Trials Sponsors Conditions Drugs Pricing

Conditions

Acute graft versus host disease (aGvHD)

Outcome Measures

Primary Outcomes (2)

Safety and tolerability of RLS-0071 in the treatment of aGvHD.
ORR of RLS-0071 at 28 days (note that addition of any acute GvHD therapy, including an increase in steroid dose >2 mg/kg MPE, will be considered a treatment failure).

Secondary Outcomes (18)

CR at 7, 14, 28, 56, and 180 days.
VGPR Rate at 7, 14, 28, 56, and 180 days.
PR Rate at 7, 14, 28, 56, and 180 days.
ORR at 7, 14, 56, and 180 days.
ORR focused on lower GI response criteria only at 7, 14, 28, 56, and 180 days (for the overall study population and for the subset with lower GI aGvHD).
+13 more secondary outcomes

Interventions

IALILEPICCQERAA peptide sequence with a monodisperse polyethylene glycol tailType not reported

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17), Older Adult (65+)

You may qualify if:

Male or female adults or adolescents (>12 years old).
Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible. Any conditioning regimen and any anti-GVHD prophylactic program are permitted.

Sponsors & Collaborators

Realta Life Sciences Inc.
Industrylead

Study Sites (10)

Hospital Universitario Marques De Valdecilla

Santander, 39008, Spain

Aranzazu Bermudez942315321 maranzazu.bermudez@scsalud.es

University Hospital Virgen Del Rocio S.L.

Sevilla, 41013, Spain

José Antonio Pérez Simón+34671599150 josea.perez.simon.sspa@juntadeandalucia.es

Hospital Universitario De Salamanca

Salamanca, 37007, Spain

Lucía López Corral

Central Study Contacts

Katy Burdett

7579010452 KBurdett@realtals.com

Study Design

Study Type: interventional
Phase: phase 2

Study Record Dates

First Submitted

August 9, 2024

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2024-510582-42-02
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 04:35:13 UTC

Documents

K1_RLS_0071-203_EU_Recruitment and Informed Consent procedure

You may not qualify if:

Has received more than 1 allo-HSCT.
Current, previous, or planned (in the initial 7 days) use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib (unless initiated within 48 hours of enrollment per Section 6.1) for aGvHD (previously initiated aGvHD prophylaxis is permitted to continue).
Previous failure of ruxolitinib treatment.
Uncontrolled GI infection (e.g., CMV, Cdiff); note that participants with controlled GI infections can be enrolled as long as appropriate anti-infective treatment is initiated and administered.
Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD in those who are clinically suspected of having lower GI aGvHD; those participants should not be enrolled or should be discontinued from the study (and will be replaced) unless they otherwise meet the study entry criteria for skin, liver, and/or upper GI aGvHD.
Chronic GvHD (including presence of GVHD overlap syndrome as per National Institutes of Health [NIH] guidelines).
RLS0071 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, which in the opinion of the Investigator would pose a safety risk for participation in this trial.
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, including: a) Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GvHD and ongoing organ dysfunction) b) Clinically significant or uncontrolled cardiac disease including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, New York Heart Association Class III or IV congestive heart failure, circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy. c) Clinically significant respiratory disease that requires mechanical ventilation support or oxygen supplementation.
Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG) or PEG containing material.
Significant liver disease that is unrelated to GvHD
Severe kidney disease, with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 (chronic kidney disease [CKD] Stages 4-5).
Participation in any clinical research study evaluating an investigational product (IP) or therapy for GvHD prophylaxis or treatment within 1 month and less than 5 half-lives of IP prior to the Screening visit.
Currently breast feeding.
+5 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (18)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (10)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations