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

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.