Study of Siltuximab for Cytokine Release Syndrome in Non-Hodgkin Lymphoma
This study is looking at whether a drug called siltuximab can help prevent or reduce a side effect called Cytokine Release Syndrome (CRS) when given before another drug, epcoritamab, in people with Non-Hodgkin Lymphoma. CRS is an inflammatory reaction that can happen with certain cancer treatments. Siltuximab works by blocking a protein that causes inflammation. Epcoritamab is a bispecific antibody that helps your immune system fight lymphoma cells. The study aims to see how safe and effective this approach is. You might be able to join if you are between 18 and 65 years old and have certain types of Non-Hodgkin Lymphoma, like Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL), that has been treated before. The main goal is to see how often CRS occurs within 28 days of starting treatment. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 20 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will receive a single dose of siltuximab before epcoritamab. Epcoritamab is given in 28-day cycles for one year. Some participants may also receive gemcitabine and oxaliplatin starting in Cycle 2.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for side effects and your condition for at least 60 days after treatment, with the primary endpoint measured up to 28 days after beginning treatment.
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NCT06447376
Study of Cytokine Release Syndrome Prophylaxis and Treatment With Siltuximab Prior to Epcoritamab
Recruiting
PHASE1Ages 18–65InterventionalTreatmentTaylor BrooksInvestigator-initiated
~20 participants
Updated 2026-06-25 on ClinicalTrials.gov
What's tested:SiltuximabEpcoritamabGemcitabine and oxaliplatin
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of all-grade cytokine release syndrome
Measured over Up to 28 days after beginning treatment
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Taylor Brooks, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 marrow infiltration,
Circulating lymphoma cells in peripheral blood
Adequate bone marrow function including:
Hemoglobin ≥ 8g/dL (unless bone marrow involvement by lymphoma) (transfusion allowed for symptomatic participants),
Absolute neutrophil count cell count ≥1000 / μL, with or without growth factor support
Platelet counts ≥ 75,000 / μL (unless bone marrow involvement by lymphoma, in which case platelet counts ≥ 50,000 / µL are required)
ECOG performance status 0 - 2
Adequate renal function, defined as an estimated creatinine clearance ≥ 30 mL/min.
NOTE: Participants who will receive the addition of GemOx in cycle 2 must continue to exhibit an estimated creatinine clearance of ≥ 30 mL/min prior to initiation of these agents in cycle 2.
Adequate hepatic function:
AST and/or ALT up to 3 times upper limit of normal (unless elevation is secondary to disease involvement of the liver, in which case up to 5 times upper limit is permitted after discussion with the principal investigator).
Total bilirubin up to 1.5 times upper limit of normal (unless elevation is secondary to Gilbert syndrome or of non - hepatic origin).
Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \< 1% per year during the treatment period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\< 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
Exclusion
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
History of active chronic infection by hepatitis B or C or Cytomegalovirus (CMV) requiring treatment or prophylaxis. Resolved infections (either by treatment or immune response) are not exclusion criterion.
Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast). History of prior malignancy is not excluded.
HIV seropositivity.
Subjects with uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant or breastfeeding women are excluded from this study because siltuximab therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with siltuximab, breastfeeding should be continued and not restarted for 3 months after the last dose of siltuximab. These potential risks may also apply to other agents used in this study.
Participants with history of clinically relevant and active CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.
Peripheral neuropathy assessed to be Grade \>1 according to NCI CTCAE v5.0 at enrollment for participants anticipated to receive GemOx
What this trial measures
- Incidence of all-grade cytokine release syndromeUp to 28 days after beginning treatment
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.