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Search / Trial NCT05565248

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

Launched by CRISPR THERAPEUTICS AG · Sep 30, 2022

Trial Information

Current as of June 05, 2025

Recruiting

Keywords

Type 1 Diabetes T1 D Allogeneic Combination Device Crispr Cas9 Cell Therapy T1 Dm Diabetes Vctx

ClinConnect Summary

This clinical trial is studying a new treatment called VCTX211, which is designed to help people with Type 1 Diabetes (T1D). The main goals of the study are to see how safe the treatment is, how well it works, and how well patients can tolerate it. The trial is currently recruiting participants and is open to anyone aged 18 and older who has been diagnosed with T1D for at least 5 years and has been on a stable diabetes treatment for the last 3 months.

To participate in the trial, individuals must not have had any organ transplants, must not have experienced severe low blood sugar episodes recently, and should not be on certain medications that weaken the immune system. If eligible, participants will have the chance to try this new treatment and will be closely monitored by medical professionals throughout the study. This trial is an important step in exploring new options for managing Type 1 Diabetes, and participants will be contributing to valuable research that could benefit others in the future.

Gender

ALL

Eligibility criteria

  • 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

About Crispr Therapeutics Ag

Crispr Therapeutics AG is a pioneering biotechnology company focused on developing transformative gene-based medicines using its proprietary CRISPR/Cas9 gene-editing technology. Founded in 2013 and headquartered in Zug, Switzerland, the company is dedicated to advancing the field of genetic medicine to address serious diseases, including genetic disorders, cancer, and autoimmune diseases. With a robust pipeline of clinical and preclinical programs, Crispr Therapeutics collaborates with leading institutions and industry partners to harness the potential of gene editing for innovative therapeutic solutions, aiming to improve patient outcomes and redefine the standards of care in modern medicine.

Locations

Edmonton, Alberta, Canada

Vancouver, British Columbia, Canada

Patients applied

0 patients applied

Trial Officials

Manasi Jaiman, MD, MPH

Study Director

ViaCyte

Sandeep Soni, MD

Study Director

CRISPR Therapeutics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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