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VCTX210A unit

Phase 1

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

Success Probability

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment7

FDA Designations

No designations recorded

Clinical trial landscape

VCTX210A unit · 1 trial · 7 indications

Phase 1 1
NCT05210530An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1DDiabetes Mellitus
COMPLETED7 Analytics
PHASE1COMPLETED
An Open-Label, FIH Study Evaluating the Safety and Tolerability of VCTX210A Combination Product in Subjects With T1D
Diabetes MellitusUnlock trial analytics

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 to 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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Frequently asked questions about VCTX210A unit

What is VCTX210A used for?

VCTX210A is an investigational combination product being studied for the treatment of type 1 diabetes mellitus. It is a small molecule therapy developed for patients with this condition, and it is currently in Phase 1 clinical development.

Who makes VCTX210A?

VCTX210A is being developed by CRISPR Therapeutics AG, a biopharmaceutical company traded on the stock exchange under the ticker symbol CRSP. The company is conducting clinical research on this investigational therapy for type 1 diabetes.

What phase is VCTX210A in?

VCTX210A is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. One Phase 1 clinical trial has been completed to evaluate its safety and tolerability in patients with type 1 diabetes.

What clinical trials is VCTX210A in?

VCTX210A has one completed clinical trial registered as NCT05210530. This was an open-label, first-in-human study evaluating the safety and tolerability of the VCTX210A combination product in subjects with type 1 diabetes. The trial enrolled 7 participants in Canada.

Is VCTX210A the same as any other drug?

VCTX210A is a unique investigational combination product developed by CRISPR Therapeutics AG. No alternative names for this therapy have been reported in clinical trial registrations. It is being studied specifically for type 1 diabetes mellitus.