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Recruiting NCT06816823

CAR-NK Cells (CL-NK-001) in Pancreatic Cancer

Phase I Interventional Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CL-NK-001.
Who it may be relevant to
Registry conditions: Pancreatic Cancer. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Clinical Study of CAR-NK Cells (CL-NK-001) in Patients With Advanced Pancreatic Cancer

Overview

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.

Interventions

  • Biological CL-NK-001
    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).

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: 42 days of first infusion]
  • Maximum tolerated dose (MTD) [Time frame: 42 days of first infusion]
  • Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE) [Time frame: 42 days of first infusion]
  • Number of participants with abnormal clinical laboratory parameters reported as TEAE [Time frame: 42 days of first infusion]
  • Number of participants with abnormal vital signs reported as TEAE [Time frame: 42 days of first infusion]
  • Number of participants with change from baseline in QT/QTc interval in electrocardiogram [Time frame: 42 days of first infusion]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Changhai Hospital — Shanghai

Identifiers

NCT: NCT06816823 · CHEC2025-028

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗