Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM : Phase II Trial of Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to Treatment With Teclistamab in Relapsed or Refractory Multiple Myeloma (RRMM)
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 bsAbs(bispecific 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..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 16. Apr. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: April 8, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 |
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| Study ID: |
NCT06352866 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG00967103X |
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| 245 | 1 | 0 | |a Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to tx w/ Teclistamab in RRMM |b Phase II Trial of Siltuximab for Cytokine Release Syndrome Prophylaxis Prior to Treatment With Teclistamab in Relapsed or Refractory Multiple Myeloma (RRMM) |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: April 8, 2024, Last downloaded: ClinicalTrials.gov processed this data on April 24, 2024, Last updated: April 24, 2024 | ||
| 520 | |a 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 bsAbs(bispecific 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. | ||
| 650 | 2 | |a Multiple Myeloma | |
| 650 | 2 | |a Neoplasms, Plasma Cell | |
| 650 | 2 | |a Neurotoxicity Syndromes | |
| 650 | 2 | |a Syndrome | |
| 650 | 2 | |a Cytokine Release Syndrome | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Not yet recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
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