IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD
Starting soon · Phase 1
Conditions studied: cGVHD
In brief
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 facts
- Study ID
- NCT07484113
- Run by
- Stanford University
- People needed
- 10
- Starts
- 2026-07-01
- Expected to finish
- 2028-05-01
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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).
- Active TB or a history of incompletely treated TB regardless of screening Quantiferon Result.
Full record on ClinicalTrials.gov
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