Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596057
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
Safety and Efficacy of CD19 CAR-TCAR-NK Cells
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Head of HematologyVice President and Secretary-General of Shandong Stem Cell Society
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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 CD19 CAR-TCAR-NK cells in patients with relapsedrefractory B-cell lymphoma and acute B-lymphoblastic leukemia
Detailed Description:
Patients who met the exclusion criteria were treated with advanced FC regimen and subjects who met the infusion criteria assessed by the investigators were given CAR-TCAR-NK cell infusion 1 to 2 days after completion of eluvial 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 study was divided into five stages screening period single harvest period pretreatment chemotherapy period treatment period observation and follow-up period after treatment
For lymphoma refer to the 2014 version of Lugano efficacy evaluation criteria
The study was divided into five stages screening period single harvest period pretreatment chemotherapy period treatment period observation and follow-up period after treatment
For lymphoma refer to the 2014 version of Lugano efficacy evaluation criteria
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