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

Part of paid clinical trials in Duarte, California.

Sponsor
ReAlta Life Sciences, Inc.
Study ID
NCT06343792
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Steroid Refractory GVHD

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 31, 2024
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: RLS-0071Cohort 1
    10 mg/kg Q8H RLS-0071 for 7 days
  • Experimental: RLS-0071 Cohort 2
    10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
  • Experimental: RLS-0071 Cohort 3
    20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
  • Experimental: RLS-0071 Cohort 4
    10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
  • Experimental: RLS-0071 Cohort 5
    20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
  • Experimental: RLS-0071 Expansion Cohort 1
    12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
  • Experimental: RLS-0071 Expansion Cohort 2
    12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days

Primary Outcome Measure

Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ Time Frame: Day 1 to Day 180 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Site 1091DuarteCalifornia91010-
Site 1343Los AngelesCalifornia90095-
Site 1318AtlantaGeorgia30041-
Site 1068St LouisMissouri63110-
Site 1100CincinnatiOhio45229-
Site 1382ColumbusOhio43210-

Find similar trials in Duarte, CA

By research site
Site 1091· Duarte, CASite 1343· Los Angeles, CASite 1318· Atlanta, GASite 1068· St Louis, MOSite 1100· Cincinnati, OHSite 1382· Columbus, OH