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

ConditionsNon-Hodgkin LymphomaCytokine Release Syndrome
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTaylor Brooks

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Primary mediastinal B cell lymphoma

Active central nervous system or meningeal involvement by lymphoma

History of severe allergic or anaphylactic reactions to anti-CD20 monoclonal antibody therapy

Active bacterial, viral, fungal, mycobacterial, parasitic or other infection requiring systemic therapy within 2 weeks prior to first dose of study drug. This includes participants with COVID-19 infection

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

  • Gemcitabine and oxaliplatin

    Drug

    Starting on Cycle 2, participants may receive the addition of GemOx. Participants receive 1,000 milligrams/meter\^2 (mg/m\^2) of GemOx on Days 1 and 15 of Cycle 2 and onwards.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Prophylactic siltuximab + epcoritamabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of all-grade cytokine release syndrome

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.

Time frame
Up to 28 days after beginning treatment

Secondary outcomes

1

Incidence of grade ≥ 2 cytokine release syndrome

A secondary objective is to determine the incidence of grade ≥ 2 CRS after siltuximab prophylaxis

Time frame
Up to 28 days after beginning treatment
2

Incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis

A secondary objective is to determine the incidence of all grade and grade ≥ 2 ICANS after siltuximab prophylaxis

Time frame
Up to 28 days beginning treatment
3

Incidence of adverse events during Cycle 1 (Day 1 - 28)

A secondary objective is to describe the adverse events after siltuximab prophylaxis.

Time frame
Up to 28 days after beginning treatment
4

Best overall and complete response rates

A secondary objective is to describe the disease response rates (overall and complete response rates) to epcoritamab in participants treated with prophylactic siltuximab, based on Lugano response criteria for malignant lymphomas, which can include complete response (CR), partial response (PR), stable disease (SD), progression (PD) and relapse.

Time frame
Up to 456 days after beginning treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taylor Brooks

Lead sponsor

Case Comprehensive Cancer Center

Sponsor institution

Genmab

Collaborator

AbbVie

Collaborator

RECORDATI GROUP

Collaborator

Source ClinicalTrials.gov
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