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AVT001 for Type 1 Diabetes
Phase 1 & 2
Waitlist Available
Led By Jason Gaglia, MD
Research Sponsored by Avotres Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months post first dose
Summary
This trial is testing a new treatment called AVT001 for people who have just been diagnosed with type 1 diabetes. The goal is to see if AVT001 is safe and if it can help manage the disease by protecting or improving the function of insulin-producing cells in the pancreas.
Eligible Conditions
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 months post first dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months post first dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes from baseline of clinical parameters on CBC/differential, chemistry panel
The incidence and severity of local i.v.-site reactions
The incidence of treatment-emergent adverse events
Secondary study objectives
Assessment of the HLA-E-restricted CD8+ T cell regulatory activity ("potency assay")
Changes from baseline in HbA1c
Changes from baseline in the area under the curve (AUC) of the stimulated C-peptide levels over a 4-hour mixed meal tolerance test (MMTT)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AVT001 (Treatment)Experimental Treatment1 Intervention
Infusion of AVT001 (treatment)
Group II: Matched placeboPlacebo Group1 Intervention
Infusion of AVT001-matched placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AVT001
2019
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Avotres Inc.Lead Sponsor
Jason Gaglia, MDPrincipal InvestigatorJoslin Diabetes Center, Harvard Medical School
1 Previous Clinical Trials
65 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- It seems that the criterion "Zinc transporter 8 (ZnT8)" is incomplete. Can you provide more context or details about this criterion?Criterion: The presence of insulinoma-associated protein 2 (IA-2, also known as ICA-512).You are female, aged 18 years or older, and have reproductive potential.You have a medical condition that might need treatment to weaken or change your immune system.You have autoimmune conditions other than certain specific ones that are under control or being treated.You have signs of having hepatitis C.You have a positive test for hepatitis B indicating an active infection.You don't have suitable veins for a specific type of blood procedure called leukapheresis.You have received radiation therapy, immunotherapy, or chemotherapy in the past year.Your diabetes is not well controlled even with insulin, and the doctor doesn't think you should be in the study.Your blood levels of hemoglobin, white blood cells, neutrophils, lymphocytes, and platelets are too low.Your urine test shows more than 300 milligrams of albumin per gram of creatinine.Your kidney function is below a certain level, as measured by a blood test.Your liver test results show high levels of ALT or AST.Your bilirubin level is higher than 2.0 mg/dL, or higher than 3.0 mg/dL if you have Gilbert's Syndrome.You are currently taking strong medicines that weaken your immune system, except for certain types of steroid creams and inhaled steroids.You have a medical condition that is likely to limit your life expectancy to less than 5 years.This criterion refers to the presence of antibodies against glutamic acid decarboxylase, which is an enzyme found in the pancreas. If a person's body has these antibodies, it may indicate an autoimmune response that could affect their eligibility for the clinical trial.You have been diagnosed with type 1 diabetes within the last year and have specific antibodies in your blood.You currently have a positive test for HIV-1 or HIV-2.Your screening heart test shows a risky abnormality, according to the doctor or researchers.
Research Study Groups:
This trial has the following groups:- Group 1: AVT001 (Treatment)
- Group 2: Matched placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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