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PLX-R18

Phase 1

Incomplete HCT (Hematopoietic Cell Transplantation) | Monoclonal antibody | Other |Pluri Inc.|Last Updated: Dec 16, 2022

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03002519Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell TransplantationPHASE1 COMPLETED 21 — — Feb 8, 2017Oct 30, 2021Dec 16, 202210 United States, Israel
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Study Endpoints
Primary Endpoints
Emergent Adverse Events (AEs)
Recorded after time of consent throughout the study until the last visit (~1 year)
Safety laboratory values (including immunological testing)
Blood samples will be collected on each visit, through study completion (~1 year)
Vital signs
Will be assessed during each visit, through study completion (~1 year)
ECG
Will be assessed during the screening visit, before each IP treatment visit and on the 14th day of participation (visit 5).
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PLX-R18EXPERIMENTALDose Escalation- first three subjects will be enrolled in the low dose cohort, 6 subjects in the intermediate-dose cohort, and 15 subjects in the high dose cohort.
Interventions
NameTypeDescription
PLX-R18BIOLOGICALIntramuscular (IM) administration of PLX-R18
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Age ≥18 years. 2. At least 3 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment. 3. Sustained platelet count ≤50,000/µL, and/or sustained Hb ≤8 g/dL and/or sustained ANC ≤1000/mm3, attr...

Countries:United StatesIsrael
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