Pancreatic CancerPhase 1NCT06816823
CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
A Phase 1 study testing CL-NK-001 in people with Pancreatic Cancer, run by Changhai Hospital at 1 site in China.
Trial summary
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- CL-NK-001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2025to Dec 2025
- Phase
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years;
- Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate >40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;
- At least 1 measurable lesion according to RECIST 1.1;
- Have not received anti-tumor treatment for at least 4 weeks;
- ECOG performance status of 0-2;
- Estimated life expectancy more than 12 weeks;
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- Hematology: neutrophils ≥ 1.5×10^9/L, lymphocytes ≥ 0.8×10^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10^9/L;
- Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);
- Volunteer to participate in this clinical study and willing to sign written informed consent.
Who cannot join
- Evidence of central nervous system involvement;
- Have received adoptive cell therapy;
- Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;
- Vaccinated with a live attenuated vaccine within 3 months;
- History of immunodeficiency;
- Active autoimmune disease;
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- Have severe conditions, including but not limited to: (1) severe respiratory diseases; (2) severe cardiovascular diseases (previous history of CABG/PCI; myocardial infarction/unstable angina pectoris, congestive heart failure of NYHA III-IV, left ventricular ejection fraction < 50%, or poorly controlled hypertension within 6 months; QTc interval > 480ms, long or short QT syndrome; previous history of ventrical arrhythmia, or ventrical arrhythmia under anti-arrhythmic drugs/ICD); (3) poorly controlled diabetes and other metabolic diseases; (4) severe gastrointestinal diseases (severe gastrointestinal bleeding, severe diarrhea of CTCAE ≥ 2, or severe gastrointestinal obstruction needing intervention);
- Possible severe adverse events, allergy or other contraindications to drugs or its component under study;
- Pregnant or lactating women;
- History of neurological or psychological disorders;
- Not suitable to participate this clinical study judged by the investigator.
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
Changhai Hospital
Shanghai, 200433
Yanfang Liu, MD PhD, +86-13124828854, liuyanfang00215@163.com
About this study
Official title: A Clinical Study of CAR-NK Cells (CL-NK-001) in Patients With Advanced Pancreatic Cancer
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
Read the detailed description
A dose-escalation study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
- Conditions
- Pancreatic Cancer
- Being tested
- CL-NK-001
- Keywords
- pancreatic cancer, CAR-NK
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CL-NK-001Biological
Dose level 1 (5 × 10^8 cells); dose level 2 (15 × 10^8 cells); dose level 3 (30 × 10^8 cells); additional dose levels (investigator's discretion).
| Study group | Role | What they receive |
|---|---|---|
| CL-NK-001 | Experimental | Dose escalation of at least 3 dose levels Receives: Biological: CL-NK-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Safety
Measured: 42 days of first infusion
Maximum tolerated dose (MTD)
Tolerability
Measured: 42 days of first infusion
Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)
Safety
Measured: 42 days of first infusion
Number of participants with abnormal clinical laboratory parameters reported as TEAE
Safety
Measured: 42 days of first infusion
Number of participants with abnormal vital signs reported as TEAE
Safety
Measured: 42 days of first infusion
Number of participants with change from baseline in QT/QTc interval in electrocardiogram
Safety
Measured: 42 days of first infusion
Secondary outcomes (6)
Objective response rate (ORR)
Efficacy
Measured: 42 days of first infusion
Disease control rate (DCR)
Efficacy
Measured: 42 days of first infusion
Progression-free survival (PFS)
Efficacy
Measured: 6 months
Overall survival (OS)
Efficacy
Measured: 6 months
Patient-reported quality of life (QoL)
Measured by the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30)
Measured: 42 days of first infusion
Patient-generated subjective global assessment (PG-SGA)
Nutritional status measurement with a medical history section assessed by patients and a physical assessment section assessed by medical staff
Measured: 42 days of first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start7 Apr 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhuan Liao, Changhai Hospital
- Investigators
- Zhuan Liao, MD PhD, Principal investigator, Changhai HospitalXuetao Cao, MD PhD, Principal investigator, National Key Laboratory of Immunity & Inflammation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816823
- Sponsor's protocol ID
- CHEC2025-028
- Status last verified
- Jun 2025
- First submitted
- 1 Feb 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of CAR-NK Cells (CL-NK-001) in Patients With Advanced Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06816823
- Acronym / sponsor ID
- CHEC2025-028
- Conditions
- Pancreatic Cancer
- Keywords
- pancreatic cancer, CAR-NK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Feb 2025 (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 a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
Detailed description
A dose-escalation study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CL-NK-001 | Experimental | Biological: CL-NK-001Dose escalation of at least 3 dose levels |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18-70 years;
- Locally advanced, metastatic, or recurrent pancreatic cancer, with immunohistochemical detection of eGR1 (membrane positive tumor cell rate >40% and expression intensity ≥2+), who have failed, been intolerant to or reject standard treatment;
- At least 1 measurable lesion according to RECIST 1.1;
- Have not received anti-tumor treatment for at least 4 weeks;
- ECOG performance status of 0-2;
Key exclusion criteria (11 listed)
- Evidence of central nervous system involvement;
- Have received adoptive cell therapy;
- Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;
- Vaccinated with a live attenuated vaccine within 3 months;
- History of immunodeficiency;
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 |
|---|---|---|
| CL-NK-001Dose level 1 (5 × 10^8 cells); dose level 2 (15 × 10^8 cells); dose level 3 (30 × 10^8 cells); additional dose levels (investigator's discretion). | Biological | CL-NK-001 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 42 days of first infusion
Safety
Maximum tolerated dose (MTD)
Time frame: 42 days of first infusion
Tolerability
Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)
Time frame: 42 days of first infusion
Safety
Number of participants with abnormal clinical laboratory parameters reported as TEAE
Time frame: 42 days of first infusion
Safety
Number of participants with abnormal vital signs reported as TEAE
Time frame: 42 days of first infusion
Safety
Number of participants with change from baseline in QT/QTc interval in electrocardiogram
Time frame: 42 days of first infusion
Safety
6 secondary outcomes
Objective response rate (ORR)
Time frame: 42 days of first infusion
Disease control rate (DCR)
Time frame: 42 days of first infusion
Progression-free survival (PFS)
Time frame: 6 months
Overall survival (OS)
Time frame: 6 months
Patient-reported quality of life (QoL)
Time frame: 42 days of first infusion
Patient-generated subjective global assessment (PG-SGA)
Time frame: 42 days of first infusion
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 2025.
- Individual participant dataSharing planned: No
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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.
Zhuan Liao, MD PhD principal investigator
Changhai Hospital
Xuetao Cao, MD PhD principal investigator
National Key Laboratory of Immunity & Inflammation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CL-NK-001 in people with Pancreatic Cancer, run by Changhai 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 9 inclusion and 11 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 2025. 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?
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.
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 Yanfang Liu, MD PhD (+86-13124828854, liuyanfang00215@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 42 days of first infusion). The study lists 6 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 2025.