Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447376
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-06-03
Brief Title:
Study of Cytokine Release Syndrome Prophylaxis and Treatment with Siltuximab Prior to Epcoritamab
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Pilot Safety-feasibility Study of Cytokine Release Syndrome Prophylaxis and Treatment with Siltuximab Prior to Epcoritamab
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
The goal of this clinical trial is to is to determine the safety feasibility and efficacy of siltuximab prophylaxis of cytokine release syndrome and neurotoxicity occurring after epcoritamab subcutaneous administration for participants with large b-cell lymphoma DLBCL or follicular lymphoma FL
Participants will receive siltuximab prior to the injection of epcoritamab Epcoritamab is administered in 28 day cycles for one year After this injection the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days
Participants will receive siltuximab prior to the injection of epcoritamab Epcoritamab is administered in 28 day cycles for one year After this injection the physician will continue to watch participants for side effects and follow the condition for a minimum of 60 days
Detailed Description:
Siltuximab is a monoclonal antibody that blocks interleukin-6 IL-6 from binding to its receptor preventing it from acting IL-6 is a cytokine a type of protein that is a cause of inflammatory reactions Decreasing levels of IL-6 has been shown to reduce symptoms of cytokine release syndrome CRS a potential side effect of epcoritamab Addition of siltuximab to the medications given before epcoritamab may prevent or reduce the severity of CRS Siltuximab is experimental because it is not approved by the Food and Drug Administration Epcoritamab is a so-called bispecific antibody which is a molecule that can bind simultaneously to two different receptors Epcoritamab binds to a receptor called CD3 with one part of the antibody and to a receptor called CD20 with another part of the antibody CD20 is expressed on the normal healthy B cells but also on the cancerous lymphoma cells of B cell origin CD3 is expressed on T cells which are important cells of the immune system and help the body fight cancers infections etc By simultaneous binding to CD3 and CD20 Epcoritamab brings T cells and B cells close together and activates the T cells to kill the B cells including the cancerous ones
Epcoritamab is experimental because it is not approved by the Food and Drug Administration FDA to treat participants with Follicular Lymphoma
Epcoritamab is experimental because it is not approved by the Food and Drug Administration FDA to treat participants with Follicular Lymphoma
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