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2025-04-07
2025-09
2025-12
30
NCT06816823
Changhai Hospital
Changhai Hospital
INTERVENTIONAL
CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
This is a single-center, open-label, first-in-human, dose-escalation study in patients with pancreatic cancer.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2025-02-01 | N/A | 2025-06-03 |
2025-02-06 | N/A | 2025-06-04 |
2025-02-10 | N/A | 2025-06 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: CL-NK-001 Dose escalation of at least 3 dose levels | BIOLOGICAL: CL-NK-001
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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 Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Efficacy | 42 days of first infusion |
| Disease control rate (DCR) | Efficacy | 42 days of first infusion |
| Progression-free survival (PFS) | Efficacy | 6 months |
| Overall survival (OS) | Efficacy | 6 months |
| Patient-reported quality of life (QoL) | Measured by the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (EORTC QLQ-C30) | 42 days of first infusion |
| Patient-generated subjective global assessment (PG-SGA) | Nutritional status measurement with a medical history section assessed by patients and a physical assessment section assessed by medical staff | 42 days of first infusion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Yanfang Liu, MD PhD Phone Number: +86-13124828854 Email: liuyanfang00215@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
