Recruiting
Phase 2

RLS-0071

Sponsor:

ReAlta Life Sciences, Inc.

Code:

NCT06343792

Conditions

Steroid Refractory GVHD

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

RLS-0071

Study Details

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.

Conditions

Steroid Refractory GVHD

Study ID

NCT06343792

Start date

Aug 31, 2024

Status verified date

Aug, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

RLS-0071

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

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 ]
  • Overall Response Rate (ORR) of RLS-0071 [ Time Frame: Day 1 to Day 28 ]

Central Contacts and Locations

Central contacts

Linda Dell, MBA

201-675-4044ldell@realtals.com

Locations

Site 0191

Recruiting

Duarte, California, United States, 91010

Site 1343

Recruiting

Los Angeles, California, United States, 90095

Site 1318

Recruiting

Atlanta, Georgia, United States, 30041

Site 1068

Recruiting

St Louis, Missouri, United States, 63110

Site 1100

Recruiting

Cincinnati, Ohio, United States, 45229

Site 1382

Recruiting

Columbus, Ohio, United States, 43210

More Information

Sponsor

ReAlta Life Sciences, Inc.

Last update posted

Aug 26, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ReAlta Life Sciences, Inc. on 2025-08-26.