TerminatedPhase 1

An Open-Label, FIH Study Evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects With T1D

Stopped: Patients to be followed up in the VCTX-201 study

Canada5 participantsStarted 2023-01-20

Plain-language summary

This is an open-label, multicenter, Phase 1 study evaluating the Safety, Tolerability, and Efficacy of VCTX211 Combination Product in Subjects with T1D

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of T1D for a minimum of 5 years * Stable diabetes 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 within 6 months prior to enrollment * Known causes of diabetes other than T1D * Immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study * Prior treatment with gene therapy or edited product

What they're measuring

Incidence of adverse events with causality related to VCTX211 units, the surgical procedures and/or medical interventions required to implant and explant the VCTX211 units.

Timeframe: From implantation up to 12 months post implantation

Assess the clinical efficacy of VCTX211 units via evaluation of C-peptide increase from the baseline.

Timeframe: From implantation up to 12 months post implantation

Trial details

NCT IDNCT05565248

SponsorCRISPR Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-08

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