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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Taylor Brooks
Study ID
NCT06447376
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Jan 14, 2025
Status verified
May 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prophylactic siltuximab + epcoritamab
    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.

Primary Outcome Measure

Incidence of all-grade cytokine release syndrome [ Time Frame: Up to 28 days after beginning treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195
Taylor Brooks, MD
[email protected]
866-223-8100

Find similar trials in Cleveland, OH

By research site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OH

Related Studies