Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
DRUGiNKT
iNKT: Intravenous infusion, 0.5×10\^8cell-3.0×10\^8 cell
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Voluntarily participate in clinical research; Fully understand this study and voluntarily sign the informed consent form; Willing to follow and capable of completing all the test procedures; * 2\. Male or female, aged 18 to 75 years old (including the boundary value); * 3\. Patients with locally advanced or metastatic pancreatic cancer confirmed by histology or cytology. Patients with locally advanced or metastatic pancreatic cancer that cannot be surgically resected and have failed standard first - or second-line treatments, or have intolerable toxic and side effects of the existing standard treatments, or are not applicable to standard treatments at the present stage, or refuse standard treatments; * 4\. According to RECIST version 1.1, there is at least one evaluable tumor lesion; * 5\. The toxic reactions caused by previous anti-tumor treatment were relieved to grade 0-1 (according to NCI CTCAE version 5.0) or to an acceptable level of the inclusion/
Exclusion criteria
. Except for other toxicities such as hair loss and vitiligo that researchers consider not to pose a safety risk to the subjects; * 6\. Have sufficient organ functions; * 7\. The physical condition score of the Eastern Cooperative Oncology Group (ECOG) in the United States was 0-1; * 8\. The expected survival period is more than 3 months; * 9\. Premenopausal female subjects had negative blood pregnancy results before the start of the study treatment and were willing to abstain from sex or take medically recognized effective contraceptive measures (such as intrauterine devices, condoms) within 6 months from the signing of the informed consent form until the end of the last infusion; * 10\. Male subjects are willing to abstain from sexual activity or take medically recognized effective contraceptive measures for 6 months from the date of signing the informed consent form until the end of the last infusion, and not donate sperm during this period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | After 28 days of infusion | Safety |
| Maximum tolerated dose (MTD) | After 28 days of infusion | tolerability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antitumor efficacy-Duration of response (DOR) | About 2 years | The period from the first evaluation of CR or PR to the first evaluation of PD(Progressive Disease) or death of any cause. |
| Antitumor efficacy-Disease control rate (DCR) | About 2 years | 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 (%). |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | About 2 years | 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. |
| Antitumor efficacy-Overall survival (OS) | About 2 years | The period from the first infusion to any cause of death |
| Antitumor efficacy-Progression-free survival (PFS) | About 2 years | 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. |
| Antitumor efficacy-Objective response rate (ORR) | About 2 years | 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 |
Contacts
Primary ContactJiang Long, MD
Outcome results
None listed