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VCTX210A unit

Phase 1

Diabetes Mellitus | Small molecule | Immunology |CRISPR Therapeutics AG|Last Updated: Jun 26, 2023

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 Enrollment7
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05210530An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1DPHASE1 COMPLETED 7 — — Jan 24, 2022Jan 19, 2023Jun 26, 20233 Canada
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Study Endpoints
Primary Endpoints
Incidence of adverse events with causality related to VCTX210A units and/or the surgical procedures required to implant and explant the VCTX210A units.
From implantation up to 6 months post implantation
Secondary Endpoints
Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host innate immune cells within the graft.
From implantation up to 6 months post implantation
Qualitative evaluation of immune response to VCTX210A units assessed by histological staining for markers of host adaptive immune cells within the graft.
From implantation up to 6 months post implantation
Incidence of new alloreactive antibodies found in the blood of patients post implantation.
From implantation up to 6 months post implantation
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VCTX210A combination productEXPERIMENTALUp to seven (7) units will be implanted
Interventions
NameTypeDescription
VCTX210A unitCOMBINATION_PRODUCTCRISPR-Cas9 genetically modified PEC210A cells loaded into a delivery device
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria * Diagnosis of T1D for a minimum of 5 years * Stable, optimized diabetic regimen for at least 3 months prior to enrollment Exclusion Criteria * Medical history of islet cell, kidney, and/or pancreas transplant * Occurrence of 2 or more severe, unexplained hypoglycemic events wi...

Countries:Canada
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