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Recruiting NCT06343792

Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease

Phase II Interventional Steroid Refractory GVHD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RLS-0071.
Who it may be relevant to
Registry conditions: Steroid Refractory GVHD. Basic parameters: from 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug RLS-0071
    RLS-0071 will be administered for 7 or 14 days according to the assigned dose group.

Primary outcome measures

  • Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [Time frame: Day 1 to Day 180]
  • Overall Response Rate (ORR) of RLS-0071 [Time frame: Day 1 to Day 28]
Secondary outcome measures (9)
  • Incidence of refractoriness (to RLS-0071 +/- ruxolitinib) [Time frame: Days 7, 14, 28, 56, and 180]
  • Overall corticosteroid use [Time frame: Days 7, 14, 28, 56, and 180]
  • Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent) [Time frame: Day 1 - Day 180]
  • Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria [Time frame: Days 7, 14, 28, 56, and 180]
  • Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD [Time frame: Days 7, 14, 28, 56, and 180]
  • Change or shift in overall Grade of aGvHD [Time frame: Day 0 - Days 7, 14, 28, 56, and 180.]
  • Overall survival [Time frame: Day 1 - Day 180]
  • Non-relapse mortality [Time frame: Day 1 - Day 180]
  • Duration of hospital stay [Time frame: Day 1 - Day 180]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • Site 1091 — Duarte
  • Site 1343 — Los Angeles
  • Site 1318 — Atlanta
  • Site 1068 — St Louis
  • Site 1100 — Cincinnati
  • Site 1382 — Columbus
Spain · 4 centers
  • Site 3101 — Seville
  • Site 3360 — Madrid
  • Site 3227 — Salamanca
  • Site 3101 — Seville
Germany · 1 center
  • Site 3242 — Freiburg im Breisgau

Identifiers

NCT: NCT06343792 · RLS-0071-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗