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Posoleucel

Phase 2

Adenovirus Infection | Monoclonal antibody | Infectious Disease |Kalaris Therapeutics, Inc.|Last Updated: May 9, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04693637Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell TransplantPHASE2 COMPLETED 26Jan 15, 2021Jan 19, 2023May 9, 202416 United States
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Study Endpoints
Primary Endpoints
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Through Week 14

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

Secondary Endpoints
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)
Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV
Through Week 26
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Posoleucel (ALVR105)EXPERIMENTALAdministered as 2-4 milliliter infusion
Interventions
NameTypeDescription
Posoleucel (ALVR105)BIOLOGICALAdministered as 2-4 milliliter infusion
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Eligibility Criteria
Age Range1 Year — N/A
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria * ≥1 year of age at the day of screening visit. * Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening * Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clin...

Countries:United States
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