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The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.
This study is a single-arm, open-label, modified "3+3" dose-escalation exploratory study. The BGT007H cell therapy group will be evaluated at 5 dose levels, which are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. If a lower adverse reaction and preliminary benefit (SD or PR) are observed, the same dose will be repeated 1-2 times after a 1-month interval.
Each subject will be observed for at least 4 weeks after cell infusion (DLT observation period). The first two dose groups (3.0×10^7, 1.0×10^8 cells) will each include 1 subject, and the remaining 3 dose groups will follow the conventional "3+3" dose-escalation method. If a DLT occurs in the first subject at the first dose level, an additional 5 subjects will be included. If no DLT occurs in the expanded subjects, the study will proceed to the next higher dose group. If another subject experiences a DLT, enrollment will be halted and the study protocol will be revised. The next subject can only be enrolled if it is confirmed that the previous subject did not experience grade 3 or higher adverse events related to the study drug (CTCAE 5.0) during the DLT observation period. If no DLT occurs in a dose group, the study will proceed to the next higher dose group. In a group of 3 subjects, if one experiences a DLT, an additional 3 subjects will be included in the next higher dose group. If one out of three subjects experiences a DLT, 3 more subjects will be included in the dose group. If only one out of the expanded 6 subjects experiences a DLT, then the study will proceed to include 3 more subjects at the next higher dose. If 2 or more out of the expanded 6 subjects experience a DLT, then the dose is considered to be higher than the MTD (MTD is defined as the highest dose at which ≤1/6 or ≤2/9 subjects experience a DLT). New subjects will be enrolled at the previous lower dose (tolerated dose) group until 6 or 9 subjects are reached in the lower dose group. If ≤1/6 or ≤2/9 subjects, this lower dose group is defined as the MTD or the optimal effective dose. During the study, the investigators may consider the safety and preliminary efficacy data of the enrolled subjects, with the safety of the subjects and the maximum benefit of the disease as the premise, and conduct the study treatment at the maximum tolerated dose or other doses determined by the investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGT007H Cell Injection | Experimental | A modified "3+3" dose-escalation design is used, with BGT007H cells administered at five progressively increasing dose levels for treatment evaluation. The dose levels are (3.0×10^7, 1.0×10^8, 2.0×10^8, 3.0×10^8, 4.0×10^8) BGT007H cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGT007H Cell Injection | Drug | Intervention roughly goes through 3 phases (the day of cell infusion is defined as day 0, d0):
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | Dose-Limiting Toxicity | through study completion, an average of 3 year |
| Maximum Tolerated Dose (MTD) | Maximum Tolerated Dose | through study completion, an average of 3 year |
| Optimal Biological Dose (OBD) | Optimal Biological Dose | through study completion, an average of 3 year |
| Adverse events (AE) | Adverse events | through study completion, an average of 3 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the disease control rate (DCR) | Evaluate the disease control rate ,according to the RECIST 1.1 criteria. | through study completion, an average of 3 year |
| Evaluate the duration of response (DOR) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the overall survival (OS) | Evaluate the overall survival ,according to the RECIST 1.1 criteria. | through study completion, an average of 3 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiuqi Wu, Doctorate | Contact | 15850459057 | wuxiuqi597@163.com | |
| Jiujie Cui, Doctorate | Contact | 13621958524 | cuijiujie@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liwei Wang, Doctorate | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital | Recruiting | Shanghai | Shanghai Municipality | 200127 | 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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|
Evaluate the duration of response ,according to the RECIST 1.1 criteria.
| through study completion, an average of 3 year |
| Evaluate the progression-free survival (PFS) | Evaluate the progression-free survival, according to the RECIST 1.1 criteria. | through study completion, an average of 3 year |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |