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Recruiting Phase 1 NCT06447376

Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab

Trial Parameters

Condition Non-Hodgkin Lymphoma
Sponsor Taylor Brooks
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 20
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-01-14
Completion 2028-09-01
Interventions
SiltuximabEpcoritamab

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.

Eligibility Criteria

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 anti-CD20 monoclonal antibody - containing therapy * FL grade 1-3A previously treated with at least 2 lines of systemic antineoplastic therapy, including at least 1 anti-CD20 monoclonal antibody - containing therapy. * At least 1 risk factor for cytokine release syndrome, including: * Age ≥ 65 years, * Elevated lactate dehydrogenase, * White blood cell count pre-anti-CD20 treatment \> 4.5x109 cells/L, * Ann Arbor Stage III/IV, * Sum of the product of the perpendicular diameters at study entry ≥3000mm2, * Cardiac comorbidity, including prior coronary disease, heart failure and other conditions that in the opinion of the investigator would increase the risk of heightened toxicity from CRS * Bone

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