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

NCT05480657 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: AT-1501-I206
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AT-1501; Type 1 Diabetes; T1D; Islet Cell Transplant; humanized blocking antibody to CD40L; CD40L inhibitor; monoclonal antibody; Glucose Metabolism Diseases; Diabetes Mellitus; Type 1; Endocrine System Diseases; Graft; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Hypoglycemia; Hyperglycemia; Brittle T1D; Brittle Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Safety - Adverse Events (AE) and Adverse Events of Special Interest (AEoSI)

  Incidence of adverse events

  Accessed from date of transplant through Day 364 post final transplant for approximately 2 years

• Efficacy - Insulin independence

  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 Outcomes (4)

• Efficacy - HbA1c

  Date of transplant through Day 364 post-final transplant

• Efficacy - Graft failure

  Proportion of participants with graft failure at Day 364 post final transplant

• Efficacy - Durability of insulin independence

  Date of transplant through Day 364 post final transplant

• Efficacy - Durability of insulin independence - long term

  2 and 3 years after discontinuation of AT- 1501

Study Arms (1)

Single Arm AT-1501

EXPERIMENTAL

Single-arm, open-label trial

Biological: AT-1501 IV Infusion; Biological: Isolated cadaveric islet cells

Interventions

AT-1501 IV Infusion BIOLOGICAL

Investigational study drug

Single Arm AT-1501

Isolated cadaveric islet cells BIOLOGICAL

Infusion of human cadaveric islet cells into the portal vein

Single Arm AT-1501

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eledon Pharmaceuticals: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Endocrine System Diseases; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jeff Bornstein, MD

  Eledon Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label trial

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: September 30, 2022
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2028
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)