Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196255
Status:
RECRUITING
Last Update Posted:
2024-01-09
First Post:
2023-12-25
Brief Title:
Safety and Efficacy of Anti-FcRL5 CAR-T Cell Therapy in Treating Relapsed and Refractory Multiple Myeloma RR MM
Sponsor:
Xuzhou Medical University
Organization:
Xuzhou Medical University
Study Overview
Official Title:
Efficacy and Safety Study of Anti-FcRL5 CAR-T Cells in Subjects With Relapsed and Refractory Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2023-12
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 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma A leukapheresis procedure will be performed to manufacture Anti-FcRL5 chimeric antigen receptor CAR modified T cells Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide
Detailed Description:
This open label single-arm Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma A leukapheresis procedure will be performed to manufacture Anti-FcRL5 chimeric antigen receptor CAR modified T cells Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide 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