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

PHASE1RecruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 14, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

September 1, 2028

Conditions
Non-Hodgkin LymphomaCytokine Release Syndrome
Interventions
DRUG

Siltuximab

Single dose of prophylactic siltuximab, 11mg/kg, started 1 hour prior (+/- 60 minutes) to the infusion of epcoritamab.

DRUG

Epcoritamab

"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"

Trial Locations (1)

44195

RECRUITING

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Genmab

INDUSTRY

collaborator

AbbVie

INDUSTRY

collaborator

Recordati Rare Diseases

INDUSTRY

lead

Taylor Brooks

OTHER