IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD

Sponsor
Stanford University
Study ID
NCT07484113
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belumosudil — DRUG
    Belumosudil (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 — DRUG
    Sarilumab 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

Study Details

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).

Key Dates

Start date
May 31, 2026
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Dose Level 1: Sarilumab 150 mg + Belumosudil
    Participants receive Belumosudil 200 mg orally once daily and sarilumab 150 mg subcutaneously every 2 weeks.
  • Experimental: Dose Level 2: Sarilumab 200 mg + Belumosudil
    Participants receive Belumosudil 200 mg orally once daily and sarilumab 200 mg subcutaneously every 2 weeks.

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: From first dose through 6 months after treatment initiation ]

Central Contacts

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