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

R

ReAlta Life Sciences

Status and phase

Enrolling
Phase 2

Conditions

Steroid Refractory GVHD

Treatments

Drug: RLS-0071

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06343792
RLS-0071-203

Details and patient eligibility

About

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.

Enrollment

66 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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
  • Moderate to 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

66 participants in 8 patient groups

RLS-0071Cohort 1
Experimental group
Description:
10 mg/kg Q8H RLS-0071 for 7 days
Treatment:
Drug: RLS-0071
RLS-0071 Cohort 2
Experimental group
Description:
40 mg/kg Q8H RLS-0071 for 7 days
Treatment:
Drug: RLS-0071
RLS-0071 Cohort 3
Experimental group
Description:
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Treatment:
Drug: RLS-0071
RLS-0071 Cohort 4
Experimental group
Description:
40 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
Treatment:
Drug: RLS-0071
RLS-0071 Cohort 5
Experimental group
Description:
10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Treatment:
Drug: RLS-0071
RLS-0071 Cohort 6
Experimental group
Description:
40 mg/kg Q8H RLS-0071 for 7 days and then 40 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
Treatment:
Drug: RLS-0071
RLS-0071 Expansion Cohort 1
Experimental group
Description:
12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days
Treatment:
Drug: RLS-0071
RLS-0071 Expansion Cohort 2
Experimental group
Description:
12 participants will receive 10 or 40 mg/kg Q8H RLS-0071 for 7 or 14 days
Treatment:
Drug: RLS-0071

Trial contacts and locations

3

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Central trial contact

Linda Dell, MBA

Data sourced from clinicaltrials.gov

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