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
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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

First listed
Apr 3, 2024
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