditions
- Advanced Pancreatic Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hainan Cancer HospitalUniversity, hospital or other
- Collaborators
- Frontiergate Biopharm（Hainan） Co., LTD
- Study start
- 18 Feb 2026 (estimated)
- Primary completion
- 18 Feb 2028 (estimated)
- Study completion
- 18 Aug 2028 (estimated)
- First posted
- 18 Feb 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 is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2 Targeted Activated DC combined with CAR-T therapy in patients with Advanced Pancreatic Cancer.
This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Activated DC and CAR-T Combination Therapy | Experimental | Biological: Claudin18.2 Targeted Activated Dendritic Cells, Biological: Claudin18.2 Targeted CAR-T Cells |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years, upper limit ≤ 80 years, gender not limited;
- Participants must have a histologically or cytologically confirmed diagnosis of advanced pancreatic cancer, with at least one measurable lesion meeting RECIST v1.1 criteria (i.e., a target lesion with a longest diameter ≥10 mm on spiral CT scan, or a lymph node with a short axis ≥15 mm).
- Tumor tissue positive for Claudin 18.2 by immunohistochemical detection (expression intensity ≥ 2+; expression range ≥ 50%);
- Meeting the indications for PBMC collection and having no other contraindications for cell collection;
- Failure of standard second-line treatment or lack of a standard treatment regimen; or signing a refusal to undergo chemotherapy.
Key exclusion criteria (12 listed)
- Emergency oncological conditions requiring immediate treatment, such as malignant pericardial effusion or tamponade, superior vena cava obstruction syndrome, spinal cord compression, etc.
- Significant cardiovascular disease, such as:
- Clinically significant bleeding tendency or coagulation disorders, such as hemophilia;
- HIV infection, syphilis infection, hepatitis B infection, or hepatitis C infection.
- History of involuntary custody due to mental illness or other mental illness deemed unsuitable for treatment by the treating physician;
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 |
|---|---|---|
| Claudin18.2 Targeted Activated Dendritic CellsAutologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain | Biological | Targeted Activated DC and CAR-T Combination Therapy |
| Claudin18.2 Targeted CAR-T CellsAutologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) | Biological | Targeted Activated DC and CAR-T Combination Therapy |
Primary outcome
Adverse Events (AEs)
Time frame: 2 years
Incidence and severity of adverse events
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Changes in the Immune Microenvironment
Time frame: 1 month
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 18 Feb 2026.
- Individual participant dataSharing planned: Yes. Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request. The data will be available beginning 6 months and ending 5 years following publication. Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.
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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.
HAIFENG LIN principal investigator
Hainan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Claudin18.2 Targeted Activated Dendritic Cells and Claudin18.2 Targeted CAR-T Cells in people with Advanced Pancreatic Cancer, run by Hainan Cancer Hospital 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 15 inclusion and 12 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 18 Feb 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 HAIFENG LIN (+86-13322060949, 13322060949@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (AEs) (time frame: 2 years). 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 18 Feb 2026.