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Siltuximab · 1 trial · 2 indications
The primary objective is to evaluate the feasibility and efficacy of prophylactic administration of siltuximab prior to infusion of the first dose of epcoritamab with the purpose of preventing all-grade CRS, as measured by incidence of all-grade cytokine release syndrome.
| Arm | Type | Description |
|---|---|---|
| Prophylactic siltuximab + epcoritamab | EXPERIMENTAL | Siltuximab Administration: • Participants will receive a single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. There is no planned dose escalation of siltuximab and epcoritamab dosing will be done following the standard planned ramp-up over the course of the first 3 weeks Epcoritamab Infusion: • The treatment regimen of epcoritamab is done in 28-day cycles. Epcoritamab is to be administered by subcutaneous injection. Participants can be treated for up to 24 cycles. Participants who achieve complete remission at the time of their disease response assessment after 12 cycles may be considered for early discontinuation of treatment. |
| Name | Type | Description |
|---|---|---|
| Siltuximab | DRUG | Single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab. |
| Epcoritamab | DRUG | Epcoritamab dosing for Diffuse Large B-cell Lymphoma Participants: * Cycle 1, Day 1 = 0.16mg * Cycle 1, Day 8 = 0.8mg * Cycle 1, Day 15 = 48mg * Cycle 1, Day 22 = 48mg * Cycles 2 \& 3, Day 1 = 48mg * Cycles 2 \& 3, Day 8 = 48mg * Cycles 2 \& 3, Day 15 = 48mg * Cycles 2 \& 3, Day 22 = 48mg * Cycles 4-9, Day 1 = 48mg * Cycles 4-9, Day 15 = 48mg * Cycle 10+ , Day 1 = 48mg Epcoritamab dosing for Follicular Lymphoma Participants: * Cycle 1, Day 1 = 0.16mg * Cycle 1, Day 8 = 0.8mg * Cycle 1, Day 15 = 3mg * Cycle 1, Day 22 = 48mg * Cycle 2 \& 3, Day 1 = 48mg * Cycle 2 \& 3, Day 8 = 48mg * Cycle 2 \& 3, Day 15 = 48mg * Cycle 2 \& 3, Day 22 = 48mg * Cycle 4-9, Day 1 = 48mg * Cycle 4-9, Day 15 = 48mg * Cycle 10+ , Day 1 = 48mg |
Inclusion Criteria: * Adults 18 years of age and older * Diagnosis of non-Hodgkin lymphoma. * DLBCL (including high grade B cell lymphoma and follicular lymphoma grade 3B and transformed follicular lymphoma) treated with at least 2 lines of systemic antineoplastic therapies, including at least 1...
Siltuximab is being studied for use in Non-Hodgkin Lymphoma, specifically as prophylaxis and treatment for cytokine release syndrome prior to treatment with epcoritamab. It is currently in Phase 1 clinical development and is investigational, meaning it is not yet approved for this use.
Siltuximab is a monoclonal antibody (a -mab) that targets interleukin-6 (IL-6). By binding to IL-6, it is intended to block its activity, which may help prevent or treat cytokine release syndrome in patients with Non-Hodgkin Lymphoma receiving certain therapies.
Siltuximab is being developed by Genmab A/S, a biopharmaceutical company traded under the ticker GMAB. The company is conducting a Phase 1 clinical trial to evaluate the drug in Non-Hodgkin Lymphoma patients.
Siltuximab is in Phase 1 clinical development for Non-Hodgkin Lymphoma. It is an investigational drug and has not been approved by regulatory authorities for this indication. The ongoing trial is currently recruiting participants in the United States.
Siltuximab is being evaluated in a single Phase 1 clinical trial with the identifier NCT06447376. The study, titled 'Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab,' is recruiting 20 participants with Non-Hodgkin Lymphoma and cytokine release syndrome in the United States.
Siltuximab is a distinct monoclonal antibody and is not known by other names in the context of this development program. It is being studied specifically for its role in managing cytokine release syndrome in Non-Hodgkin Lymphoma patients treated with epcoritamab.