NCT06343792招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 10
- 主要终点
- Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •Active sepsis
研究组 & 干预措施
RLS-0071Cohort 1
Experimental
10 mg/kg Q8H RLS-0071 for 7 days
干预措施: RLS-0071 (Drug)
RLS-0071 Cohort 2
Experimental
10 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
干预措施: RLS-0071 (Drug)
RLS-0071 Cohort 3
Experimental
20 mg/kg Q8H RLS-0071 for 14 days with concurrent ruxolitinib
干预措施: RLS-0071 (Drug)
RLS-0071 Cohort 4
Experimental
10 mg/kg Q8H RLS-0071 for 7 days and then 10 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
干预措施: RLS-0071 (Drug)
RLS-0071 Cohort 5
Experimental
20 mg/kg Q8H RLS-0071 for 7 days and then 20 mg/kg QD RLS-0071 for 7 days with concurrent ruxolitinib
干预措施: RLS-0071 (Drug)
RLS-0071 Expansion Cohort 1
Experimental
12 participants will receive 10 mg/kg Q8H RLS-0071 for 14 days
干预措施: RLS-0071 (Drug)
RLS-0071 Expansion Cohort 2
Experimental
12 participants will receive 20 mg/kg Q8H RLS-0071 for 14 days
干预措施: RLS-0071 (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
时间窗: Day 1 to Day 180
Overall Response Rate (ORR) of RLS-0071
时间窗: Day 1 to Day 28
次要结局
- Non-relapse mortality(Day 1 - Day 180)
- Duration of hospital stay(Day 1 - Day 180)
- Attainment of Stage 0 or 1 lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD(Days 7, 14, 28, 56, and 180)
- Overall survival(Day 1 - Day 180)
- Change or shift in overall Grade of aGvHD(Day 0 - Days 7, 14, 28, 56, and 180.)
- Incidence of refractoriness (to RLS-0071 +/- ruxolitinib)(Days 7, 14, 28, 56, and 180)
- Overall corticosteroid use(Days 7, 14, 28, 56, and 180)
- Initiation of additional or alternative treatment(s) for aGvHD (including an increase in steroid dose to >2 mg/kg methylprednisolone equivalent)(Day 1 - Day 180)
- Change or shift in Stage for lower GI aGvHD, liver aGvHD, skin aGvHD, or upper GI aGvHD from baseline based on MAGIC Criteria(Days 7, 14, 28, 56, and 180)
研究者
研究点 (10)
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相关资讯
ReAlta Life Sciences Receives European Orphan Drug Designation for Graft-versus-Host Disease Treatment- ReAlta Life Sciences received European Medicines Agency Orphan Drug Designation for RLS-0071 (pegtarazimod) to treat Graft-versus-Host Disease, marking a significant regulatory milestone.
- The designation was supported by preliminary data from the company's ongoing Phase 2 trial in steroid-refractory acute GvHD patients across the US, Germany, and Spain.
- Pegtarazimod uniquely targets both neutrophil and complement-mediated inflammation pathways, addressing the specific mechanisms driving tissue damage in lower gastrointestinal aGvHD.
- The EMA designation provides regulatory benefits including reduced fees, clinical protocol assistance, and up to 10 years of market exclusivity if approved.last yearReAlta Life Sciences Doses First Patient in Phase 2 aGvHD Trial with RLS-0071- ReAlta Life Sciences has initiated a Phase 2 clinical trial of RLS-0071 for steroid-refractory acute graft-versus-host disease (aGvHD).
- The open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of RLS-0071 in hospitalized patients.
- RLS-0071, an investigational EPICC peptide, modulates both complement and innate inflammatory pathways, offering a novel dual-targeting mechanism.
- The FDA has granted Orphan Drug and Fast Track designations to RLS-0071 for the treatment of steroid-refractory aGvHD, highlighting its potential.last year