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Monoclonal Antibody

Stem Cell Mobilization + Immunotherapy for Type 1 Diabetes

Phase 1 & 2
Waitlist Available
Led By James Shapiro, MD, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is aged 18-45
One or more positive autoantibodies (GAD, ICA512, IA2A, ZnT8, mIAA) to confirm T1DM
Must not have
Baseline Hb < 105g/L in women, or < 120 g/L in men
Untreated proliferative retinopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, 6, 9, 12, 18 and 24
Awards & highlights
No Placebo-Only Group

Summary

This trial is based on the "immunological reset" approach to treat type 1 diabetes. T-depletion therapy and anti-inflammatory treatment will restore self-tolerance in T1DM patients. Autologous, peripheral-blood mobilized hematopoietic CD34+-enriched stem cells and a long-acting GLP-1 analogue will promote pancreatic islet regeneration and repair.

Who is the study for?
This trial is for adults aged 18-45 with recent-onset Type 1 Diabetes, confirmed by specific autoantibodies and some remaining insulin production. Participants must understand the study risks and consent to join. Exclusions include active infections, pregnancy or breastfeeding, substance abuse, certain psychiatric disorders, recent drug trials or surgeries, severe organ dysfunction, extreme anemia or uncontrolled diseases.
What is being tested?
The trial tests a combination of therapies in Type 1 Diabetes: T-cell depletion (Alemtuzumab), anti-inflammatory drugs (Anakinra and Etanercept), stem cell mobilization (Plerixafor) to regenerate pancreatic cells, and Liraglutide to promote repair. The goal is better preservation of insulin secretion without long-term immune suppression.
What are the potential side effects?
Potential side effects may include immune system reactions from Alemtuzumab leading to infusion-related symptoms; Anakinra and Etanercept might cause injection site reactions or increase infection risk; Plerixafor could result in gastrointestinal issues; Liraglutide may cause nausea or pancreatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old.
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I have tested positive for one or more autoantibodies confirming Type 1 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My hemoglobin level is below the normal range for my gender.
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I have an untreated eye condition where new blood vessels grow abnormally.
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I use more than 1 unit of insulin per kilogram of my body weight daily.
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I do not have severe heart problems like recent heart attacks or very weak heart pumping.
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I or my family have a history of MEN2 or medullary thyroid cancer.
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I am taking blood thinners other than aspirin, or my blood clotting time is longer than normal.
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I am suspected to have rapidly worsening kidney problems.
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I am on long-term steroids for another health issue.
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I have a history of cancer other than non-melanoma skin cancer.
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I do not have active infections like Hepatitis C, B, HIV, or tuberculosis.
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I have had Type 1 Diabetes for more than 6 months.
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I have Celiac disease that has not been treated.
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I am either younger than 18 or older than 45 years old.
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My cholesterol levels are very high and not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, 6, 9, 12, 18 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, 6, 9, 12, 18 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change of 2-hour mixed meal stimulated C-peptide AUC
Secondary study objectives
"Responder" status
Autoantibodies associated with T1DM
Exogenous insulin usage
+2 more

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT01395316
13%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alemtuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treated armExperimental Treatment5 Interventions
For participants assigned to the treated arm, they will follow study regime below: Intervention treatment will last from Day 0 up to Month 24. Day 0: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.). Day 1: Subjects will receive plerixafor (0.24 mg/kg/day) sc. to mobilize CD34+ stem cells to peripheral blood. Day 1: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 24 months.
Group II: Control armExperimental Treatment5 Interventions
For participant assigned to the control arm, they will be monitored and tested for the first 12 months, and receive intervention treatment from Month 12 up to Month 24. Month 12: Subjects will receive alemtuzumab (30mg iv single dose); anakinra (100 mg sc.); etanercept (50 mg sc.) and liraglutide (0.6 mg sc.). Month 12 + 1 day: Subjects will receive plerixafor (0.24 mg/kg/day) sc.. Month 12 + 1 day: Continuing with anakinra 100mg sc. daily for 12 month; etanercept 50mg sc. twice weekly for first 3 months, and 50mg sc. weekly for another 9 months; liraglutide 0.6 mg sc. daily for 7 days, then 1.2 mg sc. daily (or up to 1.8mg daily) as tolerated for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Plerixafor
2011
Completed Phase 3
~710
Alemtuzumab
2004
Completed Phase 4
~1880
Anakinra
2016
Completed Phase 4
~2240
Etanercept
2005
Completed Phase 4
~4720
Liraglutide
2013
Completed Phase 4
~2680

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
920 Previous Clinical Trials
431,742 Total Patients Enrolled
Alberta Innovates Health SolutionsOTHER
53 Previous Clinical Trials
94,121 Total Patients Enrolled
James Shapiro, MD, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
227 Total Patients Enrolled

Media Library

Alemtuzumab (Monoclonal Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT03182426 — Phase 1 & 2
Alemtuzumab (Monoclonal Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03182426 — Phase 1 & 2
~3 spots leftby Oct 2025
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