Siltuximab for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

Timothy VOORHEES | Assistant Professor ...

Overseen byTimothy J. Voorhees, MD, MSCR

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Timothy Voorhees

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I trial tests the safety and side effects of siltuximab in preventing CAR T cell therapy related cytokine release syndrome in patients with CD19 positive non-Hodgkin lymphoma. Several of the major complications of CD19 directed chimeric antigen receptor T-cell therapy (CD19.CAR-T) include cytokine release syndrome (CRS, a complication of a highly active immune system seen with some cancer treatments including CD19.CAR-T cell therapy) and immune effector cell therapy associated neurotoxicity (ICANS, neurologic complications related to an activated immune system seen with immunotherapy and CD19.CAR-T cell therapy). Siltuximab is a chimeric (having parts of different origins) murine (from mice) antibody that binds directly to IL-6 (a cytokine/ body chemical causing toxicities) and allows for its clearance. IL-6 is known to increase in a patient's blood after CD19.CAR-T cell infusion and has been associated with development of CRS and ICANS. Giving siltuximab prior to CD19.CAR-T cell therapy may help reduce CRS and/or ICANS after therapy.

Research Team

Timothy J. Voorhees, MD, MSCR

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Adults with CD19 positive non-Hodgkin lymphoma eligible for standard CAR-T cell therapy can join this trial. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception if of childbearing potential, and cannot have active central nervous system lymphoma or uncontrolled illnesses.

Inclusion Criteria

Aspartate aminotransferase (AST) =< 3.0 × ULN (obtained within 14 days prior to initiating study treatment)

I am eligible for a specific CAR-T cell therapy.

Hemoglobin >= 8.0 x 10^9/L (obtained within 14 days prior to initiating study treatment)

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Exclusion Criteria

I do not have active brain conditions like epilepsy, severe strokes, or Parkinson's.

I had a severe reaction to my first siltuximab infusion.

Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study and lactating females must agree to not breastfeed while taking study drugs)

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Treatment Details

Interventions

Siltuximab (Monoclonal Antibodies)

Trial OverviewThe trial is testing siltuximab's ability to prevent cytokine release syndrome (CRS) and neurotoxicity in patients undergoing CAR-T cell therapy. Siltuximab is an antibody that targets IL-6, a body chemical linked to these side effects.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (siltuximab, biospecimen)Experimental Treatment4 Interventions

Patients receive siltuximab IV prior to CE19.CAR-T cell therapy and as clinically indicated on study. Patients undergo CT scan or PET scan throughout the trial. Patients also undergo blood sample collection during screening and on study.