NCT06343792 Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease
| NCT ID | NCT06343792 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | ReAlta Life Sciences, Inc. |
| Condition | Steroid Refractory GVHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-08-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 66 participants in total. It began in 2024-08-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06343792 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Steroid Refractory GVHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06343792 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06343792 currently recruiting?
Yes, NCT06343792 is actively recruiting participants. Contact the research team at ldell@realtals.com for enrollment information.
Where is the NCT06343792 trial being conducted?
This trial is being conducted at Duarte, United States, Los Angeles, United States, Atlanta, United States, St Louis, United States and 7 additional locations.
Who is sponsoring the NCT06343792 clinical trial?
NCT06343792 is sponsored by ReAlta Life Sciences, Inc.. The trial plans to enroll 66 participants.