Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Clinical Study on the Safety and Efficacy of CAR-TCAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study on the Safety and Efficacy of CAR-TCAR-NK Cells in the Treatment of Recurrent Refractory or Unresectable Solid Tumors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the safety and efficacy of CAR-TCAR-NK cells in patients with recurrent or unresectable solid tumors including pancreatic cancer prostate cancer breast cancer glioma etc
Detailed Description:
To investigate the safety and efficacy of CAR-TCAR-NK cells in patients with recurrent or unresectable solid tumors including pancreatic cancer prostate cancer breast cancer glioma etc
The study was divided into five stages screening period single harvest period pretreatment chemotherapy period treatment period observation and follow-up period after treatment
Subjects were pretreated with FC regimen before transfusion and the subjects who met the infusion conditions were given CAR-TCAR-NK cell infusion 1 2 days after the completion of eluent chemotherapy The CAR-TCAR-NK dose is calculated according to the patients body weight and the total number of cells transfused is about 1-2x106 kg Single intravenous infusion
The efficacy was evaluated according to the evaluation criteria for solid tumors RECIST11 selection
The study was divided into five stages screening period single harvest period pretreatment chemotherapy period treatment period observation and follow-up period after treatment
Subjects were pretreated with FC regimen before transfusion and the subjects who met the infusion conditions were given CAR-TCAR-NK cell infusion 1 2 days after the completion of eluent chemotherapy The CAR-TCAR-NK dose is calculated according to the patients body weight and the total number of cells transfused is about 1-2x106 kg Single intravenous infusion
The efficacy was evaluated according to the evaluation criteria for solid tumors RECIST11 selection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None