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

January 13, 2023 updated by: Eledon Pharmaceuticals

AT-1501-I206: An Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Transplanted Islet Cells and AT-1501 Immunomodulation in Adults With Brittle Type 1 Diabetes

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the safety, tolerability and efficacy of transplantation of experimental islet cells as a potential treatment for brittle type 1 diabetes mellitus. It will also assess the safety, tolerability and efficacy of AT-1501 in an immunomodulation regimen in adult patients with brittle T1D undergoing an islet cell transplant. This is a single arm open-label study and up to 6 participants will be recruited at a single center in the United States.

The objectives include:

  • To assess the safety and tolerability of transplanted islet cells and immunomodulation with AT-1501, in combination (AT+) with rabbit anti-thymoglobulin (ATG), etanercept and mycophenolate mofetil (MMF/EC-MPS) in adults with T1D undergoing islet cell transplant.
  • To assess the efficacy of transplanted islet cells and immunomodulation with AT-1501 in adults with brittle T1D undergoing islet cell transplant.

The duration of treatment may vary from participant to participant and could be up to 2 years. Participants may receive up to 2 islet cell transplants.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18-65 years of age
  • A diagnosis of T1D ≥5 years with onset of disease at <40 years of age
  • Involvement in appropriate diabetes management in accordance with the standard of care, as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to Screening; using an insulin pump or multiple daily injection (MDI) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of unexplained SHEs
  • At least 3 unexplained SHEs not secondary to a missed meal or dosing error, in the 12 months prior to Screening
  • Glycosylated hemoglobin (HbA1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive
  • Absence of stimulated C peptide (< 0.3 ng/mL) in response to a mixed meal tolerance test (MMTT) measured at 60 and 90 minutes after the start of consumption
  • Impaired awareness of hypoglycemia (IAH) as defined by a Clarke Score [Clarke 1995] of 4 or more at the time of Screening, during the Screening period, and within the last 6 months prior to the transplant

Exclusion Criteria:

  • Any previous solid organ or islet allotransplant
  • Body mass index (BMI) >30 kg/m2
  • Insulin requirement >1.0 unit/kg/day or <15 units/day

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm AT-1501
Single-arm, open-label trial
Biological: AT-1501 IV Infusion
Investigational study drug
Biological: Isolated cadaveric islet cells
Infusion of human cadaveric islet cells into the portal vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)
Time Frame: Accessed from date of transplant through Day 364 post final transplant for approximately 2 years
Incidence of adverse events
Accessed from date of transplant through Day 364 post final transplant for approximately 2 years
Efficacy - Insulin independence
Time Frame: Date of transplant through Day 364 post- final transplant
The proportion of participants that become insulin independent at Days 75 and 365 post-first, and final transplant
Date of transplant through Day 364 post- final transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - HbA1c
Time Frame: Date of transplant through Day 364 post-final transplant
Proportion of participants with HbA1c <7.0% (53 mmol/mol) and free of serious hypoglycemic events (SHEs) from Day 28 to Day 364 post first and final transplant.
Date of transplant through Day 364 post-final transplant
Efficacy - Graft failure
Time Frame: Proportion of participants with graft failure at Day 364 post final transplant
Date of transplant through Day 364 post final transplant
Proportion of participants with graft failure at Day 364 post final transplant
Efficacy - Durability of insulin independence
Time Frame: Date of transplant through Day 364 post final transplant
The proportion of participants that become insulin independent at Day 364 post-transplant
Date of transplant through Day 364 post final transplant
Efficacy - Durability of insulin independence - long term
Time Frame: 2 and 3 years after discontinuation of AT- 1501
The proportion of participants that become insulin independent at year 2 and year 3
2 and 3 years after discontinuation of AT- 1501

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eledon Pharmaceuticals

Investigators

  • Study Director: Jeff Bornstein, MD, Eledon Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2028

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-1501-I206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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