CAR-NK cell therapy (CL-NK-003) for pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label, first-in-human Phase 1 fixed-dose trial gives CL-NK-003 CAR-NK cells to adults with locally advanced, metastatic, or recurrent pancreatic cancer. Patients must have tumor membrane eGR1 expression >40% with intensity ≥2+ and at least one measurable lesion by RECIST 1.1, and must have failed or been intolerant of standard therapy. The primary focus is on safety and tolerability, with secondary collection of preliminary anti-tumor activity and biomarker data. Key exclusions include central nervous system involvement and prior adoptive cell therapy, and participants must meet baseline blood and organ-function requirements.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\. Aged 18-75 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. Regular use of systemic corticosteroids within 2 weeks prior to screening at a dose exceeding prednisone 10 mg/day (or equivalent) on any day; 8. 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);9. Possible severe adverse events, allergy or other contraindications to drugs or its component under study;10. Pregnant or lactating women;11. History of neurological or psychological disorders;12. Not suitable to participate this clinical study judged by the investigator.

Where it's running

• Changhai Hospital
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Zhuan Liao — Changhai Hospital
• Study coordinator: Xuetao Cao
• Email: caoxt@immunol.org
• Phone: +86-13124828854

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Using contrast-enhanced ultrasound to check for local pancreatic cancer recurrence after surgery

  This pilot test uses contrast-enhanced ultrasound to see if it can help detect return of pancreatic cancer after surgery in patients being watched with CT scans.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania · NCT07910383

• Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

  This study tests whether adding ivermectin to standard preventive skin care helps people with pancreatic cancer who develop skin side effects from daraxonrasib.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07895498

• Becotatug Vedotin Plus Anti-PD-1 and S-1 in EGFR-Positive Advanced Pancreatic Cancer

  This study tests a three-drug regimen (becotatug vedotin, an anti-PD-1 therapy, and S-1) in adults with EGFR-positive advanced pancreatic cancer who have not responded to at least one prior therapy.

  Recruiting Ningbo Medical Center Lihuili Hospital · Ningbo, Zhejiang · NCT07892573

• Blood protein biomarkers to help diagnose pancreatic cancer in adults

  This study tests whether blood protein biomarkers can help detect pancreatic ductal adenocarcinoma and tell it apart from chronic pancreatitis and mucinous pancreatic lesions, and whether combining markers with CA 19-9 improves accuracy.

  Recruiting Grigore T. Popa University of Medicine and Pharmacy · Iași · NCT07875582

• Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Cancer (Phase 1)

  This early-stage study tests whether giving Lm-LLO-TT directly into the belly with low-dose gemcitabine is safe and tolerable for adults with previously treated, unresectable or metastatic pancreatic cancer.

  Recruiting Phase 1 Matter Bio, Inc. · The Bronx, New York · NCT07828236

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.