Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the Treatment of Patients With Virus-Associated Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplant

AlloVir, Inc.0 个研究点目标入组 125 人开始时间: 2021年10月29日最近更新: 2022年3月14日

试验速览

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•Participants must meet all of the following criteria in order to be eligible to participate in the study:
•1. Male or female but enrollment of participants <1 year of age at the time of informed consent will occur only once preliminary safety data are available from 5 participants =1 and =6 years of age.
•2. Had an allogeneic hematopoietic cell transplant (HCT) performed = 21 days and = 1 year prior to randomization.
•3. Myeloid engraftment confirmed.
•4. Diagnosed with Hemorrhagic Cystitis.
•5. At least 1 identified, suitably matched ALVR105 cell line for infusion is available.
•6. Willing and able to provide written informed consent to participate in the study, or a parent or legal guardian is willing and able to provide written informed consent and the potential pediatric patient is able to provide assent in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.
•7. Agree to use an effective contraceptive method during the study and for a minimum of 90 days after study treatment for all participants of childbearing potential.
•8. A negative serum pregnancy test for female participants of childbearing potential.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 35
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 18

•Participants who meet any of the following criteria will be excluded from participation in the study:
•1. Ongoing therapy with high-dose systemic corticosteroids.
•2. Therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other immunosuppressive T cell-targeted monoclonal antibodies < 28 days before randomization.
•3. Evidence of active Grade >2 acute GVHD.
•4. Uncontrolled or progressive bacterial or fungal infections.
•5. Uncontrolled or progressive viral infections not targeted by ALVR105.
•6. Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative disorder.
•7. Known or presumed pneumonia secondary to any organism.
•8. Donor lymphocyte infusion performed = 21 days prior to randomization.
•9. Hemodynamic or respiratory instability.
•10. Hemoglobin <7 g/dL despite red blood cell transfusions.
•11. Clinically significant coagulopathy.
•12. Ongoing use of systemic anticoagulant drugs or antiplatelet drugs.
•13. Evidence of active hepatic sinusoidal obstruction syndrome.
•14. Liver dysfunction.
•15. Renal dysfunction.
•16. Evidence of encephalopathy.
•17. Relapse of primary malignancy.
•18. Receipt of other investigational antiviral treatments (eg, brincidofovir) within 28 days prior to randomization.
•19. Pregnant, lactating, planning to become pregnant.
•20. History of severe allergy to any component of ALVR105.
•21. Any condition that would compromise the safety of the participant.

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