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Monoclonal Antibodies

Treatment for Diabetes

Q: Am I eligible to enroll in this clinical trial?

The trial is seeking 3 male or female participants aged between 18 and 65, diagnosed with T1D for at least 5 years starting before the age of 40. Participants must be capable of providing informed consent, adhere to study procedures including continuous glucose monitoring (CGM), have experienced a minimum of three unexplained severe hypoglycemic events (SHEs) without missed meals or dosing errors in the past year, show an HbA1c level ranging from 7.0% (48 mmol/mol) to 9.5% (80 mmol/mol), lack stimulated C-peptide

Q: Are there any available positions for participants in this research study?

The ongoing clinical trial, as detailed on clinicaltrials.gov, is actively seeking participants. Initially shared on March 4th, 2024, the study's most recent update was made on March 25th of the same year.

Q: What is the current number of participants being recruited for this research project?

Indeed, information available on clinicaltrials.gov confirms that this investigation is currently seeking suitable candidates. The trial was initially listed on March 4th, 2024, and its most recent update was on March 25th, 2024. This study aims to enroll three participants from one specific site.

Q: Could individuals younger than 55 years old participate in this medical study?

To qualify for enrollment in this research study, individuals must be between 18 and 65 years of age.

Phase 1 & 2

Recruiting

Led By John Fung, MD PhD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 365 and from day 28 through to day 365

Awards & highlights

Study Summary

"This trial is testing a drug called AT-1501, which is a man-made protein that works like the natural antibodies in our body. It is designed to help prevent the immune system from attacking trans

Who is the study for?

Adults aged 18-65 with brittle Type 1 Diabetes Mellitus, diagnosed for over 5 years and onset before age 40. Participants must have had at least three severe hypoglycemic episodes in the past year not due to missed meals or dosing errors, an HbA1c level between 7.0% and 9.5%, no C-peptide response after a meal test, impaired awareness of hypoglycemia, and be under regular diabetes management.Check my eligibility

What is being tested?

The trial is testing AT-1501, a man-made antibody designed to suppress the immune system without harming transplanted islet cells that produce insulin. This could help prevent the body from rejecting these cells in patients with T1D who receive cell transplants to manage their condition.See study design

What are the potential side effects?

As AT-1501 works by suppressing the immune system, potential side effects may include increased risk of infections, possible infusion reactions where the drug enters the body, allergic responses or autoimmunity issues where the body attacks its own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 365 and from day 28 through to day 365

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 365 and from day 28 through to day 365

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 365 and from day 28 through to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants who are insulin-independent post- first and final transplant

Secondary outcome measures

Number of Participants with glycosylated hemoglobin (HbA1c) <7.0%

Other outcome measures

Change in albumin excretion ratio (AER) post-first and final transplant.

Change in estimated glomerular filtration rate (eGFR) post-first and final transplant.

Change in glycemic lability after final islet cell transplant and years after discontinuation of AT-1501

+6 more

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cure AllianceUNKNOWN

Juvenile Diabetes Research FoundationOTHER

232 Previous Clinical Trials

141,781 Total Patients Enrolled

4 Trials studying Diabetes

611 Patients Enrolled for Diabetes

University of ChicagoLead Sponsor

1,004 Previous Clinical Trials

819,774 Total Patients Enrolled

12 Trials studying Diabetes

7,691 Patients Enrolled for Diabetes

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to enroll in this clinical trial?

"The trial is seeking 3 male or female participants aged between 18 and 65, diagnosed with T1D for at least 5 years starting before the age of 40. Participants must be capable of providing informed consent, adhere to study procedures including continuous glucose monitoring (CGM), have experienced a minimum of three unexplained severe hypoglycemic events (SHEs) without missed meals or dosing errors in the past year, show an HbA1c level ranging from 7.0% (48 mmol/mol) to 9.5% (80 mmol/mol), lack stimulated C-peptide"

Answered by AI

Are there any available positions for participants in this research study?

"The ongoing clinical trial, as detailed on clinicaltrials.gov, is actively seeking participants. Initially shared on March 4th, 2024, the study's most recent update was made on March 25th of the same year."

Answered by AI

What is the current number of participants being recruited for this research project?

"Indeed, information available on clinicaltrials.gov confirms that this investigation is currently seeking suitable candidates. The trial was initially listed on March 4th, 2024, and its most recent update was on March 25th, 2024. This study aims to enroll three participants from one specific site."

Answered by AI