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To evaluate the preliminary safety and tolerability of iNKT cell injection after infusion in each group of subjects, and to determine the maximum tolerated dose (MTD) and/or the recommended dose for extended studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iNKT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iNKT | Drug | iNKT: Intravenous infusion, 0.5×10^8cell-3.0×10^8 cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Safety | After 28 days of infusion |
| Maximum tolerated dose (MTD) | tolerability | After 28 days of infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Adverse events up to 12 months of follow-up visit judged by the investigator to be associated with iNKT cell infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc. | About 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Long, MD | Contact | 86+18017317460 | jiang.long@shgh.cn |
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| Antitumor efficacy-Objective response rate (ORR) |
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR |
| About 2 years |
| Antitumor efficacy-Duration of response (DOR) | The period from the first evaluation of CR or PR to the first evaluation of PD(Progressive Disease) or death of any cause. | About 2 years |
| Antitumor efficacy-Disease control rate (DCR) | The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%). | About 2 years |
| Antitumor efficacy-Progression-free survival (PFS) | The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first. | About 2 years |
| Antitumor efficacy-Overall survival (OS) | The period from the first infusion to any cause of death | About 2 years |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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