Using CAR-NK cells to treat pancreatic cancer

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

This study is testing a new treatment using CAR-NK cells to see if it can help people with advanced pancreatic cancer who haven't had success with other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT06816823 on ClinicalTrials.gov

What this trial studies

This is a first-in-human, open-label, dose-escalation study evaluating the safety, tolerability, and efficacy of CAR-NK cells (CL-NK-001) in patients with locally advanced, metastatic, or recurrent pancreatic cancer. The study aims to determine the appropriate dosing and assess the response of patients who have not responded to standard treatments. Participants will be monitored for adverse effects and treatment outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced pancreatic cancer who have failed or are intolerant to standard treatments.

Not a fit: Patients with central nervous system involvement or those who have received prior adoptive cell therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer who have limited treatment choices.

How similar studies have performed: While CAR-NK cell therapies are a novel approach, similar studies in other cancers have shown promising results, indicating potential for success in this area.

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.

Where this trial is running

Shanghai

• Changhai Hospital — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Zhuan Liao, MD PhD — Changhai Hospital
• Study coordinator: Yanfang Liu, MD PhD

Conditions Pancreatic Cancer; pancreatic cancer; CAR-NK