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RECRUITING Phase 2 ClinicalTrials.gov

Tocilizumab for Acute Chest Syndrome

Sponsor: University of Chicago • ClinicalTrials.gov ID: NCT05640271

Registry updated: 2026-09-15
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Description

The investigators are evaluating the role of a low dose of tocilizumab in treating acute chest syndrome in patients with sickle cell disease. Tocilizumab inhibits interleukin-6 (IL-6) receptors and is used to treat rheumatoid arthritis and severe cytokine release syndrome, which can be seen with chimeric antigen receptor T-cell (CAR-T) therapy, and it is also authorized for treatment of COVID-19. Since IL-6 levels are elevated in the sputum of patients with acute chest syndrome, the investigators are hopeful that this will be an effective strategy. The investigators will be looking at how a low dose of tocilizumab affects oxygen status, clinical outcomes, and laboratory markers in patients admitted to the hospital with acute chest syndrome.

Interventions

  • Tocilizumab (Drug)
    Tocilizumab 80 mg IV dose (one time per patient)

Eligibility criteria

Inclusion Criteria: * Adults ≥ 12 years of age * Prior diagnosis of sickle cell disease (Hb SS, Hb SC, Hb Sb+, and Hb Sb0) Exclusion Criteria: * Pregnant patients or breastfeeding mothers. * Prior treatment with gene therapy or a stem cell transplant. * Current enrollment in a clinical trial involving an FDA-regulated drug or biologic. * Current neutropenia (absolute neutrophil count \< 1000/mm\^3) * Current thrombocytopenia (platelet count \< 50,000 mm\^3) * Aspartate aminotransferase (AST) or alanine transaminase (ALT) \> 10 times the upper limit of normal (ULN) * History of tuberculosis (TB). * Positive purified protein derivative (PPD) TB screening test. * On active therapy with a Bruton's tyrosine kinase-targeted agent, which include the following: Acalabrutinib, Ibrutinib, Zanubrutinib * On active therapy with a JAK2-targeted agent, which include the following: Baricitinib, Ruxolitinib, Tofacitinib, Upadacitinib * Any of the following biologic immunosuppressive agent (and any biosimilar versions thereof) administered in the past 6 months: Abatacept, Adalimumab, Alemtuzumab, Atezolizumab, Belimumab, Blinatumomab, Brentuximab, Certolizumab, Daratumumab, Durvalumab, Eculizumab, Elotuzumab, Etanercept, Gemtuzumab, Golimumab, Ibritumomab, Infliximab, Inotuzumab, Ipilimumab, Ixekizumab, Moxetumomab, Nivolumab, Obinutuzumab, Ocrelizumab, Ofatumumab, Pembrolizumab, Polatuzumab, Rituximab, Sarilumab, Secukinumab, Tocilizumab, Tositumumab, Tremelimumab, Urelumab, Ustekinumab

Conditions

Sickle Cell Disease Acute Chest Syndrome

Locations

  • University of Chicago — Chicago, Illinois, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record