Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-02 @ 12:22 AM
Study NCT ID:
NCT05284968
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2022-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RD07 Cell Injection in the Treatment of Patients With Advanced Claudin18.2 Positive Solid Tumors
Sponsor:
Peking University
Organization:
Study Overview
Official Title:
Clinical Study on the Safety and Efficacy of RD07 Cell Injection in the Treatment of Patients With Advanced Claudin18.2 Positive Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2021-12
Last Known Status:
NOT_YET_RECRUITING
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:
IP: RD07 cell injection; Target disease：solid tumor; Protocol design： Single arm, open label, dose increasing design. The experiment was divided into two stages: dose increasing stage and dose extension stage. After the completion of the dose escalation phase (9 or 12 cases) and the conclusion of safety, the investigator can select the appropriate dose group according to the safety, tolerance, and treatment response to enter the dose expansion phase. Dose extension stage (24 and 27 cases) according to the indications in the crowd into three queues: respectively for the integration of a stomach and the stomach esophagus adenocarcinoma, pancreatic cancer and other solid tumor, expand stage each queue number of cases can be determined by the actual filter and into the group of patients, no separate regulation, but two phase of the total case must not exceed 36 cases.
Detailed Description:
Principle of dose escalation:
1. If there is no DLT in 3 subjects in one dose group, increase to the next dose group;
2. If DLT occurs in only 1 of 3 subjects in a dose group, 3 subjects will be added to the dose group. If no more than 1 out of 6 subjects developed DLT, then increments to the next dose group;
3. If DLT occurs in ≥2 of 6 subjects, the level of the dose group exceeds MTD and should be reduced to the first dose group. If there were only 3 patients in the dose group, 3 more patients were enrolled. If this dose has been tested in 6 patients, the test is over and this dose is MTD;
4. If the dose increase to the highest dose group still does not reach MTD, the dose increase should be stopped.
Dose extension After the completion of the dose escalation phase (9 or 12 cases) and the conclusion of safety, the investigator can select the appropriate dose group according to the safety, tolerance, and treatment response to enter the dose expansion phase. Dose extension stage (24 and 27 cases) according to the indications in the crowd into three queues: respectively for the integration of a stomach and the stomach esophagus adenocarcinoma, pancreatic cancer and other solid tumor, expand stage each queue number of cases can be determined by the actual filter and into the group of patients, no separate regulation, but two phase of the total case must not exceed 36 cases.
Multiple infusion Efficacy was assessed as PR or SD lasting more than 12 weeks after the initial infusion, and subsequent infusion could be considered if patients developed disease progression. The pretreatment plan before the second infusion is the same as the first pretreatment. The researcher can decide whether to preprocess and adjust the pretreatment plan according to the specific situation of the subjects. Re-infusion can be performed 48 hours after the completion of the re-infusion, and the follow-up nodes after the re-infusion are the same as the treatment cycle of the first infusion. If the efficacy evaluation of the subjects is still PD after the re-infusion, RD07 infusion will not be performed later.
1. If there is no DLT in 3 subjects in one dose group, increase to the next dose group;
2. If DLT occurs in only 1 of 3 subjects in a dose group, 3 subjects will be added to the dose group. If no more than 1 out of 6 subjects developed DLT, then increments to the next dose group;
3. If DLT occurs in ≥2 of 6 subjects, the level of the dose group exceeds MTD and should be reduced to the first dose group. If there were only 3 patients in the dose group, 3 more patients were enrolled. If this dose has been tested in 6 patients, the test is over and this dose is MTD;
4. If the dose increase to the highest dose group still does not reach MTD, the dose increase should be stopped.
Dose extension After the completion of the dose escalation phase (9 or 12 cases) and the conclusion of safety, the investigator can select the appropriate dose group according to the safety, tolerance, and treatment response to enter the dose expansion phase. Dose extension stage (24 and 27 cases) according to the indications in the crowd into three queues: respectively for the integration of a stomach and the stomach esophagus adenocarcinoma, pancreatic cancer and other solid tumor, expand stage each queue number of cases can be determined by the actual filter and into the group of patients, no separate regulation, but two phase of the total case must not exceed 36 cases.
Multiple infusion Efficacy was assessed as PR or SD lasting more than 12 weeks after the initial infusion, and subsequent infusion could be considered if patients developed disease progression. The pretreatment plan before the second infusion is the same as the first pretreatment. The researcher can decide whether to preprocess and adjust the pretreatment plan according to the specific situation of the subjects. Re-infusion can be performed 48 hours after the completion of the re-infusion, and the follow-up nodes after the re-infusion are the same as the treatment cycle of the first infusion. If the efficacy evaluation of the subjects is still PD after the re-infusion, RD07 infusion will not be performed later.
Study Oversight
Has Oversight DMC:
True
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?: