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

NCT06816823 | Recruiting Phase 1 DMC

• 1 other identifier: CHEC2025-028
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatic Cancer

Keywords

pancreatic cancer; CAR-NK

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (6)

• Objective response rate (ORR)

  42 days of first infusion

• Disease control rate (DCR)

  42 days of first infusion

• Progression-free survival (PFS)

  6 months

• Overall survival (OS)

  6 months

• Patient-reported quality of life (QoL)

  42 days of first infusion

Study Arms (1)

CL-NK-001

EXPERIMENTAL

Dose escalation of at least 3 dose levels

Biological: CL-NK-001

Interventions

CL-NK-001 BIOLOGICAL

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).

CL-NK-001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Zhuan Liao, MD PhD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Xuetao Cao, MD PhD

  National Key Laboratory of Immunity & Inflammation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanfang Liu, MD PhD

CONTACT

+86-13124828854; liuyanfang00215@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 10, 2025
• Study Start: April 7, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)