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

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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Biological: CL-NK-001

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yanfang Liu, MD PhD; Phone Number: +86-13124828854; Email: liuyanfang00215@163.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital
    • Contact: Yanfang Liu, MD PhD; Phone Number: +86-13124828854; Email: liuyanfang00215@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-70 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:

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. 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);
8. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;
9. Pregnant or lactating women;
10. History of neurological or psychological disorders;
11. Not suitable to participate this clinical study judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CL-NK-001; Dose escalation of at least 3 dose levels	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	Safety	42 days of first infusion
Maximum tolerated dose (MTD)	Tolerability	42 days of first infusion
Treatment-emergent adverse event (TEAE) and treatment-emergent serious adverse event (TESAE)	Safety	42 days of first infusion
Number of participants with abnormal clinical laboratory parameters reported as TEAE	Safety	42 days of first infusion
Number of participants with abnormal vital signs reported as TEAE	Safety	42 days of first infusion
Number of participants with change from baseline in QT/QTc interval in electrocardiogram	Safety	42 days of first infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Efficacy	42 days of first infusion
Disease control rate (DCR)	Efficacy	42 days of first infusion
Progression-free survival (PFS)	Efficacy	6 months
Overall survival (OS)	Efficacy	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)	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	42 days of first infusion

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Investigators: Principal Investigator: Zhuan Liao, MD PhD, Changhai Hospital; Principal Investigator: Xuetao Cao, MD PhD, National Key Laboratory of Immunity & Inflammation

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 1, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: pancreatic cancer; CAR-NK
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CHEC2025-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No