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Safety, Tolerability, and Efficacy of Immunomodulation With AT-1501 in Combination With Transplanted Islet Cells in Adults With Brittle T1D

NCT05480657 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-01-18

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with T1D undergoing an islet cell transplant.

Conditions

  • Brittle Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

AT-1501 IV Infusion

Investigational study drug

BIOLOGICAL

Isolated cadaveric islet cells

Infusion of human cadaveric islet cells into the portal vein

Sponsors & Collaborators

  • Eledon Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Jeff Bornstein, MD · Eledon Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2024-08-31
Completion
2028-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480657 on ClinicalTrials.gov