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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 : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Avotres Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date May 9, 2019
Estimated Study Start Date  ICMJE June 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • The incidence of treatment-emergent adverse events [ Time Frame: 5 months post first dose ]
    Safety/tolerability outcomes
  • 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
  • The incidence and severity of local i.v.-site reactions, [ Time Frame: 5 months post first dose ]
    Safety/tolerability outcomes
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2019)
  • 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
  • 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
  • Changes from baseline in HbA1c [ Time Frame: 5 months post first dose ]
    Efficacy outcomes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Potential Efficacy of AVT001 in Patients With Type 1 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes Mellitus
Intervention  ICMJE
  • Drug: AVT001
    autologous dendritic cell therapy
  • Other: Placebo
    matched placebo
Study Arms  ICMJE
  • Experimental: AVT001 (Treatment)
    Infusion of AVT001 (treatment) in monthly doses x 3, 7x10^6-10x10^6 cells/dose
    Intervention: Drug: AVT001
  • Placebo Comparator: Matched placebo
    Infusion of AVT001-matched placebo in monthly doses x 3
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2019)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jason Gaglia, MD 888-813-8669 T1DTrials@joslin.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03895996
Other Study ID Numbers  ICMJE AVT001-T1D-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avotres Inc.
Study Sponsor  ICMJE Avotres Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Gaglia, MD Joslin Diabetes Center, Harvard Medical School
PRS Account Avotres Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP