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

NCT07484113 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB-83208NCI-2026-03510
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

cGVHD

Outcome Measures

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.

  From first dose through 6 months after treatment initiation

Secondary Outcomes (5)

• Maximum Plasma Concentration (Cmax) of Sarilumab

  Baseline through 6 months

• Time to Maximum Plasma Concentration (Tmax) of Sarilumab

  Baseline through 6 months

• Area Under the Plasma Concentration-Time Curve (AUC) of Sarilumab

  Baseline through 6 months

• Incidence of serious infections

  From first dose through 6 months

• Overall response rate

  Up to 6 months

Study Arms (2)

Dose Level 1: Sarilumab 150 mg + Belumosudil

EXPERIMENTAL

Participants receive Belumosudil 200 mg orally once daily and sarilumab 150 mg subcutaneously every 2 weeks.

Drug: Belumosudil; Drug: Sarilumab

Dose Level 2: Sarilumab 200 mg + Belumosudil

EXPERIMENTAL

Participants receive Belumosudil 200 mg orally once daily and sarilumab 200 mg subcutaneously every 2 weeks.

Drug: Belumosudil; Drug: Sarilumab

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.

Dose Level 1: Sarilumab 150 mg + Belumosudil; Dose Level 2: Sarilumab 200 mg + Belumosudil

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

Dose Level 1: Sarilumab 150 mg + Belumosudil; Dose Level 2: Sarilumab 200 mg + Belumosudil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Laboratory Parameters:
• Absolute neutrophil count ≥ 1.5 x 109/L
• Platelet count ≥ 50 x 109/L
• ALT and AST \< 1.5 × ULN
• Total bilirubin ≤ 1.5 × ULN
• Glomerular filtration rate (GFR) ≥ 30 ml/min/1.73m2
• General Criteria:
• Negative urine pregnancy test at screening for females of childbearing potential.
• Sexually active females of childbearing potential must agree to use two accepted methods of contraception during treatment and for 3 months after their last dose.
• Sexually active male subjects with female partners of childbearing potential must agree to use two accepted methods of contraception and refrain from sperm donation during treatment and for at least 3 months after their last dose.
• \. Ability to provide written informed consent (or consent from legally authorized representative). 15. Minimum weight of 63 kg

You may not qualify if:

• 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.
• General Criteria:
• Pregnant or breastfeeding.
• History or other evidence of severe illness or any other conditions that would make the subject, in the opinion of the sponsor-investigator, unsuitable for the study (such as malabsorption syndromes, poorly controlled psychiatric disease or coronary artery disease).
• Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) or history of human immunodeficiency virus (HIV).
• Malignancy diagnosed within 3 years (other than malignancy for which transplant was performed), with the exception of:
• Completely resected basal cell or squamous cell carcinoma of the skin
• Carcinoma in situ of the cervix
• Resected breast ductal carcinoma in situ
• Prostate cancer with Gleason score \<6 and stable PSA over 12 months
• QTc(F) \> 480 ms
• Sponsor-investigator deems subject unlikely to adhere to study procedures/treatment.
• Investigational agent, device, or procedure within 28 days of first dose (or 5 half-lives, whichever longer).

Sponsors & Collaborators

• Stanford University: lead

MeSH Terms

Interventions

belumosudil; sarilumab

Study Officials

• Sally Arai, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally Arai, MD

CONTACT

(650) 725-6186; sarai1@stanford.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: March 19, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06