Clinical trial · Interventional
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
NCT06816823CI-TRIAL-00090582recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CL-NK-001 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CL-NK-001
- description
- Dose escalation of at least 3 dose levels
- interventionNames
- Biological: CL-NK-001
Primary outcomes (6)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- 42 days of first infusion
- description
- Safety
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- 42 days of first infusion
- description
- Tolerability
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.