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HSC835

Phase 2

Single Umbilical Cord Blood Transplantation | Small molecule | Oncology |Novartis AG|Last Updated: Jan 5, 2021

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 Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01930162Safety and Tolerability of HSC835 in Patients With Hematological Malignancies Undergoing Single Umbilical Cord Blood TransplantPHASE2 COMPLETED 9Oct 7, 2014Aug 29, 2016Jan 5, 20211 United States
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Study Endpoints
Primary Endpoints
Absence of Graft Failure at Day 42
42 days

This endpoint was to study safety and tolerability of HSC835 as measured by the absence of graft failure at day 42 in excess of that currently observed with double umbilical cord blood (UCB) transplantation (DUCBT) with non-myeloablative (NMA) conditioning.

Secondary Endpoints
Incidence of Neutrophil Recovery Within 42 Days
42 days
Incidence of Non-relapse Mortality (NRM) Within 100 Days and One Year
1 year
Incidence of Overall Survival Within One Year
1 year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
HSC835EXPERIMENTALPatients with hematologic malignancies requiring UCB transplant with a NMA conditioning regimen.
Interventions
NameTypeDescription
HSC835DRUGHSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with a diagnosis that qualifies them for UCBT * Adequate organ function * Availability of eligible donor material Exclusion Criteria: * Pregnancy or breastfeeding women and women of child-bearing potential unless two acceptable forms of contraception are being used ...

Countries:United States
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