Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
NCT ID:
NCT06343792
Eligibility Criteria:
Inclusion Criteria:
* Male or female adults or adolescents (\>12 years old).
* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT
* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.
* No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.
* Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \>500/mL for at least 3 consecutive measurements and not supported by growth factor supplementation
* Weight ≥40 kg and ≤ 140 kg at screening.
Exclusion Criteria:
* Has received more than 1 allo-HSCT
* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD
* Previous failure of ruxolitinib treatment
* Uncontrolled GI infection
* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD
* Chronic GvHD
* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.
* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT
* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \>1 mg/kg per day within 7 days of enrollment.
* Severe organ dysfunction unrelated to underlying aGvHD
* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)
* Significant liver disease that is unrelated to GvHD
* Severe kidney disease
* Currently breast feeding.
* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.
* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.
* Active sepsis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06343792
Study Brief:
Protocol Section:
NCT06343792