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

Launched by AVOTRES INC. · Mar 28, 2019

Keywords

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Gender

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Eligibility 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 16 or older and able to provide informed consent/assent.
• • 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/assent.
• 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, or \> 3.0 mg / dL for participants with Gilbert's Syndrome
• • 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.