Assessment of KAN-101 in Celiac Disease (ACeD)

Key Inclusion Criteria:

1. Adults aged 18 to 70 years inclusive

2. Diagnosed with celiac disease based on positive serology (eg, tissuetransglutaminase IgA antibody and/or deamidated gliadin peptide IgG) and intestinalhistology consistent with ≥ Marsh Type II or with evidence of villous atrophy

3. Has HLA-DQ2.5 genotype (HLA-DQA105 and HLA-DQB102) (homozygotes or heterozygotes)

4. Has followed a GFD for > 12 months immediately prior to study entry

5. Negative or weak positive for tTG-IgA and negative or weak positive for DGP-IgA/IgGduring screening

6. Male or female. Females of childbearing potential must use at least 2 acceptablebirth control methods

7. Capable of understanding and complying with protocol requirements

8. Patient understands and has signed the informed consent form

Key Exclusion Criteria:

1. Refractory celiac disease

2. Selective IgA deficiency

3. Positive for HLA-DQ8 (DQA103, DQB10302)

4. Previous treatment with tolerance-inducing therapies for celiac disease

5. Known wheat allergy

6. Part B only: History of hyperacute or prolonged symptoms following gluten exposure

7. Uncontrolled or significant medical conditions (including active infections orchronic hepatitis) which, in the opinion of the Investigator, preclude participation

8. History of dermatitis herpetiformis

9. Pregnant or breastfeeding