Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05739227
Status:
RECRUITING
Last Update Posted:
2023-02-22
First Post:
2023-02-11
Brief Title:
Safety and Efficacy of Allogenic CD19-CAR-NK Cells in Treatmenting rr B-cell Hematologic Malignancies
Sponsor:
Xuzhou Medical University
Organization:
Xuzhou Medical University
Study Overview
Official Title:
Early Clinical Study of Allogenic CD19-CAR-NK Cells JD001 in the Treatment of Refractory or Relapsedrr B-cell Hematologic Malignancies
Status:
RECRUITING
Status Verified Date:
2023-02
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:
This is an open label single-arm Phase I study to evaluate the efficacy and safety of allogenic CD19-CAR-NK cells in subjects with refractory or relapsed B-cell hematologic malignancies A leukapheresis procedure will be performed to manufacture Anti-CD19 chimeric antigen receptor CAR modified NK cells Prior to allogenic CD19-CAR-NK cells infusion subjects will receive lymphodepleting therapy with fludarabine cyclophosphamide and etoposide
Detailed Description:
This open label single-arm Phase I study aims to evaluate the efficacy and safety of allogenic CD19-CAR-NK cells in subjects with refractory or relapsed B-cell hematologic malignancies A leukapheresis procedure will be performed to manufacture Anti-CD19 chimeric antigen receptor CAR modified NK cells Prior to allogenic CD19-CAR-NK cells infusion subjects will receive lymphodepleting therapy with fludarabine cyclophosphamide and etoposide After infusion the investigators will observe the characteristics of dose limited toxicity DLT and determine the maximum tolerable agent MTD and rp2d were confirmed To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials
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