cGVHDPhase 1NCT07484113
IL6-receptor Inhibitor Iwith Belumosudil for the Treatment of Belumosudil-refractory cGVHD
A Phase 1 study testing Belumosudil and Sarilumab in people with cGVHD, run by Stanford University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- cGVHD
- What is being tested?
- Belumosudil and Sarilumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
- 14. Ability to provide written informed consent (or consent from legally authorized representative). 15. Minimum weight of 63 kg
Who cannot join
- 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).
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: IL6-receptor Inhibitor in Combination With Belumosudil for the Treatment of Belumosudil-refractory Chronic Graft-versus-host Disease (cGVHD)
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
- Being tested
- Belumosudil, Sarilumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
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.
SarilumabDrug
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 group | Role | What they receive |
|---|---|---|
| Dose Level 1: Sarilumab 150 mg + Belumosudil | Experimental | Participants receive Belumosudil 200 mg orally once daily and sarilumab 150 mg subcutaneously every 2 weeks. Receives: 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. Receives: Drug: Belumosudil; Drug: Sarilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first dose through 6 months after treatment initiation
Secondary outcomes (5)
Maximum Plasma Concentration (Cmax) of Sarilumab
Maximum observed plasma concentration of sarilumab following administration.
Measured: Baseline through 6 months
Time to Maximum Plasma Concentration (Tmax) of Sarilumab
Time required to reach maximum plasma concentration following sarilumab administration.
Measured: Baseline through 6 months
Area Under the Plasma Concentration-Time Curve (AUC) of Sarilumab
Area under the plasma concentration-time curve used to characterize sarilumab exposure.
Measured: Baseline through 6 months
Incidence of serious infections
To evaluate the incidence of serious infections associated with sarilumab monotherapy as a rescue in subjects with belumosudil refractory cGVHD.
Measured: From first dose through 6 months
Overall response rate
To evaluate preliminary efficacy of sarilumab monotherapy as a rescue in subjects with cGVHD after inadequate response to belumosudil
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Arai, MD, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484113
- Sponsor's protocol ID
- IRB-83208
- Other IDs
- NCI-2026-03510
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL6-receptor Inhibitor in Combination With Belumosudil for the Treatment of Belumosudil-refractory Chronic Graft-versus-host Disease (cGVHD)
- ClinicalTrials.gov ID
- NCT07484113
- Acronym / sponsor ID
- IRB-83208
- Conditions
- cGVHD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: Sarilumab 150 mg + Belumosudil | Experimental | Drug: Belumosudil, Drug: SarilumabParticipants receive Belumosudil 200 mg orally once daily and sarilumab 150 mg subcutaneously every 2 weeks. |
| Dose Level 2: Sarilumab 200 mg + Belumosudil | Experimental | Drug: Belumosudil, Drug: SarilumabParticipants receive Belumosudil 200 mg orally once daily and sarilumab 200 mg subcutaneously every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Absolute neutrophil count ≥ 1.5 x 109/L
Key exclusion criteria (16 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BelumosudilBelumosudil (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. | Drug | Dose Level 1: Sarilumab 150 mg + Belumosudil, Dose Level 2: Sarilumab 200 mg + Belumosudil |
| SarilumabSarilumab 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 | Drug | Dose Level 1: Sarilumab 150 mg + Belumosudil, Dose Level 2: Sarilumab 200 mg + Belumosudil |
Primary outcome
Incidence of treatment-emergent adverse events
Time frame: From first dose through 6 months after treatment initiation
To evaluate the safety and tolerability of sarilumab monotherapy for the treatment of cGVHD after inadequate response to Belumosudil.
5 secondary outcomes
Maximum Plasma Concentration (Cmax) of Sarilumab
Time frame: Baseline through 6 months
Time to Maximum Plasma Concentration (Tmax) of Sarilumab
Time frame: Baseline through 6 months
Area Under the Plasma Concentration-Time Curve (AUC) of Sarilumab
Time frame: Baseline through 6 months
Incidence of serious infections
Time frame: From first dose through 6 months
Overall response rate
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sally Arai, MD principal investigator
Stanford Universiy
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Belumosudil and Sarilumab in people with cGVHD, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sally Arai, MD ((650) 725-6186, sarai1@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (time frame: From first dose through 6 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.