Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04864522
Status:
WITHDRAWN
Last Update Posted:
2023-11-21
First Post:
2021-03-30
Brief Title:
Phase III Study of SLAMF7 FPBMCCS-1 FPBMC in RelapsedRefractory Multiple Myeloma
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Phase III Study of Anti-CD3 x Anti-SLAMF7 Anti-CS-1 Bispecific Antibody Armed Fresh Peripheral Blood Mononuclear Cells SLAMF7 FPBMC in RelapsedRefractory Multiple Myeloma
Status:
WITHDRAWN
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual due to a crowded field of effective drugs by the time the study opened
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MM FPBMC
Brief Summary:
The purpose of this study is to understand the safety and estimate the efficacy of combining anti-CD3 x anti-SLAMF7 bispecific antibody fresh peripheral blood mononuclear cells SLAMF7 FPBMCCS1 FPBMC for patients with relapsed andor refractory multiple myeloma Patients receive 8 weekly doses and then 8 more doses every 2 weeks of SLAMF7 FPBMC by intravenous infusion
Detailed Description:
Once subjects are determined eligible white blood cells lymphocytes are collected via leukapheresis procedure The white blood cells specifically T cells are then mixed with two proteins OKT3 and IL-2 which activate the cells to multiply
The activated T cells are coated with the OKT3 and elotuzumab an anti-SLAMF7 drug to produce bispecific fresh peripheral blood mononuclear cells FPBMC
About 72 hours after the leukapheresis procedure SLAMF7 FPBMC infusions will start After about 8-9 weeks participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses Before throughout and following SLAMF7 FPBMC research blood will be collected to better understand immune response Disease status will be checked regularly during and after study treatment
The activated T cells are coated with the OKT3 and elotuzumab an anti-SLAMF7 drug to produce bispecific fresh peripheral blood mononuclear cells FPBMC
About 72 hours after the leukapheresis procedure SLAMF7 FPBMC infusions will start After about 8-9 weeks participants will have another leukapheresis procedure and then receive doses every 2 weeks for 8 more doses Before throughout and following SLAMF7 FPBMC research blood will be collected to better understand immune response Disease status will be checked regularly during and after study treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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