Ignite Creation Date:
2024-07-17 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478225
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-05-06
Brief Title:
Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With RelapsedRefractory Pancreatic Cancer
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With RecurrentRefractory Pancreatic Cancer
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrentrefractory pancreatic cancer
Detailed Description:
This study is a single-arm open-label modified 33 dose-escalation exploratory study The BGT007H cell therapy group will be evaluated at 5 dose levels which are 30107 10108 20108 30108 40108 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 30107 10108 cells will each include 1 subject and the remaining 3 dose groups will follow the conventional 33 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 50 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 16 or 29 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 16 or 29 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
Each subject will be observed for at least 4 weeks after cell infusion DLT observation period The first two dose groups 30107 10108 cells will each include 1 subject and the remaining 3 dose groups will follow the conventional 33 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 50 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 16 or 29 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 16 or 29 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None