Treatment for patients with steroid-refractory acute graft-versus-host disease
Phase 2 Open Label Prospective Dose-Ranging Clinical Trial With Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
This study is testing a new drug called RLS-0071 to see if it can help hospitalized patients with acute graft-versus-host disease who haven't improved with steroid treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | ReAlta Life Sciences, Inc. Industry-sponsored |
| Drugs / interventions | ruxolitinib |
| Locations | 11 sites (Duarte, California and 10 other locations) |
| Trial ID | NCT06343792 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, dosing, and efficacy of RLS-0071 in hospitalized patients suffering from steroid-refractory acute graft-versus-host disease (aGvHD). It is an open-label, prospective, dose-ranging escalation and expansion trial designed to assess the drug's effectiveness in patients who have not responded to standard steroid treatments. Participants must be hospitalized and meet specific criteria regarding their condition and treatment history. The trial aims to provide insights into the optimal dosing and potential benefits of RLS-0071 for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults or adolescents over 12 years old with steroid-refractory aGvHD after allo-HSCT.
Not a fit: Patients who have received more than one allo-HSCT or have uncontrolled gastrointestinal infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with steroid-refractory aGvHD, potentially improving their outcomes.
How similar studies have performed: While this approach is novel, similar studies targeting steroid-refractory aGvHD have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Duarte, California and 10 other locations
- Site 1091 — Duarte, California, United States (Active_not_recruiting)
- Site 1343 — Los Angeles, California, United States (Active_not_recruiting)
- Site 1318 — Atlanta, Georgia, United States (Active_not_recruiting)
- Site 1068 — St Louis, Missouri, United States (Active_not_recruiting)
- Site 1100 — Cincinnati, Ohio, United States (Active_not_recruiting)
- Site 1382 — Columbus, Ohio, United States (Active_not_recruiting)
- Site 3242 — Freiburg im Breisgau, Germany (Recruiting)
- Site 3101 — Seville, Se, Spain (Recruiting)
- Site 3360 — Madrid, Spain (Recruiting)
- Site 3227 — Salamanca, Spain (Recruiting)
- Site 3101 — Seville, Spain (Recruiting)
Study contacts
- Study coordinator: Linda Dell, MBA
- Email: ldell@realtals.com
- Phone: 201-675-4044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.