Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352866
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-02
Brief Title:
Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w Teclistamab in RRMM
Sponsor:
Jack Khouri
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to Treatment With Teclistamab in Relapsed or Refractory Multiple Myeloma RRMM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
The purpose of this study is to examine the safety efficacy and feasibility of the use of one standard dose of siltuximab prior to teclistamab infusion Siltuximab is an investigational experimental drug that works by binding directly to human interleukin-6 IL-6 IL-6 is a cytokine these are products that are secreted by certain cells of the immune system and effect other cells in participants body IL-6 regulates immune inflammatory and metabolic processes Siltuximab has already been tested and approved for use by the FDA in participants with a condition called multicentric Castlemans disease which is a lymphoproliferative disorder This study is being conducted to investigate if administration of a single dose of siltuximab will reduce the rates of and severity of Cytokine Release Syndrome CRS and Immune effector Cell-Associated Neurotoxicity Syndrome ICANS in participants prior to teclistamab administration CRS and ICANS are adverse effects commonly experienced by participants being treated with teclistamab that are related to inflammation in the body Siltuximab is experimental because it is not approved by the Food and Drug Administration FDA for prophylactic use prior to administration of teclistamab infusion
Detailed Description:
Cytokine release syndrome CRS and immune effector cell-associated neurotoxicity ICANS are clinically relevant toxicities of bsAbs and other T cell redirecting therapies The armamentarium of immunotherapeutic approaches is expected to grow at exponential rates in the upcoming years with an expansion of the diseases treated with this modality
While the risk of CRS and ICANS is limited with most bsAbsbispecific antibodies these side effects can prevent a more widespread adoption of these therapies and impede their use in participants for whom access to tertiary or quaternary medical centers is limited
The development of strategies that prevent CRS and ICANS occurring after bispecific antibodies can increase the prescription of these effective immunotherapies in particular for participants for whom access to care is limited
Siltuximab is a chimeric murine antibody that binds directly to IL-6 and has been used effectively in the treatment of CRS with guidelines recommending its use in CRS cases refractory to tocilizumab
Study hypothesis is that through direct binding of IL-6 siltuximab can overcome the risk of increased IL-6 - mediated ICANS by decreasing the available IL-6 for blood brain barrier passage and by facilitating clearance of IL-6 through IL-6 receptor-mediated mechanisms
Based on this rationale a phase II study investigating the use of siltuximab for CRS and ICANS prophylaxis prior to therapy with the BCMAxCD3 bispecific antibody teclistamab
This study will examine the safety efficacy and feasibility of the use of standard doses of siltuximab prior to teclistamab infusion and will determine the rates of all grades as well as grade 2 or higher CRS and ICANS in participants given prophylaxis prior to teclistamab which has well defined rates of CRS and ICANS This will allow for a preliminary assessment of the efficacy of siltuximab as preventive measure against CRS and ICANS
While the risk of CRS and ICANS is limited with most bsAbsbispecific antibodies these side effects can prevent a more widespread adoption of these therapies and impede their use in participants for whom access to tertiary or quaternary medical centers is limited
The development of strategies that prevent CRS and ICANS occurring after bispecific antibodies can increase the prescription of these effective immunotherapies in particular for participants for whom access to care is limited
Siltuximab is a chimeric murine antibody that binds directly to IL-6 and has been used effectively in the treatment of CRS with guidelines recommending its use in CRS cases refractory to tocilizumab
Study hypothesis is that through direct binding of IL-6 siltuximab can overcome the risk of increased IL-6 - mediated ICANS by decreasing the available IL-6 for blood brain barrier passage and by facilitating clearance of IL-6 through IL-6 receptor-mediated mechanisms
Based on this rationale a phase II study investigating the use of siltuximab for CRS and ICANS prophylaxis prior to therapy with the BCMAxCD3 bispecific antibody teclistamab
This study will examine the safety efficacy and feasibility of the use of standard doses of siltuximab prior to teclistamab infusion and will determine the rates of all grades as well as grade 2 or higher CRS and ICANS in participants given prophylaxis prior to teclistamab which has well defined rates of CRS and ICANS This will allow for a preliminary assessment of the efficacy of siltuximab as preventive measure against CRS and ICANS
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