IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD
ConditioncGVHD
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
A single-center, Phase 1, open-label, investigator-initiated clinical trial evaluating the safety, tolerability, and preliminary efficacy of sarilumab (anti-IL-6R) monotherapy as a rescue in adult patients with belumosudil-refractory chronic graft-versus-host disease (cGVHD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Active cGVHD and currently receiving belumosudil with inadequate response (defined as disease progression at any time or failure to achieve at least a partial response after a minimum of 3 months of belumosudil therapy, and for whom the treating physician believes a new systemic therapy is required).
Persistent cGVHD manifestations and systemic therapy indicated.
Karnofsky Performance Score of ≥ 60.
Disqualifiers
Not on a stable systemic cGVHD treatments for at least 2 weeks prior to screening. (Note: Concomitant corticosteroids, calcineurin inhibitors, sirolimus are allowed. Systemic investigational GVHD treatments are not permitted).
Histological relapse of the underlying cancer or post-transplant lymphoproliferative disease at the time of screening.
Current treatment with ibrutinib or ruxolitinib. Prior treatment is allowed with a washout of at least 1 week prior to randomization.
Pregnant or breastfeeding.
Trial design
Design model
Sequential
Treatments tested in this trial
Belumosudil
DrugBelumosudil (2-(3-(4-(1H-indazol-5-ylamino) quinazolin-2-yl) phenoxy)-N-isopropylacetamide-methane sulfonic acid salt), formerly also known as KD025, is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor. Belumosudil will be provided as 200 mg tablets.
Sarilumab
DrugSarilumab is an interleukin-6 (IL-6) receptor antagonist FDA approved for treatment of: * Adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). * Adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. Sarilumab will be provided as single-use 1.14 ml prefilled glass syringes containing 131.6 mg/mL (150 mg), 175 mg/mL (200 mg) of sarilumab
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Dose Level 1: Sarilumab 150 mg + BelumosudilExperimental treatment 2 interventions
Group B: Dose Level 2: Sarilumab 200 mg + BelumosudilExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events
To evaluate the safety and tolerability of sarilumab monotherapy for the treatment of cGVHD after inadequate response to Belumosudil.
Time frame
From first dose through 6 months after treatment initiationSecondary outcomes
1
Maximum Plasma Concentration (Cmax) of Sarilumab
Maximum observed plasma concentration of sarilumab following administration.
Time frame
Baseline through 6 months2
Time to Maximum Plasma Concentration (Tmax) of Sarilumab
Time required to reach maximum plasma concentration following sarilumab administration.
Time frame
Baseline through 6 months3
Area Under the Plasma Concentration-Time Curve (AUC) of Sarilumab
Area under the plasma concentration-time curve used to characterize sarilumab exposure.
Time frame
Baseline through 6 months4
Incidence of serious infections
To evaluate the incidence of serious infections associated with sarilumab monotherapy as a rescue in subjects with belumosudil refractory cGVHD.
Time frame
From first dose through 6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: