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RecruitingNCT07425483Updated Feb 23, 2026

CAR-NK Cells (CL-NK-003) in Pancreatic Cancer

A Phase 1 interventional study of CL-NK-003 in Pancreatic Cancer, sponsored by Changhai Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-23.

Sponsored by Changhai Hospital · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.

Read the detailed description

A fixed-dose study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-003) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.

02

Conditions studied

  • Pancreatic Cancer

Keywords

  • pancreatic cancer
  • CAR-NK
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 9 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Changhai Hospital is the lead sponsor of 342 studies on the registry; 133 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 1. Aged 18-75 years;2. 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;3. At least 1 measurable lesion according to RECIST 1.1;4. Have not received anti-tumor treatment for at least 4 weeks;5. ECOG performance status of 0-2;6. Estimated life expectancy more than 12 weeks;7. Hematology: neutrophils ≥ 1.5×10\^9/L, lymphocytes ≥ 0.8×10\^9/L, hemoglobin ≥ 100 g/L, and platelets ≥ 75 × 10\^9/L;8. Blood biochemistry: total bilirubin ≤ 2×ULN, alanine aminotransferase ≤ 3×ULN, aspartate aminotransferase ≤ 3×ULN, and creatinine clearance ≥ LLN (Cockcroft-Gault formula);9. Volunteer to participate in this clinical study and willing to sign written informed consent.

Exclusion criteria

Exclusion Criteria:

  • 1. Evidence of central nervous system involvement;2. Have received adoptive cell therapy;3. Patients with any uncontrolled active infection, including but not limited to: HBV, HCV, HIV, or treponema pallidum serology positive;4. Vaccinated with a live attenuated vaccine within 3 months;5. History of immunodeficiency;6. Active autoimmune disease;7. Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg/day (or equivalent) on any day; 8. 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);9. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;10. Pregnant or lactating women;11. History of neurological or psychological disorders;12. Not suitable to participate this clinical study judged by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (estimated)

Study arms

  • Experimental
    CL-NK-003

    Fixed-dose for at least 6 patients

    Biological: CL-NK-003

Interventions

  • BiologicalCL-NK-003

    Fixed-dose (3 × 10\^9 cells)

06

What researchers measure

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Safety

    Time frame: 42 days of first infusion

  2. Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)

    Safety

    Time frame: 42 days of first infusion

  3. Number of participants with abnormal clinical laboratory parameters reported as TEAE

    Safety

    Time frame: 42 days of first infusion

  4. Number of participants with abnormal vital signs reported as TEAE

    Safety

    Time frame: 42 days of first infusion

  5. Number of participants with change from baseline in QT/QTc interval in electrocardiogram

    Safety

    Time frame: 42 days of first infusion

Secondary outcomes

  1. Objective response rate (ORR)

    Efficacy

    Time frame: 42 days of first infusion

  2. Disease control rate (DCR)

    Efficacy

    Time frame: 42 days of first infusion

  3. Progression-free survival (PFS)

    Efficacy

    Time frame: 6 months

  4. Overall survival (OS)

    Efficacy

    Time frame: 6 months

  5. Patient-reported quality of life (QoL)

    Measured by the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30)

    Time frame: 42 days of first infusion

  6. 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

    Time frame: 42 days of first infusion

07

Study locations

1 of 1 sites recruiting
  • Changhai Hospital
    Shanghai, 200433, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07425483
Lead sponsor
Changhai Hospital
Collaborators
National Key Laboratory of Immunity and Inflammation
Responsible party
Zhuan Liao (Prof., Changhai Hospital) — Principal investigator
First posted
Feb 23, 2026
Start date
Feb 12, 2026
Primary completion
Dec 2026 (estimated)
Completion
Dec 2028 (estimated)
Last update
Feb 23, 2026

Study contacts

Xuetao Cao
Contact
caoxt@immunol.org
+86-13124828854
Zhuan Liao
principal investigator · Changhai Hospital
Xuetao Cao
principal investigator · National Key Laboratory of Immunity & Inflammation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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