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Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03895996
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Avotres Inc.

Brief Summary:
This is a double-blind, randomized , placebo-controlled study to evaluate the safety and tolerability of AVT001, and to assess AVT001 as a potential treatment for type 1 diabetes (T1D). The trial will involve approximately 24 new-onset T1D subjects.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: AVT001 Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 / 2 Double-Blind, Randomized, Placebo Controlled Study of Safety, Tolerability and Potential Efficacy of AVOTRES Cell-Based Therapy (AVT001) in Patients With Type 1 Diabetes
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: AVT001 (Treatment)
Infusion of AVT001 (treatment) in monthly doses x 3, 7x10^6-10x10^6 cells/dose
Drug: AVT001
autologous dendritic cell therapy

Placebo Comparator: Matched placebo
Infusion of AVT001-matched placebo in monthly doses x 3
Other: Placebo
matched placebo




Primary Outcome Measures :
  1. The incidence of treatment-emergent adverse events [ Time Frame: 5 months post first dose ]
    Safety/tolerability outcomes

  2. Changes from baseline of clinical parameters on CBC/differential, chemistry panel [ Time Frame: 5 months post first dose ]
    Safety/tolerability outcomes - the clinical parameters tested include creatinine, AST, ALT, and total bilirubin

  3. The incidence and severity of local i.v.-site reactions, [ Time Frame: 5 months post first dose ]
    Safety/tolerability outcomes


Secondary Outcome Measures :
  1. Assessment of the HLA-E-restricted CD8+ T cell regulatory activity ("potency assay") [ Time Frame: 5 months post first dose ]
    Efficacy outcomes - "potency assay" measures the activity of CD8+ T regulatory cells

  2. 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) [ Time Frame: 5 months post first dose ]
    Efficacy outcomes

  3. Changes from baseline in HbA1c [ Time Frame: 5 months post first dose ]
    Efficacy outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Diagnosis of type 1 diabetes, within 12 months of first dosing, confirmed by positive lab result for one or more of the following types of autoantibodies:

    1. Glutamic acid decarboxylase (GAD65)
    2. Insulinoma associated protein 2 (IA-2, also known as ICA-512)
    3. Zinc transporter 8 (ZnT8).
  2. Age 18 or older and able to provide informed consent.
  3. If a participant is female with reproductive potential, willing to avoid pregnancy through the duration of the trial.
  4. Signed and dated written informed consent.

Key Exclusion Criteria:

  1. Poorly controlled diabetes despite insulin therapy, who in the opinion of the investigator would not be a good candidate for participation in a clinical trial
  2. Screening hemoglobin <10.0 g/dL; leukocytes <3,000/uL; neutrophils <1,500/uL; lymphocytes <800/uL; platelets <100,000/uL
  3. Screening Urine Albumin Excretion > 300mg/gmCr
  4. Screening eGFR < 60 mL/min/1.73m2
  5. Screening ALT or AST > 1.5x upper limit of normal (ULN)
  6. Screening bilirubin > 2.0 mg / dL
  7. Current use of immunosuppressive or immunomodulatory therapies, including pharmacologic doses of systemic steroids. However, topical steroidal creams and inhaled steroids without large systemic absorption are allowed.
  8. Coincident medical condition likely to require immunosuppressive or immunomodulatory therapies.
  9. Coincident medical condition likely to limit short term (5 year) life expectancy (malignancy, symptomatic coronary artery disease, recent stroke)
  10. Prior radiation therapy, immunotherapy (within 1 year of screening), or chemotherapy
  11. Serologic evidence of current HIV-1 or HIV-2 infection
  12. Serologic evidence of hepatitis C infection
  13. Serologic evidence of acute or chronic active hepatitis B as measured by Core Ab positive and / or Surface Antibody antigen positive
  14. Subjects with other autoimmune conditions (except compensated or treated autoimmune thyroid, celiac, alopecia, or vitiligo diseases)
  15. Women who are pregnant (pregnancy testing during screening), breastfeeding, or planning pregnancy during the study period
  16. Inadequate venous access to support leukapheresis
  17. Any condition that in the opinion of the investigator(s) would preclude the subject from participating in a clinical trial.
  18. Abnormal screening ECG that in the opinion of the investigator or sponsor would pose a safety risk.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895996


Contacts
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Contact: Jason Gaglia, MD 888-813-8669 T1DTrials@joslin.harvard.edu

Locations
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United States, Massachusetts
Joslin Diabetes Center, Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02215
Contact: Jason Gaglia, MD, MMSc         
Sponsors and Collaborators
Avotres Inc.
Investigators
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Principal Investigator: Jason Gaglia, MD Joslin Diabetes Center, Harvard Medical School

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Responsible Party: Avotres Inc.
ClinicalTrials.gov Identifier: NCT03895996    
Other Study ID Numbers: AVT001-T1D-01
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases