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

NCT ID: NCT06816823

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CL-NK-001

Dose escalation of at least 3 dose levels

Group Type: EXPERIMENTAL

CL-NK-001

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Changhai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Liao

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhuan Liao, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Xuetao Cao, MD PhD

Role: PRINCIPAL_INVESTIGATOR

National Key Laboratory of Immunity & Inflammation

Locations

Changhai Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanfang Liu, MD PhD

Role: CONTACT

liuyanfang00215@163.com

+86-13124828854

Facility Contacts

Yanfang Liu, MD PhD

Role: primary

liuyanfang00215@163.com

+86-13124828854

Other Identifiers

CHEC2025-028

Identifier Type: -

Identifier Source: org_study_id