Siltuximab In Siltuximab-RElapsed/REfractory Multicentric CAstleman Disease — SISREMCAD  

Idiopathic Multicentric Castleman's Disease Clinical Trial

Official title: A Phase 2 Study of Intrapatient Siltuximab Dose Escalation in Patients With Idiopathic Multicentric Castleman Disease That Has Progressed After Prior Siltuximab Treatment

Status Terminated

Clinical Trial Summary

Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD

Clinical Trial Description

This is an open-label, two-stage, Phase 2 study to investigate the safety, tolerability, and efficacy of administering increased siltuximab doses to patients with iMCD who progressed with elevated and rising serum C reactive protein (CRP) levels after prior treatment with siltuximab 11 mg/kg every 3 weeks (q3w) without unacceptable toxicity, and is primarily designed to leverage opportunities for intrapatient dose escalation with available clinical, nonclinical, and PK justification as a means to restore or enable disease control.

Enrolling in Stage 1a and Stage 1b of this study in parallel will be up to 6 patients each with siltuximab-relapsed or refractory IL-6-driven iMCD and TAFRO-iMCD patients, respectively, who will undergo intrapatient dose escalation of siltuximab beginning with 22 mg/kg q3w, then possibly dose escalating to 33 mg/kg q3w then 44 mg/kg q3w if clinically indicated in the absence of DLT. The justifications for escalating siltuximab doses up to 44 mg/kg q3w will be based on intrapatient dose escalation and DLT assessments as described below. ;

Related Conditions & MeSH terms

• Castleman Disease
• Idiopathic Multicentric Castleman's Disease

• NCT number: NCT04838860
• Study type: Interventional
• Source: EusaPharma (UK) Limited
• Status: Terminated
• Phase: Phase 2
• Start date: March 31, 2021
• Completion date: April 1, 2021