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

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ClinicalTrials.gov Identifier: NCT03895996
Recruitment Status : Not yet recruiting
First Posted : March 29, 2019
Last Update Posted : April 16, 2019
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
Estimated Study Start Date : June 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 the past 12 months but at least 1 month prior to screening, 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, she must be willing to avoid pregnancy and have a negative pregnancy test through the duration of the trial.
  4. Signed and dated written informed consent.

Key Exclusion Criteria:

  1. Subjects on existing treatment with poorly controlled glycemic control 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, 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 non-T1D autoimmune conditions (except autoimmune thyroid and/or celiac diseases)
  15. Women who are pregnant, 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 baseline 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 Not yet 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     History of Changes
Other Study ID Numbers: AVT001-T1D-01
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
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