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| Name | Class |
|---|---|
| National Key Laboratory of Immunity and Inflammation | UNKNOWN |
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This is a single-center, open-label, first-in-human, fixed-dose study in patients with pancreatic cancer.
A fixed-dose study will evaluate the safety, tolerability and efficacy of CAR-NK cells (CL-NK-003) in patients with locally advanced, metastatic, or recurrent pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL-NK-003 | Experimental | Fixed-dose for at least 6 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CL-NK-003 | Biological | Fixed-dose (3 × 10^9 cells) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Safety | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Efficacy | 42 days of first infusion |
| Disease control rate (DCR) | Efficacy | 42 days of first infusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuetao Cao | Contact | +86-13124828854 | caoxt@immunol.org |
| Name | Affiliation | Role |
|---|---|---|
| Zhuan Liao | Changhai Hospital | Principal Investigator |
| Xuetao Cao | National Key Laboratory of Immunity & Inflammation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Recruiting | Shanghai | 200433 | China |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |