A Phase 1B Open-label/Phase 2 Double-blind Placebo- Controlled Study for Pharmacodynamic (PD) Activity, Pharmacokinetics (PK), Safety, and Tolerability of KAN-101 In Patients With Celiac Disease (CeD)
Phase: PHASE1
Conditions: Celiac Disease
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 1
Title Page
A PHASE 1B OPEN-LABEL/ PHASE 2 DOUBLE-BLIND PLACEBO-
CONTROLLED STUDY FOR PHARMACODYNAMIC ACTIVITY, 
PHARMACOKINETICS, SAFETY AND TOLERABILITY OF KAN-101 IN 
PATIENTS WITH CELIAC DISEASE
Study Intervention Number:
KAN-101
Study Intervention Name:
N/A
US IND Number:
19492
EudraCT/EU CT Number:
N/A
ClinicalTrials.gov ID:
NCT05574010
Pediatric Investigational Plan Number:
N/A
Protocol Number:
KAN-101-02
Phase:
Phase 1b/2
Brief Title:
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 
in People With Celiac Disease
This document and accompanying materials contain confidential information belonging to Kanyos Bio, 
Inc., a wholly owned subsidiary of Anokion SA as Sponsor, and Pfizer. Except as otherwise agreed to in 
writing, by accepting or reviewing these documents, you agree to hold this information in confidence and 
not copy or disclose it to others (except where required by applicable law) or use it for unauthorized 
purposes. In the event of any actual or suspected breach of this obligation, Kanyos Bio, Inc. and Pfizer 
must be promptly notified.
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 2
Document History
Document 
Version Date
Amendment 3
30 Jan 2024
Amendment 2
06 Nov 2023
Amendment 1
21 Jun 2023
Original protocol
31 Aug 2022
This amendment incorporates all revisions to date, including amendments made at the 
request of country health authorities and IRBs/ECs and any protocol administrative change 
letter(s).
Protocol Amendment Summary of Changes Table
Amendment 3 (30 January 2024)
Description of Change
Brief Rationale
Section # and Name 
Substantial Modification(s)
Modified Part B design as 
follows: 
(a) Updated number of 
participants enrolled in Part 
B to “approximately 16 
participants (4 participants 
per treatment group)” 
(b) Updated primary and 
secondary endpoint analysis 
and estimands by removing 
power calculations and 
adding “descriptive 
summaries will be reported” 
in relevant sections
After review of emerging 
safety data, the study design 
is modified to close Part B 
after 16 participants 
enrolled.
These changes were 
implemented to ensure 
greater participant safety, 
with the assumption that 
screening GC prior to 
dosing was leading to 
sensitization and thereby, 
higher number and severity 
of TEAEs observed in Part 
B compared to Part A, 
where participants were 
dosed without prior GC. 
Accordingly, primary 
endpoint analysis and 
estimands were updated.
All Sections
Section 1 Protocol Summary
Section 3 Objectives, 
Endpoints and Estimands
Section 4 Study Design
Section 5 Study Population
Section 6 Study 
Intervention(s) and 
Concomitant Therapy
Section 8 Study 
Assessments and Procedures
Section 9 Statistical 
Considerations
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 3
Description of Change
Brief Rationale
Section # and Name 
Added Part C to study 
design including relevant 
subsections
In Part C, screening GC is 
not present and additional  
assessments are added. 
All Sections
Section 1 Protocol Summary
Section 3 Objectives, 
Endpoints and Estimands
Section 4 Study Design
Section 5 Study Population
Section 6 Study 
Intervention(s) and 
Concomitant Therapy
Section 8 Study 
Assessments and Procedures
Section 9 Statistical 
Considerations
Added clarification that 
efficacy assessments are not 
performed, instead PD 
activity is being measured
The primary objective of the 
study is to evaluate PD 
activity.
Section 8.2 Efficacy 
Assessments
Section 8.4.8.1 Lack of 
Efficacy
Non-substantial modifications
Added “and Part C” (in 
addition to Part B) to the 
title, subtitle, text,  and notes 
wherever applicable
When Part C activities are 
similar to Part B and no 
additional description is 
needed, the sections are 
modified with adding “Part 
C” to relevant sections.  
All Sections
Section 1 Protocol Summary
Section 2 Introduction
Section 3 Objectives, 
Endpoints and Estimands
Section 4 Study Design
Section 6 Study Intervention
Section 8 Study 
Assessments and Procedures
Section 9 Statistical 
Considerations
Section 10 Supporting 
Documentation and 
Operational Considerations
Updated language to clarify 
screen failure
Updated for clarity.
Section 5.4 Screen Failures
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 4
Description of Change
Brief Rationale
Section # and Name 
Added blood volumes for 
Part C
In Part C, volume of blood 
collected is different than 
Part B.
Section 8.1 Administrative 
Procedures
Updated blood volumes for 
Parts A and B
Updated blood volumes 
according to the actual 
blood volume collected in 
Parts A and B.
Section 8.1 Administrative 
Procedures
Added “when collected, 
ECG values should be 
entered in clinical database” 
for ECG assessment
Updated for clarity.
Section 8.3.3
Electrocardiograms
Added hsCRP to clinical 
laboratory tests table
Added for a more 
comprehensive chemistry 
panel in Part C.
Section 10.2 Clinical 
Laboratory Tests
Moved the summary of 
changes for previous 
amendments to Appendix 12
Moved to align with the 
updates in protocol 
template.
Section 10.12 Appendix 12: 
Protocol Amendment 
History
Added updated language for 
emergency contact 
information
The process for contacting a 
medically qualified 
individual has changed from 
a medical escalation process 
via a Pfizer Call Center to 
direct clinical team contact 
using a study team contact 
list, thereby, replacing 
emergency contact card with 
study information card.
Section 10.1.11 Sponsor’s 
Medically Qualified 
Individual
Section 10.1.13 Appendix 
13: Abbreviations
Other editorial changes 
made for consistency and 
alignment
Editorial
Throughout the document
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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TABLE OF CONTENTS
LIST OF TABLES...................................................................................................................11
1. PROTOCOL SUMMARY...................................................................................................12
1.1. Synopsis ..................................................................................................................12
1.2. Schema ....................................................................................................................23
1.2.1. Part A Study Design Schema......................................................................23
1.2.2. Part B Study Design Schema......................................................................23
1.2.3. Part C Study Design Schema......................................................................24
1.3. Schedule of Activities .............................................................................................25
1.3.1. Part A (Phase 1b – Open-Label).................................................................25
1.3.2. Part B (Phase 2 – Double-Blind) ................................................................29
1.3.3. Part C (Phase 2 – Double-Blind) ................................................................33
2. INTRODUCTION ...............................................................................................................37
2.1. Study Rationale .......................................................................................................37
2.2. Background .............................................................................................................37
2.2.1. Celiac Disease.............................................................................................37
2.2.2. KAN-101 ....................................................................................................38
2.2.3. Clinical Overview.......................................................................................38
2.3. Benefit/Risk Assessment.........................................................................................39
2.3.1. Risk Assessment.........................................................................................40
2.3.2. Benefit Assessment.....................................................................................42
2.3.3. Overall Benefit/Risk Conclusion................................................................42
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS ...........................................................42
4. STUDY DESIGN.................................................................................................................44
4.1. Overall Design.........................................................................................................44
4.1.1. Part A: Phase 1b, Open-Label, Multiple Ascending Dose Study...............45
4.1.1.1. Part A Multiple Dose Escalation...............................................45
4.1.2. Part B: Phase 2, Double-Blind, Placebo-Controlled Study ........................47
4.1.3. Part C: Phase 2, Double-Blind, Placebo-Controlled Study ........................48
4.2. Scientific Rationale for Study Design.....................................................................49
4.2.1. Choice of Contraception/Barrier Requirements .........................................50
4.3. Justification for Dose ..............................................................................................51
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Final Protocol Amendment 3, 30 Jan 2024
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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4.3.1. Exposure Limits for Dose Escalation .........................................................51
4.3.2. Dose Justification for Part A and Part B and Part C...................................51
4.4. End of Study Definition ..........................................................................................52
5. STUDY POPULATION......................................................................................................52
5.1. Inclusion Criteria.....................................................................................................53
5.2. Exclusion Criteria....................................................................................................54
5.3. Lifestyle Considerations..........................................................................................57
5.3.1. Contraception..............................................................................................57
5.3.2. Meals and Dietary Restrictions...................................................................57
5.3.3. Caffeine, Alcohol, and Tobacco .................................................................57
5.3.4. Activity .......................................................................................................57
5.4. Screen Failures ........................................................................................................57
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY.................................58
6.1. Study Intervention(s) Administered........................................................................59
6.1.1. Administration............................................................................................60
6.2. Preparation, Handling, Storage, and Accountability...............................................60
6.2.1. Preparation and Dispensing........................................................................61
6.3. Assignment to Study Intervention...........................................................................62
6.4. Blinding...................................................................................................................62
6.4.1. Blinding of Participants..............................................................................62
6.4.2. Blinding of Site Personnel..........................................................................62
6.4.3. Blinding of the Sponsor..............................................................................62
6.4.4. Breaking the Blind......................................................................................63
6.5. Study Intervention Compliance...............................................................................63
6.6. Dose Modification...................................................................................................63
6.6.1. Dose Escalation Safety Review Period for Part A......................................63
6.6.1.1. Individual and Cohort Stopping Rules......................................64
6.7. Continued Access to Study Intervention After the End of the Study......................65
6.8. Treatment of Overdose............................................................................................65
6.9. Prior and Concomitant Therapy..............................................................................66
6.9.1. Prohibited During the Study.......................................................................66
6.9.2. Permitted During the Study ........................................................................66
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Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
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6.9.3. Rescue Medicine.........................................................................................67
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL...........................................................................67
7.1. Discontinuation of Study Intervention ....................................................................67
7.1.1. Liver Injury.................................................................................................68
7.1.2. Pregnancy ...................................................................................................68
7.1.3. COVID-19 ..................................................................................................68
7.1.4. Temporary Discontinuation........................................................................68
7.2. Participant Discontinuation/Withdrawal From the Study.......................................69
7.2.1. Withdrawal of Consent...............................................................................69
7.3. Lost to Follow-Up ...................................................................................................70
8. STUDY ASSESSMENTS AND PROCEDURES...............................................................70
8.1. Administrative Procedures ......................................................................................70
8.2. Efficacy Assessments..............................................................................................71
8.2.1. Gluten Challenge ........................................................................................71
8.2.1.1. Confirmation of Symptomatic Response to Run-in GC 
(Part B Only) .....................................................................................72
8.2.2. Plasma IL-2 Biomarker Assessment...........................................................72
8.2.3. Patient Reported Outcomes ........................................................................72
8.2.3.1. CDSD v2.1 ................................................................................72
8.2.3.2. PGIC..........................................................................................72
8.2.3.3. PGIS ..........................................................................................72
8.2.4. Esophagogastroduodenoscopy With Biopsy (Biopsy Substudy Only) ......72
8.2.4.1. Histological Assessments (Biopsy Substudy only)...................73
8.3. Safety Assessments .................................................................................................73
8.3.1. Incidental Gluten Exposure Assessment ....................................................74
8.3.2. Vital Signs ..................................................................................................74
8.3.2.1. Oral Temperature and Respiratory Rate....................................75
8.3.3. Electrocardiograms.....................................................................................75
8.3.4. Clinical Safety Laboratory Assessments ....................................................76
8.3.4.1. Alternative Facilities for Clinical Safety Laboratory 
Assessment ........................................................................................76
8.3.5. Physical Examinations................................................................................77
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8.3.6. Pregnancy Testing ......................................................................................77
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting .................77
8.4.1. Time Period and Frequency for Collecting AE and SAE Information.......78
8.4.1.1. Reporting SAEs to the Sponsor.................................................78
8.4.1.2. Recording Nonserious AEs and SAEs on the CRF...................79
8.4.2. Method of Detecting AEs and SAEs ..........................................................79
8.4.3. Follow-Up of AEs and SAEs......................................................................79
8.4.4. Regulatory Reporting Requirements for SAEs...........................................79
8.4.5. Environmental Exposure, Exposure During Pregnancy or 
Breastfeeding, and Occupational Exposure.....................................................80
8.4.5.1. Exposure During Pregnancy......................................................80
8.4.5.2. Exposure During Breastfeeding ................................................82
8.4.5.3. Occupational Exposure .............................................................82
8.4.6. Cardiovascular and Death Events...............................................................82
8.4.7. Disease -Related Events and/or Disease -Related Outcomes Not 
Qualifying as AEs or SAEs..............................................................................82
8.4.8. Adverse Events of Special Interest.............................................................82
8.4.8.1. Lack of Efficacy........................................................................82
8.4.9. Medical Device Deficiencies......................................................................83
8.4.10. Medication Errors.....................................................................................83
8.5. Pharmacokinetics ....................................................................................................84
8.6. Genetics...................................................................................................................85
8.6.1. Specified Genetics ......................................................................................85
8.7. Biomarkers ..............................................................................................................85
8.7.1. Residual Research Samples........................................................................86
8.8. Immunogenicity Assessments.................................................................................86
8.9. Health Economics ...................................................................................................87
9. STATISTICAL CONSIDERATIONS ................................................................................87
9.1. Statistical Hypotheses .............................................................................................87
9.1.1. Estimands....................................................................................................87
9.1.1.1. Part B.........................................................................................87
9.1.1.2. Part C.........................................................................................87
9.1.2. Multiplicity Adjustment..............................................................................88
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Final Protocol Amendment 3, 30 Jan 2024
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9.2. Analysis Sets ...........................................................................................................88
9.3. Statistical Analyses .................................................................................................89
9.3.1. General Considerations...............................................................................89
9.3.1.1. Analyses for Continuous Endpoints..........................................89
9.3.1.2. Missing Data Handling..............................................................90
9.3.2. Primary Endpoints/Estimands Analysis .....................................................90
9.3.2.1. Definition of Endpoints.............................................................90
9.3.2.2. Main Analytical Approach........................................................90
9.3.2.3. Sensitivity Analysis...................................................................90
9.3.3. Secondary Endpoints Analysis ...................................................................90
9.3.4. Tertiary/Exploratory Endpoints Analysis...................................................91
9.3.5. Pharmacokinetic Analysis ..........................................................................92
9.3.6. Safety Analyses ..........................................................................................93
9.3.7. Other Analyses............................................................................................93
9.4. Interim Analyses .....................................................................................................93
9.5. Sample Size Determination.....................................................................................94
10. SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS..........................................................................................................95
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations...............95
10.1.1. Regulatory and Ethical Considerations ....................................................95
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the 
Protocol or ICH GCP.........................................................................95
10.1.2. Financial Disclosure .................................................................................96
10.1.3. Informed Consent Process ........................................................................96
10.1.4. Data Protection .........................................................................................97
10.1.5. Committees Structure ...............................................................................98
10.1.5.1. Data Monitoring Committee ...................................................98
10.1.6. Dissemination of Clinical Study Data ......................................................98
10.1.7. Data Quality Assurance ............................................................................99
10.1.8. Source Documents..................................................................................100
10.1.9. Study and Site Start and Closure ............................................................101
10.1.10. Publication Policy.................................................................................101
10.1.11. Sponsor’s Medically Qualified Individual............................................101
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Final Protocol Amendment 3, 30 Jan 2024
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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10.2. Appendix 2: Clinical Laboratory Tests ...............................................................103
10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting ...................................................................104
10.3.1. Definition of AE .....................................................................................104
10.3.2. Definition of an SAE ..............................................................................105
10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During 
the Active Collection Period..........................................................................107
10.3.4. Reporting of SAEs..................................................................................110
10.4. Appendix 4: Contraceptive and Barrier Guidance ..............................................112
10.4.1. Male Participant Reproductive Inclusion Criteria (Parts A and B) ........112
10.4.2. Female Participant Reproductive Inclusion Criteria (Parts A and B).....112
10.4.3. Woman of Childbearing Potential ..........................................................113
10.4.4. Contraception Methods...........................................................................114
10.5. Appendix 5: Genetics..........................................................................................115
10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments .....116
10.7. Appendix 7: Kidney Safety Monitoring Guidelines ...........................................118
10.7.1. Laboratory Assessment of Change in Kidney Function and 
Detection of Kidney Injury............................................................................118
10.7.2. Age-Specific Kidney Function Calculation Recommendations.............118
10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI 
Equations .........................................................................................118
10.7.3. Adverse Event Grading for Kidney Safety Laboratory 
Abnormalities.................................................................................................118
10.8. Appendix 8: ECG Findings of Potential Clinical Concern .................................119
10.9. Appendix 9: Infusion-Related Reactions ............................................................121
10.10. Appendix 10: Common Terminology Criteria For Adverse Events .................123
10.11. Appendix 11: Marsh Criteria for Diagnosis of Celiac Disease.........................125
10.12. Appendix 12: Protocol Amendment History.....................................................126
10.13. Appendix 13: Abbreviations .............................................................................129
11. REFERENCES ................................................................................................................134
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Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 11
LIST OF TABLES
Table 1.
Projected Exposures and Safety Margins Following Repeat IV 
Doses of KAN-101 ...................................................................................51
Table 2.
PK Parameters Analyzed ..........................................................................92
Table 3.
Protocol Required Safety Laboratory Assessments................................103
Table 4.
CTCAE v5.0 Grades for GI Disorders Observed in KAN-101-01 
(FIH Study).............................................................................................124
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Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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1. PROTOCOL SUMMARY 
1.1. Synopsis 
Protocol Title:
A Phase 1b Open-Label/ Phase 2 Double-Blind Placebo-Controlled Study for 
Pharmacodynamic Activity, Pharmacokinetics, Safety and Tolerability of KAN-101 in 
Patients With Celiac Disease
Brief Title:
A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in 
People With Celiac Disease
Regulatory Agency Identification Number(s):
US IND Number:
19492
EudraCT Number:
N/A
ClinicalTrials.gov ID:
NCT05574010
Pediatric Investigational Plan Number:
N/A
Protocol Number:
KAN-101-02
Phase:
Phase 1b/2
Rationale:
The purpose of the study is to evaluate the safety, tolerability, PK parameters, and plasma 
biomarker (IL-2) response of participants with CeD treated with KAN-101.
Objectives, Endpoints, and Estimands:
Objectives
Endpoints
Estimands
Primary: 
Primary:
Primary: 
Part A:
Assess the safety and tolerability 
of KAN-101 in participants with 
CeD.
Part B:
Examine the biomarker response 
(IL-2) in peripheral blood 
following GC and after dosing.
Part A:
Incidence and severity of TEAEs as 
assessed by CTCAE.
Part B:
Change in magnitude of IL-2 
response pre-and post-GC in 
peripheral blood from baseline 
screening to Day 15.
Part A:
Not applicable.
Part B:
Estimand 1: This estimand is a 
treatment policy, observed data 
will be used for summary without 
regard to intercurrent events. It 
includes the following 5 attributes:
Population: Participant with celiac 
disease as defined by the Part B 
inclusion and exclusion criteria.
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Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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Objectives
Endpoints
Estimands
Part C: 
Compare change in biomarker 
(IL-2) response following GC in 
participants with CeD treated 
with KAN-101 versus PBO.
Part C:
Change in levels of IL-2 from 
pre-GC to post-GC on Day 15.
Variable: Change in magnitude of 
IL-2 response pre- and post-GC 
from baseline to Day 15.
Treatment conditions: 3 dose 
groups of KAN-101 or PBO.
Intercurrent Events: Intercurrent 
events will not be considered for 
analysis.
Population level summary: Mean, 
geometric mean ratio of post-GC 
vs pre-GC in IL-2 at Day -21 and 
Day 15 by treatment.
Part C:
Estimand 2: The primary estimand 
is the hypothetical estimand, which 
estimates the treatment effect of 
KAN-101 vs PBO for IL-2 under 
the scenario of no intercurrent 
events. It includes the following 5 
attributes:
Population: Participant with celiac 
disease as defined by the Part C 
inclusion and exclusion criteria.
Variable: log transformed IL-2 
change from pre-GC to post-GC on 
Day 15.
Treatment conditions: 3 dose 
groups of KAN-101 or PBO.
Intercurrent Events: Prohibited 
medication, incomplete GC on 
Day 15, and discontinuation of 
study intervention. All data 
collected after any intercurrent 
events will be excluded.
Population level summary: The 
LSM difference of the change from 
pre-GC to post-GC (log 
transformed) between each 
KAN-101 group and PBO.
Secondary: 
Secondary:
Secondary: 
Part A, Part B and Part C:
Assess the PK of multiple doses 
of KAN-101 in participants with 
CeD.
Part B and Part C:
Assess the safety and tolerability 
of KAN-101 in participants with 
CeD.
Part A, Part B and Part C:
KAN-101 plasma exposure as data 
permit: AUCinf, AUClast, Cmax, Tmax
and t½.
Part B and Part C:
Incidence and severity of TEAEs as 
assessed by the CTCAE.
Part A, Part B and Part C:
Not applicable.
Part B and Part C:
Not applicable.
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Objectives
Endpoints
Estimands
Tertiary/Exploratory: 
Tertiary/Exploratory:
Tertiary/Exploratory: 
Part A, Part B, and Part C:

To further characterize the PK 
profile of KAN-101 following 
multiple doses in participants 
with CeD.

To evaluate the immunogenicity 
of KAN-101. 
Part A:
Examine the biomarker response 
(IL-2) in peripheral blood 
following GC and after dosing.
Part B:
Assess the incidence of CeD 
symptoms before and after GC.
Assess durability of biomarker 
response in peripheral blood 
following GC.
Part C:
Assess the incidence of CeD 
symptoms in participants with 
CeD.
Compare change in biomarker 
response in participants with CeD 
and treated with KAN-101 versus 
PBO.
Assess durability of biomarker 
(IL-2) response in peripheral 
blood of participants with CeD 
and treated with KAN-101 versus 
PBO.
Part B and Part C Biopsy 
Substudy:
To evaluate the impact of 
KAN-101 on histology from EGD 
biopsy in participants with CeD.
Part A, Part B, and Part C:

KAN-101 PK parameters, as data 
permit: AUCinf (dn), AUClast (dn),
Cmax (dn), CL, V.

Incidence of development of ADA 
during the study.
Part A:
Change in magnitude of IL-2 
response pre-and-post GC in 
peripheral blood at Day 15.
Part B:
Incidence of CeD symptoms 
following GC as assessed by PROs 
including: CDSD v2.1, PGIC and 
PGIS.
Change in magnitude of IL-2 
response pre-and-post GC in 
peripheral blood from baseline (run-
in) to GC at Weeks 12, 24, and 36.
Change in magnitude of IL-2 
response pre- and post-GC in 
peripheral blood from Day 15 to 
Weeks 12, 24, and 36.
Part C:
Incidence of CeD symptoms as 
assessed by PROs including: CDSD 
v2.1, PGIC and PGIS.
Change in circulating levels of IL-2 
from pre-GC to post GC at Weeks 
12, 24, and 36.
Change in circulating levels of of 
various biomarkers from pre-dose to 
post-dose on Day 1, 4, and 7.
Change in circulating levels of IL-2
pre- and post-GC from Day 15 to 
Weeks 12, 24, and 36.
Part B and Part C Biopsy Substudy:
Change from baseline in histology 
(including, but not limited to, Marsh 
score, villous height crypt depth 
ratio, IEL counts) at Week 52.
Not applicable
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Protocol KAN-101-02
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Objectives
Endpoints
Estimands
Evaluate the potential relationship 
between histopathological state 
and response to 1 day GC.
Correlation between histological 
state, symptomatic response, and 
biomarker responses (IL-2).
Overall Design:
Study KAN-101-02 is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants 
with CeD on GFD. The 3 parts include:

Part A – Phase 1b, open-label, MAD study design to assess the safety, tolerability,
and PK of KAN-101 in adult participants (18 to 70 years inclusive) with histology-
confirmed CeD. All eligible participants will receive KAN-101.

Part A comprises 3 periods: 

Screening period: Up to 28 days before the first dose 

Treatment period: 7 days; administered IV study intervention on Day 1, 
Day 4, and Day 7

Observation/Follow-up period: 21 days, including post-dosing GC on 
Day 15 and safety follow-up visit on Day 28

All cohorts planned in Part A (Cohort 1: 1.2 mg/kg, Cohort 2: 3.0 mg/kg,) 
will employ inter-participant dosing whereby participants in each cohort 
will be dosed at least 14 days apart from the subsequent participants to 
monitor for the acute and subacute safety of KAN-101. 

A DSMB will review cumulative safety data through the dose 
escalation safety review period by cohort before opening a higher 
dose cohort. Initiation of the next dose cohort will commence once 
all participants in a cohort reach Day 15 prior to the GC, and upon 
acceptable safety review by DSMB and approval from sponsor.

Part B – Part B is a Phase 2, double-blind, PBO-controlled, parallel design study to 
characterize the biomarker response (plasma IL-2; primary endpoint) in peripheral 
blood following GC. Safety, tolerability, and PK of KAN-101 in adult participants 
(18 to 70 years inclusive) with histology-confirmed CeD will also be analyzed. 
Participants will be randomized 1:1:1:1 and stratified by participation in biopsy 
substudy to the following treatment groups: 

PBO (Group 1)

0.6 mg/kg (Group 2)
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
1.2 mg/kg (Group 3)

3.0 mg/kg (Group 4)

Initiation of Part B will occur following the DSMB review of available safety 
and PK data from Part A and the sponsor’s approval. 

Part B comprises 4 periods and 1 substudy: 

Screening period: ≤28 days

Run-in period: 21 days; eligible participants will undergo 1-day 9g GC 
on first day of run-in period (at least 21 days before administration of first 
dose of study drug) to confirm symptomatic response to oral GC.

Treatment period: 7 days; symptomatic responders to the run-in GC will 
be randomized 1:1:1:1 to 1 of the 4 treatment groups and administered 
study intervention IV for 3 administrations (1 administration every 3 days 
starting at Day 1).

Observation/follow-up period: 358 days, including post-dosing GC on 
Day 15 (to assess primary endpoint), post-dosing GC at Weeks 12, 24 and 
36 (to assess exploratory endpoints) and follow-up visits on Day 28 and 
Week 52.

Biopsy Substudy (at applicable sites only, up to approximately 50% of Part B 
cohort): includes collection of duodenal biopsies at screening and Week 52.

Part C – Part C is a Phase 2, double-blind, PBO-controlled, parallel design study to 
compare the biomarker response (plasma IL-2; primary endpoint) following GC on 
Day 15. Safety, tolerability, and PK of KAN-101 in adult participants (18 to 70 years 
inclusive) with histology-confirmed CeD will also be evaluated. Participants will be 
randomized 1:1:1:1 and stratified by participation in biopsy substudy to the following 
treatment groups: 

PBO (Group 1)

0.6 mg/kg (Group 2)

1.2 mg/kg (Group 3)

3.0 mg/kg (Group 4)

Initiation of Part C will occur following the DSMB review of available safety 
data from Part B and the sponsor’s approval. 
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Protocol KAN-101-02
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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
Part C will have 3 periods and 1 substudy:

Screening period: Day -28 to Day -1

Treatment period: Day 1 to Day 7; eligible participants will be 
randomized 1:1:1:1 to 1 of the 4 Treatment Groups and administered study 
intervention IV for 3 administrations (1 administration every 3 days 
starting at Day 1).

Follow-up period: Day after last dose till Day 364 (±3 days), including 
post-dosing GC on Day 15 (to assess primary endpoint), post-dosing GC 
at Weeks 12, 24 and 36 (to assess exploratory endpoints) and safety 
follow-up visits on Day 28 and Week 52.

Biopsy Substudy (at applicable sites only, up to approximately 50% of Part C 
cohort): includes collection of duodenal biopsies at screening and Week 52.
Number of Participants:
Part A: up to 12 participants will be randomized.
Part B: Approximately 16 participants (approximately 4 participants per treatment
group) will be randomized.
Part C: Approximately 104 participants (approximately 26 participants per treatment 
group) will be randomized.
Note: “Randomized” means a participant’s agreement to participate in a clinical study 
following completion of the informed consent process, screening, and randomization. 
A participant will be considered “enrolled” if the informed consent is not withdrawn prior to 
participating in any study activity.
Study Population:
Key inclusion and exclusion criteria are listed below.
For Part A and Part C: All inclusion/exclusion criteria must be met and confirmed prior to 
randomization.
For Part B: All inclusion criteria, except Inclusion Criterion #5, and all exclusion criteria 
must be met and confirmed prior to entry into the run-in period and GC assessment at 
Day 21. All inclusion criteria must be met and confirmed prior to randomization.
For Part B Biopsy Substudy: All inclusion criteria, except Inclusion Criterion #5, and all 
exclusion criteria must be met and confirmed prior to undergoing the screening biopsy. All 
inclusion/exclusion criteria must be met and confirmed prior to randomization.
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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For Part C Biopsy Substudy: All inclusion criteria and all exclusion criteria must be met 
and confirmed prior to undergoing the screening biopsy. All inclusion/exclusion criteria must 
be met and confirmed prior to randomization.
Inclusion Criteria 
Participants must meet the following key inclusion criteria to be eligible for enrollment into 
the study:
1. Participants aged 18 years to 70 inclusive (or the minimum age of consent in 
accordance with local regulations) at screening.
2. Previous diagnosis of CeD, based on documentation in the source data:

Positive celiac serology (eg, tissue transglutaminase IgA antibody and/or 
deamidated DGP IgG)
AND

Intestinal histology consistent with ≥ Marsh Type 2 or with evidence of 
villous atrophy.
3. Have HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02 (homozygotes 
or heterozygotes).
4. Negative or weak positive for transglutaminase IgA AND negative or weak 
positive for DGP-IgA/IgG during screening.

For tTG, a result of ≤10 U/mL will be considered negative or weak 
positive. 

For DGP, a result of <30 U/mL will be considered negative or weak 
positive.
5. Part B ONLY (prior to randomization): Demonstrates a symptomatic response 
following a 1-day oral GC performed during Run-in, defined as having at least 1 
moderate to severe GI symptom (either diarrhea, abdominal pain, bloating, or 
nausea) the day of the GC.
6. Have followed a gluten-free diet for ≥12 months immediately prior to study entry
(self-reported).
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Protocol KAN-101-02
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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Exclusion Criteria 
Participants with any of the following key characteristics/conditions will be excluded:
1. Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or 
symptoms with substantial villous atrophy (ex. Documented Marsh score 3c in 
source data) despite strict adherence to a GFD for at least 12 months in the 
absence of other disorders.
2. Selective IgA deficiency.
3. Positive for HLA-DQ8 (DQA1*03, DQB1*0302).
4. Known wheat allergy.
5. Known history of severe hypersensitivity reactions or anaphylaxis to gluten.
6. Previous oral GC within 12 months.
7. Active gastrointestinal disease (eg, inflammatory bowel disease, any forms of 
colitis, uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active 
GI infections).
8. Previous treatment with tolerance-inducing therapies for CeD.
Study Arms and Duration:
Study Intervention(s)
Intervention Name
KAN-101
PBO
Arm Name
(group of participants receiving 
a specific treatment or no 
treatment)
Part A: Cohort 1 and 2
Part B: Group 2, 3, and 4
Part C: Group 2, 3, and 4
Part A: N/A
Part B: Group 1
Part C: Group 1
Type
Drug
PBO
Dose Formulation
Solution in a single-use glass vial 
for dilution into saline bag for IV 
infusion
Solution for infusion in a saline 
bag
Unit Dose Strength(s)
 
 
 
N/A
Dosage Level(s)
PBO
Route of Administration
IV
IV
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
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Study Intervention(s)
Use
Experimental
Placebo
IMP or NIMP/AxMP
IMP
Placebo
Sourcing
Provided centrally by the sponsor.
Further details are presented in the 
IPM.
Provided locally by the site. 
Further details are presented in the 
IPM.
Packaging and Labeling
Study intervention will be 
provided in glass vials. Each vial 
will be labeled as required per 
country requirement.
In Part B and Part C, study 
intervention will be blinded once 
diluted in a saline bag.
Study intervention will be 
provided in saline bags. Each 
saline bag will be labeled as 
required per country requirement.
In Part B and Part C, study 
intervention will be blinded.
Study Arm(s)
Part A (open-label)
Arm Title
Cohort 1
Cohort 2
Arm Type
Experimental
Experimental
Arm Description
Participants will receive 1.2 mg/kg 
IV every 3 days starting on Day 1 
and ending on Day 7.
Participants will receive 3.0 mg/kg 
IV every 3 days starting on Day 1 
and ending on Day 7.
Associated Intervention 
Labels
KAN-101
KAN-101
Part B and Part C (double-blind)
Arm Title
Group 1
Group 2
Group 3
Group 4
Arm Type
Placebo
Experimental
Experimental
Experimental
Arm Description
Participants will 
receive PBO IV 
every 3 days 
starting on Day 1 
and ending on 
Day 7.
Participants 
will receive 
0.6 mg/kg IV 
every 3 days 
starting on 
Day 1 and 
ending on Day 
7.
Participants will 
receive 1.2 mg/kg IV 
every 3 days starting 
on Day 1 and ending
on Day 7. 
Participants 
will receive 
3.0 mg/kg IV 
every 3 days 
starting on 
Day 1 and 
ending on 
Day 7. 
Associated Intervention 
Labels
PBO
KAN-101
KAN-101
KAN-101
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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In Part A, the decision to proceed to the next dose level of KAN-101 (either an increase or a 
decrease) will be made by the study team and DSMB during the dose escalation safety 
period. If the decision is made to dose escalate, it is the sponsor’s discretion whether to 
proceed with escalation, expand the same dose or to modify doses based on emerging data. 
In Part B and Part C, no dose modification is allowed following selection of doses based on 
safety and tolerability of doses studied in Part A.
Statistical Methods:
Sample Size Determination
It is anticipated that the study will enroll approximately 126 – 132 participants:

Part A = 6-12 participants

Part B = approximately 16 participants

Part C = approximately 104 participants

Biopsy Substudy (at applicable sites only) will enroll up to approximately 50% 
participants enrolled in Part B and up to approximately 50% participants enrolled in 
Part C.
There is no formal power calculation for the open-label Part A. 
There is no formal power calculation for Part B. Descriptive summaries for primary and 
secondary endpoints will be reported.  
In Part C, assuming the mean difference in the change from pre-GC to post-GC of the 
log-transformed IL-2 levels on Day 15 is 2.37 between KAN-101 and PBO and the common 
standard deviation is 1.53, a sample size of 26 in each group will have 99% power, using a 
2-group t-test with a 5%, 2-sided significance level. The Part C sample size is large enough 
to offer insight into the exploratory endpoints. 
Primary Endpoint Analysis
For Part A, the primary endpoint is incidence and severity of TEAEs as assessed by 
CTCAE. 
For Part B, the primary endpoint is change in magnitude of IL-2 response pre- and post-GC 
in peripheral blood from baseline screening to Day 15.
For Part C, the primary endpoint is the change in IL-2 from pre-GC to post-GC on Day 15
in participants treated with KAN-101 versus PBO.
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
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CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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Main Analytical Approach: 

For Part A, number and percent of participants with TEAEs will be summarized 
by cohort, SOC, PT, and severity.

For Part B, the primary endpoint will be descriptively summarized by treatment 
using Estimand 1 for FAS. There is no statistical hypothesis testing.

For Part C, change in IL-2 from pre-GC to post-GC on Day 15 will be analyzed 
using ANOVA model.

The main analysis of the primary endpoint will be based on Estimand 2 using 
FAS. The LSM difference of the change from pre-GC to post-GC on Day 15
(log transformed) between each KAN-101 group and PBO will be provided; 
prohibited medications, incomplete GC at Day 15, and discontinuation of 
study intervention are intercurrent events. All data collected after any 
intercurrent events will be excluded. 

All statistical tests will be 2-tailed at a α = 0.05.
Secondary Endpoint Analysis 
For Part A, PK concentration and PK parameters will be descriptively summarized by 
treatment group. 
For Part B and Part C, number and percent of participants with TEAEs will be summarized 
by treatment, SOC, PT, and severity. PK concentration and PK parameters will be 
descriptively summarized by treatment group. Number of TEAEs (all-causality and 
treatment-related) and percent of participants with TEAEs will also be summarized by 
treatment period, treatment, SOC, PT, and severity. 
Ethical Considerations:
The overall potential benefit/risk of KAN-101 is considered favorable. Taking into account 
the measures to minimize risk to study participants, the potential risks identified in 
association with KAN-101 are justified by the anticipated benefits that may be afforded to
participants with CeD.
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1.2. Schema
1.2.1. Part A Study Design Schema
1.2.2. Part B Study Design Schema
Group 1: PBO N=4
Group 2: 0.6 mg/kg KAN-101 N=4
Group 3: 1.2 mg/kg KAN-101 N=4
Group 4: 3.0 mg/kg KAN-101 N=4
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Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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1.2.3. Part C Study Design Schema
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1.3. Schedule of Activities
The SoA table provides an overview of the protocol visits and procedures. Refer to the STUDY ASSESSMENTS AND 
PROCEDURES section of the protocol for detailed information on each procedure and assessment required for compliance with the 
protocol. 
The investigator may schedule visits (unplanned visits) in addition to those listed in the SoA table, in order to conduct evaluations or 
assessments required to protect the well-being of the participant.
1.3.1. Part A (Phase 1b – Open-Label)
Visit Identifier
Screen
Treatment Period
GC
FU
ET
Notes
Abbreviations used in this table 
may be found in Appendix 13.
Up to 
Day -1
(max 
length of 
screening 
is 28 days)
Day 1
Day 4
Day 7
Day 15
(fasted)
Day 28
ET
Day relative to start of study intervention (Day 1).
FU visit must occur between Day 25 and Day 31.
Visit Window
(± 3 d)
See Section 8.4.3 for follow-up AE and SAE assessments.
Screening Assessments
All screening should be done ≤28 days before the first dose. 
Informed consent
X
Informed consent should be obtained prior to undergoing any 
study-specific procedures.
See Section 10.1.3 for additional information.
Demographics and medical history
X
Includes disease history (symptoms at diagnosis and length of 
time on GFD).
Review eligibility criteria
X
X
HIV, HBV, HCV testing
X
HLA genotype and CeD serology
X
All participants will be assessed via central laboratory for HLA 
genotype and CeD serology (eg, tTG-IgA and DGP-IgG) at 
screening. 
For rescreening: HLA does not need to be repeated and CeD 
serology only needs to be repeated if >3 months have elapsed 
from last assessment.
12-Lead ECG
X
Not required for participants who have had an ECG within 12 
weeks prior to screening.
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Visit Identifier
Screen
Treatment Period
GC
FU
ET
Notes
Abbreviations used in this table 
may be found in Appendix 13.
Up to 
Day -1
(max 
length of 
screening 
is 28 days)
Day 1
Day 4
Day 7
Day 15
(fasted)
Day 28
ET
Day relative to start of study intervention (Day 1).
FU visit must occur between Day 25 and Day 31.
Visit Window
(± 3 d)
See Section 8.4.3 for follow-up AE and SAE assessments.
Clinical Procedures
Physical examination
X
X
X
See Section 8.3.5 for additional information.
Includes weight and height at screening only.
Vital signs
X
X
X
X
X
X
X
See Section 8.3.2 for additional information.
Includes weight and height at screening only.
Contraception check
X
X
X
X
X
X
X
Laboratory Assessments
See Section 8.3.4 for additional information.
See Appendix 2 for a list of Clinical Laboratory tests to be 
done.
For laboratory collection volumes, see the laboratory manual.
Safety laboratory tests
X
X
X
X
X
X
X
Includes hematology, blood chemistry, and urinalysis.
Days 1, 4, and 7: Samples/measurements taken pre-dose (at 
least 5 minutes prior to infusion). 
Day 15: Collected prior to GC.
Pregnancy test
X
X
X
X
X
X
X
Pregnancy test at screening must be serum; serum or urine tests 
are acceptable any day after screening.
Pregnancy test required if WOCBP has a missed period.
Pregnancy test must be negative before study intervention or 
GC is administered
Study Intervention and Other Treatments
See Section 6 for additional information.
Study intervention administration
X
X
X
See Section 6.1 for additional information.
Prior/concomitant treatment(s)
X
X
X
X
X
X
X
See Section 6.9 for additional information.
Incidental gluten exposure







Collected daily () as part of eDiary and reviewed at scheduled 
visits.
Gluten Challenge
X
Participants who withdraw from treatment and do not receive 3 
full doses should not receive GC (see Section 8.2.1).
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Visit Identifier
Screen
Treatment Period
GC
FU
ET
Notes
Abbreviations used in this table 
may be found in Appendix 13.
Up to 
Day -1
(max 
length of 
screening 
is 28 days)
Day 1
Day 4
Day 7
Day 15
(fasted)
Day 28
ET
Day relative to start of study intervention (Day 1).
FU visit must occur between Day 25 and Day 31.
Visit Window
(± 3 d)
See Section 8.4.3 for follow-up AE and SAE assessments.
Efficacy Assessments
See Section 8 for additional information.
CDSD© v2.1 self-administered by 
participant at home






X
Completed daily () from time of consent to Day 28; should be 
completed for at least a minimum of 7 consecutive days during 
screening at any time prior to the baseline visit (Day 1).
For re-screening: PRO only needs to be repeated if >3 months 
have elapsed from end of last PRO administration (and may not 
include the GC day).
PGIS
X
X
X
X
PGIC
X
X
X
PK/Immunogenicity Assessments
PK blood sample
X
X
X
PK sampling will be done pre-dose (at least 5 minutes prior to 
infusion) and end of infusion (+2) minutes. Additional sampling 
will be done at 45 (±2) minutes, 1 hour (±5 minutes), 1.5 hour 
(± 5 minutes), 2.5 hours (±5 minutes), 4.5 hours (±5 minutes)
and 7 hours (±5 minutes) after infusion start. 
An ET PK sample is required if ET visits is within 1 week of 
the last dose.  
ADA sample
X
X
X
X
On dosing days, samples collected pre-dose (at least 5 minutes 
prior to infusion).
Safety Assessments
See Section 8.3 for additional information.
Serious and nonserious AE 
monitoring
X
X
X
X
X
X
X
See Section 8.4 for additional information.
Biomarker Assessments
See study laboratory manual.
PBMC sample
X
X
Day 1: sample collected pre-dose (at least 5 minutes prior to 
infusion).
Day 15: sample collected prior to GC. 
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Visit Identifier
Screen
Treatment Period
GC
FU
ET
Notes
Abbreviations used in this table 
may be found in Appendix 13.
Up to 
Day -1
(max 
length of 
screening 
is 28 days)
Day 1
Day 4
Day 7
Day 15
(fasted)
Day 28
ET
Day relative to start of study intervention (Day 1).
FU visit must occur between Day 25 and Day 31.
Visit Window
(± 3 d)
See Section 8.4.3 for follow-up AE and SAE assessments.
Plasma IL-2 biomarker
X
X
X
X
See Section 8.2 for additional information.
Samples are collected pre dose (at least 5 minutes prior to dose)
and 4 hours (± 5 minutes) post dose on Day 1, 4 and 7.
Samples are collected pre-GC (at least 5 minutes prior to GC)
and 4 hours (± 15 minutes) post GC on Day 15.
Day 15: Participants who withdraw from treatment and do not 
receive 3 full doses should not have plasma samples collected.
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1.3.2. Part B (Phase 2 – Double-Blind)
Visit Identifier
Screen
Run-in
Treatment 
Period
GC
FU
W4
GC 
W12
GC
W24
GC
W36
FU
W52
ET
Notes
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -49
to 
Day -22
(fasted)
Day -21
(fasted)
Day -20 
to Day -1
Day 1
(fasted)
Day 
4
Day 
7
Day 15
(fasted)
Day 
28
Day 84
(fasted)
Day 
168
(fasted)
Day 
252
(fasted)
Day 
364
Day relative to start of study intervention 
(Day 1).
Run-in is a 1-day GC visit and must be at 
least 21 days prior to Day 1.
Visit Window
-3 d 
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
Screening Assessments
All screening should be done ≥21 days and 
≤49 days before the first dose. 
Informed consent
X
Informed consent should be obtained prior to 
undergoing any study-specific procedures. 
See Section 10.1.3 for additional information.
Demographics and 
medical history
X
Includes disease history (symptoms at 
diagnosis and length of time on GFD).
Review eligibility 
criteria
X
X
X
HIV, HBV, HCV testing
X
HLA genotype and CeD 
serology
X
All participants will be assessed via central 
laboratory for HLA genotype and CeD 
serology (eg, tTG-IgA and DGP-IgG) at 
screening to confirm eligibility prior to 
screening GC. 
For rescreening: HLA does not need to be 
repeated and CeD serology only needs to be 
repeated if >3 months have elapsed from last 
assessment.
12-Lead ECG
X
Not required for participants who have had an 
ECG within 12 weeks prior to screening.
Clinical Procedures
Physical examination
X
X
X
See Section 8.3.1 for additional information.
Vital signs
X
X
X
X
X
X
X
X
X
X
X
X
See Section 8.3.2 for additional information.
Includes weight and height at screening only.
Contraception check
X
X
X
X
X
X
X
X
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 30
Visit Identifier
Screen
Run-in
Treatment 
Period
GC
FU
W4
GC 
W12
GC
W24
GC
W36
FU
W52
ET
Notes
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -49
to 
Day -22
(fasted)
Day -21
(fasted)
Day -20 
to Day -1
Day 1
(fasted)
Day 
4
Day 
7
Day 15
(fasted)
Day 
28
Day 84
(fasted)
Day 
168
(fasted)
Day 
252
(fasted)
Day 
364
Day relative to start of study intervention 
(Day 1).
Run-in is a 1-day GC visit and must be at 
least 21 days prior to Day 1.
Visit Window
-3 d 
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
Laboratory Assessments
See Section 8.3.4 for additional information.
See Appendix 2 for a list of Clinical 
Laboratory tests to be done.
For laboratory collection volumes, see the 
study laboratory manual.
Safety laboratory tests
X
X
X
X
X
X
X
X
Includes blood chemistry, hematology, and 
urinalysis.

At least 8 hours fasting is required before 
collecting samples for safety laboratory tests
(see Section 8.3.4).
Samples/ measurements taken pre-dose (at 
least 5 minutes prior to infusion).
Collected prior to GC.
Pregnancy test
X
X
X
X
X
X
X
X
X
X
X
Pregnancy test at screening must be serum; 
serum or urine tests are acceptable on dosing 
days (Day 1, 4, and 7).
Pregnancy test must be negative before study 
intervention or GC is administered. May also 
perform urine pregnancy test prior to EGD
per local practice guidelines
ET: Only needed if ET occurs up to Day 28.
Study Intervention and Other Treatments
See Section 6 for additional information.
Study intervention 
administration
X
X
X
See Section 6.1 for additional information.
Prior/concomitant 
treatment(s)
X
X
X
X
X
X
X
X
X
X
X
X
See Section 6.9 for additional information.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 31
Visit Identifier
Screen
Run-in
Treatment 
Period
GC
FU
W4
GC 
W12
GC
W24
GC
W36
FU
W52
ET
Notes
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -49
to 
Day -22
(fasted)
Day -21
(fasted)
Day -20 
to Day -1
Day 1
(fasted)
Day 
4
Day 
7
Day 15
(fasted)
Day 
28
Day 84
(fasted)
Day 
168
(fasted)
Day 
252
(fasted)
Day 
364
Day relative to start of study intervention 
(Day 1).
Run-in is a 1-day GC visit and must be at 
least 21 days prior to Day 1.
Visit Window
-3 d 
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
EGD with biopsy 
(Substudy Only)
X
X
For participants in Biopsy Substudy Only.
The EGD with biopsy will be performed once 
all other inclusion criteria, except for the 
criteria around symptoms following GC, are 
fulfilled.
Biopsy must be collected at least 4 days prior 
to run-in GC.
Approximately 6 duodenal biopsies.
For rescreening: EGD with biopsy does not 
need to be repeated unless >3 months have 
elapsed from last assessment.
Gluten Challenge
X
X
X
X
X
See Section 8.2.1for additional information.
During the run-in period: 1-day GC on site by 
patients ≥3 weeks before the first 
administration of study intervention (Day 1).
Participants who withdraw from treatment 
and do not receive 3 full doses should not 
receive GC.
Efficacy Assessments
See Section 8 for additional information.
Plasma IL-2 biomarker
X
X
X
X
X
See Section 8.2.1 for additional information.
At every GC, plasma IL-2 sample should be 
collected at least 5 minutes before and 4 
hours (± 15 minutes) after GC.
Participants who withdraw from treatment 
and do not receive 3 full doses should not 
have plasma samples collected.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 32
Visit Identifier
Screen
Run-in
Treatment 
Period
GC
FU
W4
GC 
W12
GC
W24
GC
W36
FU
W52
ET
Notes
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -49
to 
Day -22
(fasted)
Day -21
(fasted)
Day -20 
to Day -1
Day 1
(fasted)
Day 
4
Day 
7
Day 15
(fasted)
Day 
28
Day 84
(fasted)
Day 
168
(fasted)
Day 
252
(fasted)
Day 
364
Day relative to start of study intervention 
(Day 1).
Run-in is a 1-day GC visit and must be at 
least 21 days prior to Day 1.
Visit Window
-3 d 
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
CDSD© v2.1 self-
administered by 
participant at home
X










X
Completed daily () from time of consent to 
Week 52; CDSD v2.1 should be completed 
for at least a minimum of 7 consecutive days 
during screening at any time prior to run-in 
GC visit (Day -21) for Part B. 
For re-screening: CDSD v2.1 only needs to 
be repeated if >3 months have elapsed from 
end of last PRO administration (and may not 
include the GC day).
Incidental gluten 
exposure check










X
Included in the daily () eDiary and 
reviewed at study visits.
PGIS
X
X
X
X
X
X
X
X
PGIC
X
X
X
X
X
X
X
PK/ Immunogenicity Assessments
PK blood sample
X
X
X
PK sampling collected pre-dose (at least 5 
minutes prior to infusion) and end of 
infusion (+2) minutes. Additional sampling 
will be done at 2.5 hours (±5 minutes) and 4 
hours (±5 minutes) after infusion start. 
An ET PK sample is required if ET visits is 
within 1 week of the last dose.
ADA sample
X
X
X
X
X
X
X
X
On dosing days, samples collected pre-dose 
(at least 5 minutes prior to infusion).
Safety Assessments
See Section 8.3 for additional information.
Serious and nonserious 
AE monitoring
X
X
X
X
X
X
X
X
X
X
X
X
See Section 8.4 for additional information.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 33
1.3.3. Part C (Phase 2 – Double-Blind)
Visit Identifier
Screen
Treatment Period
Follow-Up Period
ET
Notes
GC
FU
W4
GC
W12
GC
W24
GC
W36
FU
W52
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -28 
to Day-1
Day 1
(fasted)
Day 4
(fasted)
Day 7
(fasted)
Day 15
(fasted)
Day 28 Day 84
(fasted)
Day 168
(fasted)
Day 252
(fasted)
Day 364
(fasted)
Day relative to start of study intervention (Day 1).
Visit Window
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
Screening Assessments
Informed consent
X
Informed consent should be obtained prior to 
undergoing any study-specific procedures. 
See Section 10.1.3 for additional information.
Demographics and 
medical history
X
Includes disease history (symptoms at diagnosis 
and length of time on GFD).
Review eligibility criteria
X
X
HIV, HBV, HCV testing
X
HLA genotype and CeD 
serology
X
All participants will be assessed via central 
laboratory for HLA genotype and CeD serology 
(eg, tTG-IgA and DGP-IgG) at screening to 
confirm eligibility prior to screening GC. 
For rescreening: HLA does not need to be repeated 
and CeD serology only needs to be repeated if >3 
months have elapsed from last assessment.
12-Lead ECG
X
Not required for participants who have had an ECG 
within 12 weeks prior to screening.
Clinical Procedures
Physical examination
X
X
X
See Section 8.3.1 for additional information.
Vital signs
X
X
X
X
X
X
X
X
X
X
X
See Section 8.3.2 for additional information.
Includes weight and height at screening only.
Orthostatic vital signs, 
oral temperature and RR
X
X
X
See Section 8.3.2.1 for additional information.
To be measured pre-dose and at approximately 45 
mins, 2 hours, and then, every 2 hours (until 
discharge) post end-of-infusion.
Additional measurements may be taken in case of 
treatment-emergent, clinically significant 
orthostatic hypotension or syncope. See Section 
8.3.2.
Contraception check
X
X
X
X
X
X
X
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 34
Visit Identifier
Screen
Treatment Period
Follow-Up Period
ET
Notes
GC
FU
W4
GC
W12
GC
W24
GC
W36
FU
W52
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -28 
to Day-1
Day 1
(fasted)
Day 4
(fasted)
Day 7
(fasted)
Day 15
(fasted)
Day 28 Day 84
(fasted)
Day 168
(fasted)
Day 252
(fasted)
Day 364
(fasted)
Day relative to start of study intervention (Day 1).
Visit Window
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
Laboratory Assessments
See Section 8.3.4 for additional information.
See Appendix 2 for a list of Clinical Laboratory 
tests to be done.
For laboratory collection volumes, see the study 
laboratory manual.
Safety laboratory tests
X
X
X
X
X
X
X
X
X
X
Includes blood chemistry, hematology, and 
urinalysis pre-dose/GC (approximately 5 minutes 
before) collection (after at least 8 hours fast) (see 
Section 8.3.4).
Additional safety labs (hematology and chemistry) 
may be collected in case of treatment emergent, 
clinically significant, orthostatic hypotension, 
syncope or treatment-related TEAE of Grade 3 or 
above (see Section 8.3.4).
Pregnancy test
X
X
X
X
X
X
X
X
X
X
Pregnancy test at screening must be serum; serum 
or urine tests are acceptable on dosing days (Days
1, 4, and 7).
Pregnancy test must be negative before study 
intervention or GC is administered. May also 
perform urine pregnancy test prior to EGD per 
local practice guidelines.
ET: Only needed if ET occurs up to Day 28.
Study Intervention and Other Treatments
Study Intervention and Other Treatments.
Study intervention 
administration
X
X
X
See Section 6.1 for additional information.
Prior/concomitant 
treatment(s)
X
X
X
X
X
X
X
X
X
X
X
See Section 6.9 for additional information.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 35
Visit Identifier
Screen
Treatment Period
Follow-Up Period
ET
Notes
GC
FU
W4
GC
W12
GC
W24
GC
W36
FU
W52
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -28 
to Day-1
Day 1
(fasted)
Day 4
(fasted)
Day 7
(fasted)
Day 15
(fasted)
Day 28 Day 84
(fasted)
Day 168
(fasted)
Day 252
(fasted)
Day 364
(fasted)
Day relative to start of study intervention (Day 1).
Visit Window
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
EGD with biopsy 
(Substudy Only)
X
X
For participants in Biopsy Substudy Only.
The EGD with biopsy will be performed once all 
other inclusion criteria are met.
Biopsy must be collected at least 4 days prior to
dosing (Day 1).
Approximately 6 duodenal biopsies.
For rescreening: EGD with biopsy does not need to 
be repeated unless >3 months have elapsed from 
last assessment.
Gluten Challenge
X
X
X
X
See Section 8.2.1 for additional information.
Participants who withdraw from treatment and do 
not receive 3 full doses should not receive GC.
PD Assessments
See Section 8 for additional information.
Plasma IL-2 biomarker
X
X
X
X
See Section 8.2.2 for additional information.
At every GC visit, plasma IL-2 sample should be 
collected at least 5 minutes before and 4 hours (± 
15 minutes) after GC.
Participants who withdraw from treatment and do 
not receive 3 full doses should not have plasma 
samples collected.
Other plasma biomarkers
X
X
X
See Section 8.7 for additional information.
At every dosing visit, plasma samples should be 
collected at least 5 minutes before and 4 hours 
(±15 minutes) after dosing.
Additional plasma samples should be collected as 
soon as practically feasible, in an event of 
treatment emergent, clinically significant 
orthostatic hypotension, syncope, or treatment-
related TEAE, Grade 3 or above.
Participants who withdraw from treatment and do 
not receive 3 full doses should not have plasma 
samples collected.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 36
Visit Identifier
Screen
Treatment Period
Follow-Up Period
ET
Notes
GC
FU
W4
GC
W12
GC
W24
GC
W36
FU
W52
Abbreviations used in 
this table may be found 
in Appendix 13.
Day -28 
to Day-1
Day 1
(fasted)
Day 4
(fasted)
Day 7
(fasted)
Day 15
(fasted)
Day 28 Day 84
(fasted)
Day 168
(fasted)
Day 252
(fasted)
Day 364
(fasted)
Day relative to start of study intervention (Day 1).
Visit Window
±3 d
±5 d
±5 d
±5 d
±3 d
See Section 8.4.3 for follow-up AE and SAE 
assessments.
CDSD© v2.1 self-
administered by 
participant at home
X








X
X
CDSD v2.1 should be completed for at least a 
minimum of 7 consecutive days during screening. 
For re-screening: CDSD v2.1 only needs to be 
repeated if >3 months have elapsed from end of 
last PRO administration.
Incidental gluten 
exposure check









X
X
Included in the daily eDiary and reviewed at study 
visits.
PGIS
X
X
X
X
X
X
X
X
PGIC
X
X
X
X
X
X
X
PK/ Immunogenicity Assessments
PK blood sample
X
X
X
PK sampling collected pre-dose (at least 5 minutes 
prior to infusion) and end of infusion (+2) minutes. 
Additional sampling will be done at 2.5 hours (±5 
minutes) and 4 hours (±5 minutes) after infusion 
start. 
An ET PK sample is required if ET visits is within 
1 week of the last dose.
ADA sample
X
X
X
X
X
X
X
X
On dosing days, samples collected pre-dose (at least 
5 minutes prior to infusion).
Safety Assessments
See Section 8.3 for additional information.
Serious and nonserious 
AE monitoring
X








X
X
See Section 8.4 for additional information.
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 37
2. INTRODUCTION
2.1. Study Rationale 
The purpose of the study is to evaluate the safety, tolerability, PK parameters, and plasma 
biomarker (IL-2) response of participants with CeD treated with KAN-101.
2.2. Background 
2.2.1. Celiac Disease
Celiac disease (CeD) is an inherited autoimmune disorder that affects the digestive process of 
the small intestine. When a patient with CeD consumes gluten, that individual’s immune 
system responds by attacking the small intestine, thereby inhibiting the absorption of 
nutrients. CeD can present with a variety of gastrointestinal (GI) symptoms, include diarrhea, 
bloating, flatulence and abdominal pain, and non-GI symptoms such as anemia and vitamin 
deficiencies (Halfdanarson et al, 2006) (Rubio-Tapia et al, 2013). Undiagnosed and untreated 
CeD has been linked to the development of other autoimmune disorders, nutritional disorders 
such as osteoporosis and infertility, and neurological conditions (Green et al, 2001; Green & 
Jabri, 2006).
It has been recently estimated that 0.7% of the world-wide population has CeD, with global 
prevalence rates on the rise (Singh et al, 2018). CeD is strongly associated with the Human 
Leukocyte Antigen (HLA)-DQA1 and HLA-DQB1 loci (HLA-1*05, HLA-DQB1*02; 
commonly referred to as HLA-DQ2.5) which is present in approximately 90% of CeD 
patients (Sollid et al, 1989; Sollid et al, 2012). The pathology observed in CeD patients is 
driven by the adaptive immune response specific to proteins generated in the digestive 
system after ingestion of gluten, which results in autoimmune-like pathology in the small 
intestine (Sollid & Jabri, 2013). Diagnosis is typically made by a combination of positive 
IgA, tTG, and/or IgG, DGPs, and small intestinal biopsy demonstrating villous abnormalities 
while on a gluten-containing diet or following a GC (Halfdanarson et al, 2006; Rubio-Tapia 
et al, 2013). 
There is currently no pharmaceutical treatment approved for the management of CeD. 
Patients manage their symptoms by strict adherence to a GFD, which often presents a 
substantial logistical and financial burden (See et al, 2015). The effectiveness of the GFD is 
limited not only by motivation, access, and expense, but by uncertainty related to potential 
gluten content of certain medications and supplements. Adherence to the strict GFD is also 
limited by the ubiquity of gluten contamination in many gluten-free foods. Several studies 
have shown incomplete histological normalization of small bowel mucosa despite a strict 
GFD, with persistent villous atrophy seen in up to 79% of treated patients (See et al, 2015). 
In addition to adherence challenges, some patients report persistent, life-affecting symptoms 
despite attempting to adhere to the GFD. Patients with CeD who adhere to a strict GFD 
continue to have a heavy burden of care. 
Thus, there remains a strong unmet medical need for pharmacologic interventions to help 
alleviate the growing disease burden of CeD.
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 38
2.2.2. KAN-101
KAN-101 is composed of a synthetic liver-targeting 
 to a 
synthetic 
 peptide domain of wheat alpha gliadin (KAN0009) recognized 
by the HLA-DQ2.5 haplotype. KAN0009 does not bind to the HLA DQ8 molecule. KAN-
101 is a liquid formulation drug product administered parenterally via an IV infusion.
KAN-101 harnesses natural tolerogenic pathways in the liver (Thomson & Knolle, 2010) to 
reprogram pathogenic immune cells to become tolerant toward specific antigens. KAN-101 
specifically targets the immune cells that drive CeD and leaves the otherwise healthy 
components of the immune system intact to perform their natural, protective functions. The 
proposed mechanism of action of KAN-101 is receptor-mediated internalization of the 
molecule into liver cells, and the induction of immune tolerance through subsequent 
KAN0009 gliadin peptide antigen presentation on the major histocompatibility complex 
(MHC; class I and II). After KAN-101 internalization into liver cells, the KAN0009 peptide 
is released from the GP portion and processed intracellularly for presentation by MHC and 
signaling to gliadin-specific T cells for the induction of immune tolerance and subsequent 
amelioration of gut pathology.
The mechanisms by which KAN-101 induces immunologic tolerance are mediated by:

Deletion of antigen-specific T cells

Induction of anergy/clonal exhaustion of antigen-specific T cells

Induction of regulatory T cells which control the antigen-specific T cell response
For more information on the nonclinical findings, please see the KAN-101 IB. 
2.2.3. Clinical Overview
KAN-101 was evaluated in a FIH Phase 1 study in patients with CeD on a GFD
(KAN-101-01). This was a 2-part, multicenter study designed to examine the safety and 
tolerability of SAD (Part A) and MAD (Part B) of KAN-101. A total of 41 participants 
received at least 1 dose of KAN-101 (0.15 mg/kg, 0.3 mg/kg, 0.6 mg/kg, 1.2 mg/kg, and 1.5
mg/kg) during the study.
In Study KAN-101-01 administration of KAN-101 was effective at inducing T-cell tolerance:

Three doses of KAN-101, administered 3 days apart, at 0.15, 0.3 and 0.6 mg/kg dose 
levels was effective in inducing T cell tolerance to gliadin. KAN-101 treated patients 
exhibited minimal change or a decrease in the gliadin-specific T-cell response 
following GC while placebo patients exhibited an increase in the gliadin-specific T-
cell response following GC.

KAN-101 also modified the immediate immune reaction upon ingestion of gluten by 
CeD patients in a dose-dependent manner. Patients treated with 3 doses of 0.6 mg/kg 
KAN-101, administered 3 days apart, exhibited lower median plasma IL-2 levels 
090177e19fcc12ed\Approved\Approved On: 30-Jan-2024 19:45 (GMT)
CCI
CCI

KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 39
within hours of GC compared to placebo or 0.15 and 0.3 mg/kg KAN-101 dose 
levels. 
KAN-101 demonstrated an acceptable safety and tolerability profile after single and multiple 
doses at all dose levels tested in the KAN-101-01 study. There were no deaths, SAEs, Grade 
3 TEAEs, or DLTs observed. TEAEs were consistent with CeD patients upon gluten 
ingestion (ie, nausea, emesis, abdominal pain, headache, and diarrhea). No clinically relevant 
trends were observed for changes in vital signs, physical examination, laboratory tests, or 
ECG results. There were no meaningful correlations between the frequency of TEAEs and 
study drug dose level. There was an increased frequency of subjects who experienced GI 
AEs in the total drug-treated group than in the placebo group. No MTD of KAN-101 was 
identified in KAN-101-01 and no meaningful safety differences were observed among 
treatment groups during the study.
Preliminary data from the KAN-101-01 study suggests rapid elimination with mean half-life 
ranging from 3.74 to 36.8 minutes across 0.15 mg/kg to 1.2 mg/kg doses, following single or 
repeat IV infusions of KAN-101. The mean KAN-101 maximum exposure (Cmax) and 
systemic exposure (AUC) appeared to exhibit approximate dose proportionality across 0.15 
to 1.2 mg/kg dose range. With repeat dosing, there was no accumulation of KAN-101 which 
was in concordance with the rapid elimination. 
In KAN-101-01 study, 3 doses of KAN-101 0.15 mg/kg, 0.3 mg/kg and 0.6 mg/kg given 
every 3 days exhibited minimal changes or a decrease in the gliadin-specific T-cell response 
compared to placebo that exhibited an increased T-cell response following GC. In addition, 3
doses of KAN-101 0.6 mg/kg lowered median IL-2 levels after GC compared to the IL-2 
levels in Placebo or 0.15 mg/kg and 0.3 mg/kg KAN-101 groups. For more information on 
the nonclinical and previous clinical findings, please see the KAN-101 IB.
Based on nonclinical and clinical findings from the FIH study (KAN-101-01), the sponsor is 
initiating this Phase 1b/2 study of KAN-101 in adult participants with CeD. 
2.3. Benefit/Risk Assessment
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of KAN-101 may be found in the IB, which is the SRSD for this study. 
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2.3.1. Risk Assessment
Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
Study Intervention(s) [KAN-101 and PBO]
Potential for exacerbation of gastrointestinal 
symptoms associated with CeD, which may 
include and are not necessarily limited to AEs of 
headache, dizziness, fatigue/lethargy, nausea, 
vomiting, abdominal pain, diarrhea, constipation, 
skin rash, and abdominal tenderness.
The potential risks are based on the mechanism of 
action of KAN-101 and other similar therapeutic 
investigational immunomodulatory therapies in 
CeD (Daveson et al, 2017; Truitt et al, 2019).
AEs and clinical laboratory results will be 
monitored on an ongoing basis and managed 
according to established standard of care.
Use of a placebo arm in Part B and Part C.
The use of a placebo represents a potential risk. 
Participants who experience worsening of CeD 
may discontinue from the study and may receive 
SOC treatment at the investigator’s discretion.
IV infusions will be administered over 30 minutes
every 3 days during study treatment period.
IRR are known risks associated with IV infusions.
IRR will be monitored and specific guidance on
acute and prophylactic treatment of IRRs and 
recommendations for future infusions of KAN-
101 are provided in Appendix 9.
Potential hypersensitivity reactions may occur and 
include skin reaction, mucosal tissue reaction, 
respiratory reaction, GI reactions, and CV 
reactions. 
Similar to other biologic molecules.
Participants will be closely monitored on site for 4 
hours post infusion for signs of any reaction.
KAN-101 is a liver targeting agent.
Although FIH Study KAN-101-01 and nonclinical 
data show that KAN-101 had no significant impact 
on the liver (eg, liver enzyme levels and 
histopathology), KAN-101’s potential impact on 
liver enzymes will continue to be evaluated in the 
clinical setting.
Transaminase levels will be closely monitored and 
are included in safety laboratory assessments. 
Participants with ALT, AST, or ALP > 1.5 x ULN 
are not eligible for enrollment in KAN-101-02.
Participants considered to have a potential case of 
Hy’s law will lead to a cessation of clinical dosing 
and participant will be followed to resolution. 
Study Procedures
KAN-101-02 includes a single 1-day GC (9 g 
gluten) in Part A, up to five 1-day GC (9 g gluten) 
Known AEs associated with GC are expected, 
which may include and are not necessarily limited 
Participants will consume the GC in clinic and 
will be monitored for AEs associated with GC and 
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Potential Risk of Clinical Significance
Summary of Data/Rationale for Risk
Mitigation Strategy
in Part B, and up to four 1-day GC (9 g gluten) in 
Part C.
to AEs of headache, dizziness, fatigue/lethargy, 
nausea, vomiting, abdominal pain, diarrhea, 
constipation, skin rash, and abdominal tenderness.
managed according to established standard of 
care. 
KAN-101-02 Part B and Part C include a biopsy 
substudy with 2 EGD with biopsy.
EGD with biopsy carries a small risk of bowel 
perforation. Duodenal biopsies also carry the risk 
of duodenal hematoma.
EGD for the study will be performed by qualified 
and experienced gastroenterologists.
Other 
The COVID-19 pandemic may pose risks to study 
participation.
Participants may have increased risk of SARS-
CoV-2 infection by undergoing a study procedure 
at a study facility.
Inclusion of COVID-19 specific screening 
procedures and assessments per local 
requirements.
Enrollment of non-GC responders into the Part B 
study may confound study primary endpoint. 
Results could potentially be confounded by non-
symptomatic participants.
Eligibility criteria and a pre-randomization GC are 
required to ensure that symptomatic participants 
are randomized.
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2.3.2. Benefit Assessment
There is no individual health benefit for participating in the study. However, participants 
contribute to the process of developing new therapies for CeD for which there remains a 
strong unmet medical need for pharmacologic interventions to help alleviate the growing 
disease burden.
2.3.3. Overall Benefit/Risk Conclusion
The overall potential benefit/risk of KAN-101 is considered favorable.
Taking into account the measures to minimize risk to study participants, the potential risks 
identified in association with KAN-101 are justified by the anticipated benefits that may be 
afforded to participants with CeD.
3. OBJECTIVES, ENDPOINTS, AND ESTIMANDS
Objectives
Endpoints
Estimands
Primary: 
Primary:
Primary: 
Part A:
Assess the safety and tolerability 
of KAN-101 in participants with 
CeD.
Part B:
Examine the biomarker response 
(IL-2) in peripheral blood 
following GC and after dosing.
Part C: 
Compare change in biomarker 
(IL-2) response following GC in 
participants with CeD  treated 
with KAN-101 versus PBO.
Part A:
Incidence and severity of TEAEs as 
assessed by CTCAE.
Part B:
Change in magnitude of IL-2 
response pre-and post-GC in 
peripheral blood from baseline 
screening to Day 15.
Part C:
Change in levels of IL-2 from pre-
GC to post-GC on Day 15.
Part A:
Not applicable.
Part B:
Estimand 1: This estimand is a 
treatment policy, observed data 
will be used for summary without 
regard to intercurrent events. It 
includes the following 5 attributes:
Population: Participant with celiac 
disease as defined by the Part B 
inclusion and exclusion criteria.
Variable: Change in magnitude of 
IL-2 response pre- and post-GC 
from baseline to Day 15.
Treatment conditions: 3 dose 
groups of KAN-101 or PBO.
Intercurrent Events: Intercurrent 
events will not be considered for 
analysis.
Population level summary: Mean, 
geometric mean ratio of post-GC 
vs pre-GC in IL-2 at Day -21 and 
Day 15 by treatment.
Part C:
Estimand 2: The primary estimand 
is the hypothetical estimand, which 
estimates the treatment effect of 
KAN-101 vs PBO for IL-2 under 
the scenario of no intercurrent 
events. It includes the following 5 
attributes:Population: Participant 
with celiac disease as defined by 
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Objectives
Endpoints
Estimands
the Part C inclusion and exclusion 
criteria.
Variable: log transformed IL-2 
change from pre-GC to post-GC on 
Day 15.
Treatment conditions: 3 dose 
groups of KAN-101 or PBO.
Intercurrent Events: Prohibited 
medication, incomplete GC on Day 
15, and discontinuation of study 
intervention. All data collected 
after any intercurrent events will be 
excluded.
Population level summary: The 
LSM difference of the change from 
pre-GC to post-GC (log 
transformed) between each KAN-
101 group and PBO.
Secondary: 
Secondary:
Secondary: 
Part A, Part B and Part C:
Assess the PK of multiple doses 
of KAN-101 in participants with 
CeD.
Part B and Part C:
Assess the safety and tolerability 
of KAN-101 in participants with 
CeD.
Part A, Part B and Part C:
KAN-101 plasma exposure as data 
permit: AUCinf, AUClast, Cmax, Tmax
and t½.
Part B and Part C:
Incidence and severity of TEAEs as 
assessed by the CTCAE.
Part A, Part B and Part C:
Not applicable.
Part B and Part C:
Not applicable.
Tertiary/Exploratory: 
Tertiary/Exploratory:
Tertiary/Exploratory: 
Part A, Part B, and Part C:

To further characterize the PK 
profile of KAN-101 following 
multiple doses in participants 
with CeD.

To evaluate the immunogenicity 
of KAN-101. 
Part A:
Examine the biomarker response 
(IL-2) in peripheral blood 
following GC and after dosing.
Part B:
Assess the incidence of CeD 
symptoms before and after GC.
Assess durability of biomarker 
response in peripheral blood 
following GC.
Part A, Part B, and Part C:

KAN-101 PK parameters, as data 
permit: AUCinf (dn), AUClast (dn),
Cmax (dn), CL, V

Incidence of development of ADA 
during the study.
Part A:
Change in magnitude of IL-2 
response pre-and-post GC in 
peripheral blood at Day 15.
Part B:
Incidence of CeD symptoms 
following GC as assessed by PROs 
including: CDSD v2.1, PGIC and 
PGIS.
Change in magnitude of IL-2 
response pre-and-post GC in 
peripheral blood from baseline (run-
in) to GC at Weeks 12, 24, and 36.
Change in magnitude of IL-2 
response pre- and post-GC in 
Not applicable
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Objectives
Endpoints
Estimands
Part C:
Assess the incidence of CeD 
symptoms in participants with 
CeD.
Compare change in biomarker 
response in participants with CeD 
and treated with KAN-101 versus 
PBO.
Assess durability of biomarker 
(IL-2) response in peripheral 
blood of participants with CeD 
and treated with KAN-101 versus 
PBO.
Part B and Part C Biopsy 
Substudy:
To evaluate the impact of KAN-
101 on histology from EGD 
biopsy in participants with CeD.
Evaluate the potential relationship 
between histopathological state 
and response to 1 day GC.
peripheral blood from Day 15 to 
Weeks 12, 24, and 36.
Part C:
Incidence of CeD symptoms as 
assessed by PROs including: CDSD 
v2.1, PGIC and PGIS.
Change in circulating levels of IL-2 
from pre-GC to post GC at Weeks 
12, 24, and 36.
Change in circulating levels of 
various biomarkers from pre-dose to 
post-dose on Day 1, 4, and 7.
Change in circulating levels of IL-2 
pre- and post-GC from Day 15 to 
Weeks 12, 24, and 36.
Part B and Part C Biopsy Substudy:
Change from baseline in histology 
(including, but not limited to, Marsh 
score, villous height crypt depth 
ratio, IEL counts) at Week 52.
Correlation between histological 
state, symptomatic response, and 
biomarker responses (IL-2). 
4. STUDY DESIGN
4.1. Overall Design
Study KAN-101-02 is a 3-part, multicenter Phase 1b/2 study of KAN-101 in participants 
with CeD on GFD. The 3 parts include:

Part A – Open-label, multiple ascending dose

Part B – Double-blind, PBO-controlled, parallel design

Part C – Double-blind, PBO-controlled, parallel design
Anokion as the sponsor of the study, is delegating to Pfizer all obligations for conduct of 
Study, including responsibility for preparing the protocol, and overall conduct and oversight 
of the study, including contracting with study sites. Kanyos Bio, Inc. is a wholly owned 
subsidiary of Anokion.
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4.1.1. Part A: Phase 1b, Open-Label, Multiple Ascending Dose Study
Part A is a Phase 1b, open-label, MAD study design to assess the safety, tolerability and PK
of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed CeD. 
Up to 18 participants who meet study inclusion/exclusion criteria may be randomized in the 
study.
Part A comprises 3 periods: 

Screening period: Up to 28 days before the first dose

Treatment period: 7 days
o
Eligible participants will be administered IV study intervention on Day 1, Day 
4, and Day 7 (see Section 6.1.1).

Post infusion, participants will be monitored in the clinic for 4 hours 
for infusion-related reactions (see Appendix 9). 
o
The dose cohorts planned for Part A are:

1.2 mg/kg (Cohort 1)

3.0 mg/kg (Cohort 2)

Based on emerging data from previous and ongoing cohorts, doses 
planned may be repeated, modified and other doses may be explored in 
additional cohorts. If the exposures in the subsequent dose are
projected to exceed the exposure limits pre-specified, that dose will 
not be explored.

Observation/Follow-up period: 21 days
o
Post-dosing GC on Day 15: All participants administered KAN-101 will 
return to the clinic on Day 15 to receive a 1-day 9g oral GC to assess 
exploratory endpoints (plasma IL-2 biomarker response to gluten and collect 
symptom information).
o
Safety follow-up visit on Day 28: includes assessment of AEs, clinical signs 
and symptoms, and review of clinical laboratory values.
4.1.1.1. Part A Multiple Dose Escalation
All cohorts in Part A will employ inter-participant dosing whereby participants in each 
cohort will be dosed at least 14 days apart from the subsequent participants to monitor for the 
acute and subacute safety of KAN-101. 
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For Part A, a DSMB (see Section 10.1.5) will review cumulative safety data through the dose 
escalation safety review period (see Section 4.1.1.1.2) by cohort before opening a higher 
dose cohort. Initiation of the next dose cohort will commence once all participants in a cohort 
reach Day 15 prior to the GC, and upon acceptable safety review by DSMB and approval 
from sponsor.
Participants who withdraw from the study may be replaced at the discretion of the sponsor. A 
replacement subject will receive the same treatment as the withdrawn participant.
4.1.1.1.1. Dose-Limiting Toxicities (Part A Only)

Dose-limiting toxicity will be defined as any Grade 2 AE lasting longer than 14 days 
or any ≥ Grade 3 AE assessed as related to study intervention.

If a DLT is observed in Part A, the study will be paused and the DSMB will review 
the information prior to dosing additional participants. The cohort will be expanded to 
6 participants total before dose escalation is reviewed.

The NTD is the dose level at which 2 or more participants experience a DLT during 
the dose escalation safety review period. The MTD will be defined as the dose level 
immediately below the NTD. 
o
Of note, dose escalation may not identify an NTD or MTD.
o
If an MTD is identified in Part A, dose levels in Part B will not exceed the 
MTD.
DLTs DO NOT include:

AEs attributable solely to intercurrent illness or other concomitant medications.
Stopping rules in case of DLT are presented in Section 6.6.1.1.
4.1.1.1.2. Dose Escalation Safety Review Period (Part A Only)
In Part A, the dose escalation safety review period is from the beginning of IV administration 
through Day 15 prior to initiating the GC. 
Any AEs that meet the above criteria, but occur after the dose escalation safety review period 
of Part A may be considered by the DSMB in the evaluation for Part B dose selection.
Further details are presented in Section 6.6.1.
The dosing schedule requires that successively higher doses will only be administered after 
the safety, tolerability and available PK data of the preceding dose group has been evaluated 
by the DSMB and approved by the sponsor. Doses may be adjusted based on the PK and 
safety findings of the preceding dose group(s).
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4.1.2. Part B: Phase 2, Double-Blind, Placebo-Controlled Study
Part B is a Phase 2, double-blind, PBO-controlled, parallel design study to characterize the 
biomarker response (plasma IL-2; primary endpoint) in peripheral blood following GC,
Safety, tolerability, and PK of KAN-101 in adult participants (18 to 70 years of age
inclusive) with histology-confirmed CeD will also be analyzed. 16 participants 
(approximately 4 participants per dose group) will be randomized 1:1:1:1 and stratified by 
participation in biopsy substudy to the following treatment groups: 

PBO (Group 1)

0.6 mg/kg (Group 2)

1.2 mg/kg (Group 3)

3.0 mg/kg (Group 4)
Initiation of Part B will occur following the DSMB review of available safety and PK data 
from Part A and the sponsor’s approval. 
Part B comprises 4 periods and 1 sub-study:

Screening period: ≤ 28 days

Run-in period: 21 days 

Eligible participants will undergo a 1-day 9g GC on first day of run-in 
period (21 days before administration of first dose of study drug) to 
confirm symptomatic response to oral GC (see Section 8.2.1).

Non-responders (participants with asymptomatic response to GC) will be 
screen-failed from the study.

Symptomatic responders eligible to participate in the study will be 
randomized and will proceed to the Treatment period.

Treatment period: 7 days

Symptomatic responders to the run-in GC will be randomized 1:1:1:1 to one 
of the 4 Treatment groups and administered study intervention IV for 3 
administrations (1 administration every 3 days starting at Day 1).
Post infusion, participants will be monitored in the clinic for 4 hours for 
infusion-related reactions (see Appendix 9).
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
Observation/follow-up period: 358 days

Post-dosing GC on Day 15: All participants will return to the clinic on Day 
15 to receive a 1-day 9 g oral GC to assess plasma IL-2 biomarker response 
(primary endpoint) to gluten and collect symptom information.

Post-dosing GC at Weeks 12, 24, and 36: All participants will return to the 
clinic to receive a 1-day 9 g oral GC to assess plasma IL-2 biomarker response 
to gluten and collect symptom information (exploratory endpoints).

Follow-up visits: on Day 28 and Week 52.

Biopsy Substudy (applicable sites only)

Approximately 50% of Part B cohort participants at applicable sites will 
receive biopsies (see Section 8.2.4) at screening and Week 52 per the SoA.
Note: for participants in the biopsy sub-study the EGD with biopsy will be 
performed only once all eligibility criteria, except for Inclusion Criterion #5,
are fulfilled.
Note: For Part B, DSMB will review data periodically and make recommendations to the 
sponsor to continue the study as planned, modify the study, temporarily suspend or terminate 
the study.
4.1.3. Part C: Phase 2, Double-Blind, Placebo-Controlled Study
Part C is a Phase 2, double-blind, PBO-controlled, parallel design study to compare the 
biomarker response (plasma IL-2; primary endpoint) following GC on Day 15. Safety, 
tolerability, and PK of KAN-101 in adult participants (18 to 70 years of age inclusive) with 
histology-confirmed CeD will be assessed. Approximately 104 participants (approximately 
26 participants per dose group) will be randomized 1:1:1:1 and stratified by participation in 
biopsy substudy to the following treatment groups: 

PBO (Group 1)

0.6 mg/kg (Group 2)

1.2 mg/kg (Group 3)

3.0 mg/kg (Group 4)
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Initiation of Part C will occur following the DSMB review of available safety data from Part 
B and the sponsor’s approval. 
Additional safety data including orthostatic vital signs, temperature, RR and post-dose/GC 
safety labs will be collected in Part C as detailed below. 
Part C comprises 3 periods and 1 sub-study: 

Screening period: Day -28 to Day -1

Treatment period: Day 1 to Day 7

Participants will be randomized 1:1:1:1 to one of the 4 treatment groups and 
administered study intervention IV for 3 administrations (1 administration 
every 3 days starting at Day 1).

Orthostatic vital signs, temperature, and RR will be measured at times 
decribed in the SoA.
Follow-up period: Day after last dose till Day 364 (±3 days). Participants will be 
followed for additional approximately 358 days which will include:

Post-dosing GC on Day 15: All participants will return to the clinic on Day 
15 to receive a 1-day 9 g oral GC.

Post-dosing GC at Weeks 12, 24, and 36: All participants will return to the 
clinic to receive a 1-day 9 g oral GC.

Safety follow-up visits on Day 28 and Week 52: includes assessment of 
AEs, clinical signs and symptoms, and safety labs (Week 52 only).

Biopsy Substudy (applicable sites only)

Approximately 50% of participants in Part C (at applicable sites) will receive 
biopsies (see Section 8.2.4) at screening and Week 52 per the SoA. Note: for 
participants in the biopsy sub-study the EGD with biopsy will be performed 
only once all eligibility criteria are fulfilled.
Note: For Part C, DSMB will review data periodically and make recommendations to the 
sponsor to continue the study as planned, modify the study, temporarily suspend or terminate 
the study.
4.2. Scientific Rationale for Study Design
In KAN-101-01 study, participants treated with 0.15 mg/kg, 0.3 mg/kg and 0.6 mg/kg of 
KAN-101 exhibited T-cell tolerance to gliadin by demonstrating minimal change or a 
decrease in the gliadin-specific T-cell response to GC compared to participants in the placebo 
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who exhibited an increase in the gliadin-specific T-cell response following GC. In addition, 
participants treated with 0.6 mg/kg KAN-101 exhibited lower median interleukin-2 (IL-2) 
levels after GC compared to the IL-2 levels in Placebo or 0.15 mg/kg and 0.3 mg/kg KAN-
101 groups. Overall, KAN-101 demonstrated an acceptable safety and tolerability profile in 
both Part A and Part B of the study at all doses tested. There were no deaths, SAEs, Grade 3 
TEAEs, or DLTs observed; therefore, no MTD was determined in this study. With expected 
efficacy dose of 1.2 mg/kg or over, higher doses may be explored in future studies. Further 
details are provided in the KAN-101 IB.
In KAN-101-01 and non-clinical models, T-cell tolerance induction was observed as early as 
1 week after drug administration in celiac patients, supporting the timing of the primary 
endpoint assessment and the safety review period.
In the previous protocol for this study, 1.2 mg/kg, 3.0 mg/kg and 6.0 mg/kg KAN-101 were 
planned to be evaluated in a MAD 3+3 design (Part A).  Based upon emerging data from Part 
A, the protocol has been amended to proceed to Part B following completion of Part A 3.0 
mg/kg dose cohort. The decision not to test 6.0 mg/kg was not due to any safety concerns or 
exposures which exceeded the NOAEL. Part B evaluated 0.6 mg/kg, 1.2 mg/kg, and 3.0
mg/kg in a dose-ranging design (Part B) in CeD participants on GFD
Sixteen participants were randomized at which time, study was paused and ad-hoc DSMB
was convened to assess emerging safety data.
After review of emerging data by DSMB, Part B was closed due to concerns for sensitization 
by screening GC, potentially leading to higher frequency and severity of AEs observed after 
dosing with KAN-101/PBO. The study remains blinded.
In amendment 3 of this protocol, Part C is added. In Part C, the screening GC requirement is 
removed. As a result, the primary objective will now be evaluating the change in magnitude 
of IL-2 response before and after GC in KAN-101 treated versus placebo participants on Day 
15. Furthermore, in order to get more insight into the events immediately subsequent to 
dosing, additional assessments including orthostatic vital signs, temperature, and RR are 
collected. Additionally, safety labs (hematology and chemistry) will be collected in case of 
orthostatic hypotension, syncope, or TEAE, Grade 3 or greater.
4.2.1. Choice of Contraception/Barrier Requirements 
KAN-101 has not been evaluated in EFD study. The effects of KAN-101 on conception, 
pregnancy, and lactation are unknown. Therefore, the use of a highly effective contraception 
and a barrier method is required for WOCBP, and all men who are not sterile (biologically or 
surgically) must commit to the use of 1 reliable method of birth control for at least 21 days 
after the last dose of study intervention (see Appendix 4 for further information).
The observed t1/2 of KAN-101 from the FIH study ranges between 3.74 to 36.8 minutes 
across 0.15 mg/kg to 1.2 mg/kg doses with no accumulation observed for repeat dosing. Pre-
clinical toxicology and clinical information for KAN-101 are summarized in the IB.
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4.3. Justification for Dose
4.3.1. Exposure Limits for Dose Escalation
The measurement of KAN-101 exposure levels in GLP toxicology studies was impacted by 
sample processing of the serum samples and therefore is not being used to calculate the 
exposure and safety margins. To calculate the KAN-101 exposures and safety margins, the 
KAN0009 peptide, a component of KAN-101, was measured in GLP toxicology studies and 
converted to KAN-101 exposure using a factor that was empirically determined during assay 
development.
In this study, the KAN-101 Cmax and AUClast exposure limits for dose escalation are 
determined to be 346,969 ng/mL and 202,646 ng.hr/mL, respectively, based on the NOAEL 
(74 mg/kg) exposures in the cynomolgus monkey study.
4.3.2. Dose Justification for Part A and Part B and Part C
Based on KAN-101-01 study results, doses covering projected efficacious doses (0.6 mg/kg 
and over) will be evaluated in this Phase 1b open-label /Phase 2 double-blind placebo-
controlled study for pharmacodynamic activity, safety, and tolerability of KAN-101 in 
participants with celiac disease.
The proposed doses for Part A are 1.2 mg/kg, 3 mg/kg and 6 mg/kg administered in 3 doses 3 
days apart. Based upon emerging data from Part A, the protocol has been amended to 
proceed to Part B following completion of Part A 3.0 mg/kg dose cohort. The decision not to 
test 6.0 mg/kg was not due to any safety concerns or exposures which exceeded the NOAEL.
Single doses of 1.2 mg/kg tested in KAN-101-01 study were well-tolerated. Given the short 
t1/2 of KAN-101, minimal accumulation is expected after repeat dosing with similar safety 
and tolerability as single doses thus providing a bridge for a safe and tolerable starting dose 
proposed for this study.
Table 1 presents the predicted exposures and safety margins relative to the NOAEL 
exposures for the proposed doses in Part A. The predictions presented linearly extrapolate the
exposures observed at 1.2 mg/kg in KAN-101-01 study.
Table 1.
Projected Exposures and Safety Margins Following Repeat IV Doses of 
KAN-101
Dosea
(mg/kg)
Cmaxb
(ng/mL)
AUClastb
(ng.hr/mL)
SM_Cmaxc
(fold)
SM_AUClastc
(fold)
1.2 
19,470
13,920
17.8
14.6
3 
48,675
34,800
7.1
5.8
a.
Represents a dosing frequency of every 3 days for 3 doses.
b.
Cmax, and AUClast values after the third IV dose are presented in the table.
c.
SM is calculated relative the cynomolgus monkey NOAEL exposures (Cmax= 346,969 ng/mL and AUClast= 202,646
ng.hr/mL)
The predicted KAN-101 Cmax and AUClast at starting dose of KAN-101 1.2 mg/kg are 
approximately 17.8 and 14.6 fold below the pre-defined exposure limits (Table 1).The 
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highest proposed dose in Part A of 6 mg/kg IV Q3 days is estimated to provide an exposure 
margin of 3.6- and 2.9-fold for Cmax and AUClast, respectively.
This frequency of dosing in the study is supported by the nonclinical experimental EAE 
mouse model that demonstrated that dosing every 3 days was more effective than weekly 
dosing as well as by the clinical efficacy biomarker data from the FIH study.
In Part B and Part C, KAN-101 will be be tested at 3 dose levels of 0.6 mg/kg, 1.2 mg/kg and 
3.0 mg/kg or placebo administered in 3 doses 3 days apart. 
In Part A, doses planned may be repeated, modified and other doses may be explored in 
additional cohorts or groups based on emerging data from previous and ongoing cohorts. If 
the exposures in the subsequent dose are projected to exceed the exposure limits pre-
specified, that dose will not be explored.
4.4. End of Study Definition
The end of the study is defined as the date of the last visit of the last participant in the study 
or last scheduled procedure shown in the SoA for the last participant in the trial globally.
A participant is considered to have completed the study if they have completed all periods of 
the study, including the last visit or the last scheduled procedure shown in the SoA.
5. STUDY POPULATION
This study can fulfill its objectives only if appropriate participants are enrolled, including 
participants across diverse and representative racial and ethnic backgrounds. If a 
prescreening tool is utilized for study recruitment purposes, it will include collection of 
information that reflects the enrollment of a diverse participant population including, where 
permitted under local regulations, age, sex, race, and ethnicity. The following eligibility 
criteria are designed to select participants for whom participation in the study is considered 
appropriate. All relevant medical and nonmedical conditions should be taken into
consideration when deciding whether a particular participant is suitable for this protocol.
Prospective approval of protocol deviations to recruitment and enrollment criteria, also 
known as protocol waivers or exemptions, is not permitted.
For Part A and Part C: All inclusion/exclusion criteria must be met and confirmed prior to 
randomization.
For Part B: all inclusion criteria (Section 5.1), except Inclusion Criterion #5, and all
exclusion criteria (Section 5.2) must be met and confirmed prior to entry into the run-in 
period and run-in GC assessment at Day -21. All inclusion/exclusion criteria must be met and 
confirmed prior to randomization.
For Part B Biopsy Substudy: all inclusion criteria (Section 5.1), except Inclusion 
Criterion #5, and all exclusion criteria (Section 5.2) must be met and confirmed prior to 
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undergoing the screening biopsy. All inclusion/exclusion criteria must be met and confirmed 
prior to randomization.
For Part C Biopsy Substudy: all inclusion criteria (Section 5.1), and all exclusion criteria 
(Section 5.2) must be met and confirmed prior to undergoing the screening biopsy. All
inclusion/exclusion criteria must be met and confirmed prior to randomization.
5.1. Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Age and Sex:
1. Participants aged 18 years to 70 inclusive (or the minimum age of consent in 
accordance with local regulations) at screening.

Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and 
female (Section 10.4.2) participants.
Disease Characteristics:
2. Previous diagnosis of CeD, based on documentation in the source data:

Positive celiac serology (eg, tissue transglutaminase IgA antibody and/or 
deamidated DGP IgG)
AND

Intestinal histology consistent with ≥ Marsh Type 2 (Section 10.11) or with 
evidence of villous atrophy.
3. Have HLA-DQ2.5 genotype (HLA-DQA1*05 and HLA-DQB1*02 (homozygotes or 
heterozygotes)).
4. Negative or weak positive for transglutaminase IgA AND negative or weak positive 
for DGP-IgA/IgG during screening.

For tTG, a result of ≤10 U/mL will be considered negative or weak positive. 

For DGP, a result of <30 U/mL will be considered negative or weak positive.
5. Part B ONLY (prior to randomization): Demonstrates a symptomatic response
following a 1-day oral GC performed during Run-in, defined as having at least 
1 moderate to severe GI symptom (either diarrhea, abdominal pain, bloating, or 
nausea) the day of the GC.

Refer to Section 8.2.1.1 for symptomatic response criteria.
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Other Inclusion Criteria:
6. Have followed a gluten-free diet for ≥12 months immediately prior to study entry
(self-reported).
7. Capable of understanding the ICD, complying with protocol requirements, and has 
signed the ICD.
5.2. Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions:
1. Refractory CeD, defined as severe persistent or recurrent malabsorptive signs or 
symptoms with substantial villous atrophy (ex. documented Marsh score 3c in source 
data) despite strict adherence to a GFD for at least 12 months in the absence of other 
disorders.
2. Selective IgA deficiency.
3. Positive for HLA-DQ8 (DQA1*03, DQB1*0302).
4. Known wheat allergy.
5. Known history of severe hypersensitivity reactions or anaphylaxis to gluten.
6. Previous oral GC within 12 months.
7. History of dermatitis herpetiformis.
8. Active gastrointestinal disease (eg, inflammatory bowel disease, any forms of colitis, 
uncontrolled IBS, peptic ulcer disease, eosinophilic esophagitis, and active GI 
infections).
9. Diagnosis of Type-I diabetes.
10. Clinical signs and symptoms consistent with COVID-19 or confirmed infection by 
appropriate laboratory test within the 2 weeks prior to screening or dosing.
Note: participants who experienced symptoms consistent with COVID-19 or 
confirmed infection during the screening period may be rescreened after 4 
weeks. 
11. Prior severe course of COVID-19 requiring extracorporeal membrane oxygenation or 
mechanical ventilation within the last 12 months.
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12. Other uncontrolled or significant medical (including active infections) or psychiatric 
condition including recent (within the past year) or active suicidal ideation/behavior 
or laboratory abnormality that may increase the risk of study participation or, in the 
investigator’s judgment, make the participant inappropriate for the study.
Prior/Concomitant Therapy:
13. Previous treatment with tolerance-inducing therapies for CeD.
14. Current use of any prohibited concomitant medication(s) or participants
unwilling/unable to use a permitted concomitant medication(s). Refer to Section 6.9
Prior and Concomitant Therapy. 
Prior/Concurrent Clinical Study Experience:
15. Previous administration with an investigational product (drug or vaccine) within 
30 days (or as determined by the local requirement) or 5 half-lives preceding the first 
dose of study intervention used in this study (whichever is longer). 
Diagnostic Assessments:
16. Renal impairment as defined by an eGFR in adults of <60 mL/min/1.73m2. Based 
upon participant age at screening, eGFR is calculated using the recommended 
formulas in Section 10.7.2 to determine eligibility and to provide a baseline to 
quantify any subsequent kidney safety events. 
17. Hepatic dysfunction defined as:

Total bilirubin ≥1.5 × ULN (except for Gilbert’s syndrome)

AST ≥1.5 × ULN

ALT ≥1.5 × ULN

Alkaline phosphatase > 1.5 × ULN
18. Hematologic abnormalities defined as:

ANC ≤1000 mm3

Platelets ≤100 × 109/L 

Hemoglobin ≤10 g/dL

WBC outside the normal range and assessed as clinically significant by the 
investigator.
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19. Positive for HIV, hepatitis B, and/or hepatitis C.

For Hepatitis B, all participants will undergo testing for HBsAg and HBcAb 
during screening. Participants who are HBsAg positive are not eligible for the 
study. Participants who are HBsAg negative and HBcAb positive will be 
reflex tested for HBsAb and HBV DNA. If HBsAb is positive and HBV DNA 
negative, they may be enrolled in the study; if HBsAb is negative and/or HBV 
DNA is positive, the participant is not eligible for the study.

For Hepatitis C, all participants will undergo HCVAb during screening. 
Participants with positive HCVAb tests will be reflex tested for HCV RNA. 
Only participants with negative HCVAb or HCV RNA will be allowed to 
enroll. 

For HIV, known history of HIV based on documented history with positive 
serological test, or positive HIV serologic test at screening, tested at central 
lab.
20. Baseline standard 12-lead ECG that demonstrates clinically relevant abnormalities 
that may affect participant safety or interpretation of study results (eg, QTcF
>450 ms, complete LBBB, signs of an acute or indeterminate-age myocardial 
infarction, ST-T interval changes suggestive of myocardial ischemia, second- or 
third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias).

If the baseline uncorrected QT interval is >450 ms, this interval should be rate 
corrected using the Fridericia method only and the resulting QTcF should be 
used for decision making and reporting. 

If QTcF exceeds 450 ms, or QRS exceeds 120 ms, the ECG should be 
repeated twice and the average of the 3 QTcF or QRS values used to 
determine the participant’s eligibility. 

Computer-interpreted ECGs should be overread by a physician experienced in 
reading ECGs before excluding a participant.
Other Exclusion Criteria:
21. Investigator site staff directly involved in the conduct of the study and their family 
members, site staff otherwise supervised by the investigator, and sponsor and 
sponsor delegate employees directly involved in the conduct of the study and their 
family members.
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5.3. Lifestyle Considerations
The following guidelines are provided:
5.3.1. Contraception 
The investigator or their designee, in consultation with the participant, will confirm that the 
participant is utilizing an appropriate method of contraception for the individual participant 
and their partner(s) from the permitted list of contraception methods (see Appendix 4,
Section 10.4.4) and will confirm that the participant has been instructed in its consistent and 
correct use. At time points indicated in the SoA, the investigator or designee will inform the 
participant of the need to use highly effective contraception consistently and correctly and 
document the conversation and the participant’s affirmation in the participant’s chart.
Participants need to affirm their consistent and correct use of the selected methods of 
contraception, considering that their risk for pregnancy may have changed since the last visit. 
In addition, the investigator or designee will instruct the participant to call immediately if the 
selected contraception method is discontinued and document the requirement to use an 
alternate protocol-specified method, including if the participant will no longer use abstinence 
as the selected contraception method, or if pregnancy is known or suspected in the participant 
or partner.
5.3.2. Meals and Dietary Restrictions 
Following a GFD for at least 12 months is required for study entry (see Section 5.1).
Participants are required to continue to follow a GFD during the study; incidental gluten 
exposure will be collected daily as part of an eDiary and reviewed at every study visit (see 
Section 8.3.1).
Participant’s use of herbal medicines and probiotics should be reported on the CRF and 
should remain stable during the study.
5.3.3. Caffeine, Alcohol, and Tobacco
Participants should avoid excessive consumption of alcohol prior to visits with safety lab 
assessments as specified in the SoA.
5.3.4. Activity 
Participants should avoid strenuous physical activities prior to visits with safety lab 
assessments as specified in the SoA.
5.4. Screen Failures
Screen failures are defined as participants who consent to participate in the clinical study but 
are not subsequently randomized in the study. For participants who are screen failed (prior to 
the run-in GC, Part B only), a minimal set of screen failure information, including 
demography, screen failure details, eligibility criteria, and any AE or SAE, are required to be 
collected on the CRF. Screen failure data for participants who are failed (after the run-in GC, 
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Part B only) will be reported on the CRF. CRF reported data will include, but is not limited 
to, demographics, medical/CeD history, and prior CeD treatments. Participants who screen-
fail (after the run-in GC, Part B only) will also have non-CRF-reported data collected, 
including, but, not limited to, HLA, CeD serology, biopsy results, CDSD v2.1 data collected 
up to date of screen failure, and GC IL-2 biomarker data. Non-CRF reported data will be 
transferred to the sponsor, or sponsor’s designee (Pfizer).
Individuals who do not meet the criteria (prior to run-in GC, Part B only) for participation in 
this study (screen failure) may be rescreened. 
Individuals in Part A and Part C who do not meet the criteria for participation in this study 
(screen failure) may be rescreened EXCEPT as noted below.
Repeating HLA genotyping is not needed during rescreening period. Repeating celiac 
serology and/or EGD with biopsy (for participants in the biopsy substudy) is not required 
during rescreening if it is within 3 months of the initial assessments during the first screening 
period.
Participants cannot be rescreened if they fail screening due to: 

HLA genotyping assessment at screening.

Positive for HIV, HBV, or HCV.
For Part B only: 

Individuals who complete the run-in GC, are symptomatic, but are not 
randomized are eligible for re-screening after 12 months have elapsed.

Participants cannot be rescreened if they fail screening due to:

Reasons listed above.

Asymptomatic response to the run-in gluten challenge (Section 8.2.1.1).
6. STUDY INTERVENTION(S) AND CONCOMITANT THERAPY
Study interventions are all prespecified investigational and noninvestigational medicinal 
products/auxiliary medicinal products, medical devices, and other interventions (eg, surgical 
and behavioral) intended to be administered to the study participants during the study 
conduct.
For the purposes of this protocol, study intervention refers to KAN-101 or PBO for 
KAN-101.
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6.1. Study Intervention(s) Administered
Study Intervention(s)
Intervention Name
KAN-101
PBO
Arm Name
(group of participants receiving 
a specific treatment or no 
treatment)
Part A: Cohort 1 and 2
Part B: Group 2, 3, and 4
Part C: Group 2, 3, and 4
Part A: N/A
Part B: Group 1
Part C: Group 1
Type
Drug
PBO
Dose Formulation
Solution in a single-use glass vial 
for dilution into saline bag for IV 
infusion
Solution for infusion in a saline 
bag
Unit Dose Strength(s)
 
 
 
N/A
Dosage Level(s)
PBO
Route of Administration
IV
IV
Use
Experimental
Placebo
IMP or NIMP/AxMP
IMP
Placebo
Sourcing
Provided centrally by the sponsor.
Further details are presented in the 
IPM.
Provided locally by the site.
Further details are presented in the 
IPM.
Packaging and Labeling
Study intervention will be 
provided in glass vials. Each vial
will be labeled as required per 
country requirement.
In Part B and Part C, study 
intervention will be blinded once 
diluted in a saline bag.
Study intervention will be 
provided in saline bags. Each 
saline bag will be labeled as 
required per country requirement.
In Part B and Part C, study 
intervention will be blinded.
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Study Arm(s)
Part A (open-label)
Arm Title
Cohort 1
Cohort 2
Arm Type
Experimental
Experimental
Arm Description
Participants will receive 1.2 mg/kg IV 
every 3 days starting on Day 1 and 
ending on Day 7.
Participants will receive 3.0 mg/kg IV 
every 3 days starting on Day 1 and 
ending on Day 7.
Associated Intervention 
Labels
KAN-101
KAN-101
Part B and Part C (double-blind)
Arm Title
Group 1
Group 2
Group 3
Group 4
Arm Type
Placebo
Experimental
Experimental
Experimental
Arm Description
Participants will 
receive PBO IV 
every 3 days 
starting on Day 1 
and ending on 
Day 7.
Participants will 
receive 0.6 mg/kg 
IV every 3 days 
starting on Day 1 
and ending on 
Day 7.
Participants will 
receive 1.2 mg/kg 
IV every 3 days 
starting on Day 1 
and ending on 
Day 7. 
Participants will 
receive 3.0 mg/kg 
IV every 3 days 
starting on Day 1 
and ending on 
Day 7. 
Associated Intervention 
Labels
PBO
KAN-101
KAN-101
KAN-101
6.1.1. Administration
Administration of KAN-101 will be by IV infusion over approximately 30 minutes for the 
following dosages: 0.6 mg/kg, 1.2 mg/kg, or 3.0 mg/kg mixed with saline to have the final 
250 mL IV infusion solution.
PBO will be 250 mL normal saline only. Administration of PBO will be by IV infusion over 
approximately 30 minutes. 
In Part B and Part C only, for participants who may have experienced adverse events
following previous study intervention administration, prophylactic medication such as 
ondansetron may be administered 30 minutes before subsequent study intervention
administration at the discretion of the investigator.
6.2. Preparation, Handling, Storage, and Accountability
1. The investigator or designee must confirm that appropriate conditions (eg, 
temperature) have been maintained during transit for all study interventions received 
and any discrepancies are reported and resolved before use of the study intervention. 
2. Only participants enrolled in the study may receive study intervention and only 
authorized site staff may supply, prepare, and/or administer study intervention. 
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3. All study interventions must be stored in a secure, environmentally controlled, and 
monitored (manual or automated recording) area in accordance with the labeled 
storage conditions with access limited to the investigator and authorized site staff. At 
a minimum, daily minimum and maximum temperatures for all site storage locations 
must be documented and available upon request. Data for nonworking days must 
indicate the minimum and maximum temperatures since previously documented upon 
return to business.
4. Any excursions from the study intervention label storage conditions should be 
reported to Pfizer upon discovery along with actions taken. The site should actively 
pursue options for returning the study intervention to labeled storage conditions, as 
soon as possible. Once an excursion is identified, the study intervention must be 
quarantined and not used until Pfizer provides permission to use the study 
intervention. Specific details regarding the excursion definition and information to
report for each excursion will be provided to the site in the IPM or other specified 
location.
5. Any storage conditions stated in the SRSD will be superseded by the storage 
conditions stated on the label. See the IPM for storage conditions of the study 
intervention once diluted.
6. Study interventions should be stored in their original containers.
7. The investigator, institution, head of the medical institution (where applicable), or 
authorized site staff is responsible for study intervention accountability, 
reconciliation, and record maintenance (ie, receipt, reconciliation, and final 
disposition records), such as the IPAL or sponsor-approved equivalent. All study 
interventions will be accounted for using a study intervention accountability 
form/record. 
8. Further guidance and information for the final disposition of unused study 
interventions are provided in the IPM. All destruction must be adequately 
documented. If destruction is authorized to take place at the investigator site, the 
investigator must ensure that the materials are destroyed in compliance with 
applicable environmental regulations, institutional policy, and any special instructions 
provided by Pfizer.
Upon identification of a product complaint, notify Pfizer within 1 business day of discovery
as described in the IPM.
6.2.1. Preparation and Dispensing
See the IPM for instructions on how to prepare the study intervention for administration. 
Study intervention should be prepared and dispensed by an appropriately qualified and 
experienced member of the study staff (eg, physician, nurse, physician’s assistant, nurse 
practitioner, pharmacy assistant/technician, or pharmacist) as allowed by local, state, and 
institutional guidance. A second staff member will verify the dispensing.
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6.3. Assignment to Study Intervention
Allocation of participants to treatment groups will proceed through the use of an IRT system. 
The site personnel (ex. study coordinator or specified designee) will be required to enter or 
select information including but not limited to the user’s ID and password, the protocol 
number, and the participant number. The site personnel will then be provided with a 
randomization number corresponding to the assigned treatment group, and DU or container 
number(s) when study intervention is being supplied via the IRT system. The IRT system 
will provide a confirmation report containing the participant number, randomization number, 
and DU or container number assigned. The confirmation report must be stored in the site’s 
files. 
Part A is an open-label study. The investigator’s knowledge of the treatment assignment must 
not influence the decision to enroll a particular participant or affect the order in which 
participants are enrolled. Potential bias will be reduced by the following steps: central 
randomization and DSMB review.
Study intervention will be dispensed at the study visits summarized in the SoA. 
The study-specific IRT reference manual and IPM will provide the contact information and 
further details on the use of the IRT system.
6.4. Blinding
This is a 3 part study; Part A is open-label and Part B and Part C are double-blinded . 
6.4.1. Blinding of Participants

Part A is open-label.

In Part B and Part C, participants and their caregivers will be blinded to their 
assigned study intervention.
6.4.2. Blinding of Site Personnel

Part A is open-label. 

In Part B and Part C, investigators and other site staff will be blinded to 
participants’ assigned study intervention. Participants will be assigned to receive 
study intervention according to the assigned treatment group from the 
randomization scheme. Investigators will remain blinded to each participant’s 
assigned study intervention throughout the course of the study.
Unblinded personnel include site staff involved in study intervention preparation and 
allocation (eg, data systems support and pharmacists).
6.4.3. Blinding of the Sponsor

Part A is open-label. The data for dose escalation in Part A will be presented and 
reviewed by the DSMB in an open-label, unblinded manner. 
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
For Part B and Part C, sponsor staff will be blinded to participants’ assigned 
study intervention, except for sponsor staff involved in the assignment or 
distribution of study intervention. Sponsor staff who are not directly involved 
with the conduct of this study will prepare analyses and documentation containing 
unblinded data while the study is ongoing to support interactions with the DSMB.
6.4.4. Breaking the Blind
The IRT will be programmed with blind-breaking instructions. In case of an emergency, the 
investigator has the sole responsibility for determining if unblinding of a participant’s 
treatment assignment is warranted. Participant safety must always be the first consideration 
in making such a determination. If the investigator decides that unblinding is warranted, the 
investigator should make every effort to contact the study medical monitor prior to 
unblinding a participant’s treatment assignment unless this could delay further management 
of the participant. If a participant’s treatment assignment is unblinded, Pfizer must be 
notified within 24 hours after breaking the blind. The date and reason that the blind was 
broken must be recorded in the source documentation and CRF.
The study--specific IRT reference manual and IPM will provide the contact information and 
further details on the use of the IRT system.
6.5. Study Intervention Compliance
The existing clinical site's documentation system should capture all pertinent/required 
information on the preparation and administration of the dose. 
Compliance with the study intervention is defined as receiving 100% of the doses as 
specified per protocol. 
6.6. Dose Modification
In Part B and Part C, no dose modification is allowed following selection of doses based 
on safety and tolerability of doses studied in Part A.
In Part A, the decision to proceed to the next dose level of KAN-101 (either an increase or a 
decrease) will be made by the study team and DSMB during the dose escalation safety period 
(see Section 6.6.1). 
Details of the DSMB are presented in Section 10.1.5.
If the decision is made to dose escalate, it is the sponsor’s discretion whether to proceed with 
escalation, expand the same dose cohort, or to modify doses based on emerging data.
6.6.1. Dose Escalation Safety Review Period for Part A
In Part A, the dose escalation safety review period is from the beginning of IV administration 
through Day 15 prior to GC. Any AEs that meet DLT criteria (Section 4.1.1.1.1) but occur 
after the dose escalation safety monitoring period of Part A may be considered by the 
DSMB/Sponsor in the evaluation of Part A dose escalation and Part B dose selection.
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The length of monitoring periods for safety review is supported by nonclinical exposure data 
and FIH clinical data, suggesting KAN-101 will have cleared 5 half-lives, and clinical data 
demonstrating that the tolerance induction mechanism can develop within 1 week of dosing. 
Participants will be monitored in the clinic for 4 hours following the IV administration of 
study intervention.
AEs and any abnormal clinical parameters, including laboratory findings and available PK
data, observed during this period will be used by the DSMB to determine whether dose 
escalation should proceed. DSMB review of ongoing safety data will continue after dose 
escalation has either been completed or stopped and participants remain active in the study. 
Dose escalation in Part A can proceed after the following criteria are met:

All 3 participants have been dosed.

DSMB, sponsor medical monitor and investigators who enrolled participants have 
reviewed all available safety data for dosed subjects, including:

A minimum of 1 week safety and tolerability data after the last study intervention 
dose; 
AND

All available PK data after the last study intervention dose.
6.6.1.1. Individual and Cohort Stopping Rules
Dose escalation stopping rules will be used to determine whether the MTD has been attained. 
Dose escalation will be stopped if it is determined that the limits of safety and/or tolerability 
have been reached based on the criteria described in this section. This decision will be made 
after a discussion takes place between the DSMB, the sponsor study team and the 
investigator. The sponsor study team may not overrule the DSMB or investigator’s decision 
to stop dose escalation. If dose escalation is stopped because of any of these criteria, 
additional cohorts may receive the same or lower doses of the study intervention. If any dose 
cohort is repeated, this additional cohort will be considered a separate cohort for the purpose 
of these dose escalation stopping rules.
For DLT definition for Part A and further details, see Section 4.1.1.1.1.
At any time:

Any TEAE at Grade 3 or higher experienced during the study will be reviewed by 
DSMB.
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
Any ≥Grade 4 AE will result in notification of the FDA in parallel with DSMB and 
study dosing and enrollment will be paused pending review by FDA. 

The study would only continue after consultation with the FDA. 

No participant with a DLT will be replaced.
In Part A: 

If a participant experiences a DLT, no additional doses will be administered to that 
participant.

If 1 of the first 3 participants experiences a DLT in a given cohort, 3 additional 
participants will be enrolled and evaluated in that cohort before dose escalation can 
occur if recommended by the DSMB and only after consultation with the FDA for 
any ≥Grade 4 AE. 

If 2 or more participants experience a DLT at a given dose during the dose escalation 
period of Part A, then that dose level will be considered a NTD and no further 
escalation will proceed.
In Part B and Part C:

DSMB will review unblinded available clinical, laboratory and PK data (if available)
periodically or if there is a Grade 3 or above, related AE during treatment period and 
will make recommendations for study continuation as defined in the DSMB charter. 
6.7. Continued Access to Study Intervention After the End of the Study
No study intervention will be provided to participants at the end of their study participation.
It is expected that participants will be treated as required with standard-of-care treatments, as 
advised by their usual care physician.
6.8. Treatment of Overdose
For this study, any dose of study intervention greater than the maximum dose of study 
intervention according to the protocol within a 24-hour time period will be considered an 
overdose.
There is no specific treatment for an overdose.
In the event of an overdose, the investigator/treating physician should:
1. Contact the study medical monitor within 24 hours.
2. Closely monitor the participant for any AEs/SAEs and laboratory abnormalities as 
medically appropriate and at least until the next scheduled follow-up.
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3. Document the quantity of the excess dose as well as the duration of the overdose in 
the CRF.
4. Overdose is reportable to the sponsor only when associated with an SAE.
5. Obtain a blood sample for PK analysis as soon as overdose is identified but no later 
than 24 hours from the last over-dosed study intervention if requested by the study 
medical monitor (determined on a case-by-case basis). 
Decisions regarding dose interruptions or modifications will be made by the investigator in 
consultation with the study medical monitor as needed based on the clinical evaluation of the 
participant.
6.9. Prior and Concomitant Therapy
All participants are required to maintain stable dosing of permitted prescribed and OTC 
medications for the duration of the study. 
6.9.1. Prohibited During the Study
The following therapies are prohibited during the study:

Any additional therapies to treat CeD.

Other investigational agents, including biologic or non-biologic immunosuppressive 
or immunomodulatory therapies.

Non-investigational systemic immunosuppressive and immunomodulatory therapies 
(eg, systemic corticosteroids).

All vaccines between 4 weeks prior to dosing through 4 weeks from the last dose of 
study intervention; vaccines are permitted at all other times during the study. 
6.9.2. Permitted During the Study
Hormonal contraceptives that meet the requirements of this study are allowed to be used in 
participants who are WOCBP (see Appendix 4).
HRT use by postmenopausal women is permitted if they meet requirements in Appendix 4.
Any other medication that is considered necessary for the participant’s welfare that is not 
expected to interfere with the evaluation of KAN-101 may be given at the discretion of the 
investigator and documented on the CRF.
In cases involving concomitant therapies whose predicted interference with KAN-101 is 
unknown to the investigator, the sponsor should be contacted for discussion. 
Any medication (including over the counter or prescription medications, vitamins, and/or 
herbal supplements) that the patient receives after enrollment through the last study visit 
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must be recorded on the CRF. Participants should report any changes to permitted 
medications during the study to the investigator as soon as they occur. Medication changes 
must be documented in the participant’s record and CRF.
Patients being treated for IBS symptomology will be allowed to continue therapy (eg, 
dicyclomine) unless the drug is specifically prohibited.
Antidiarrheal (eg loperamide) or antiemetics (eg metoclopramide or ondansetron) may be 
used for IBS symptomatic treatment if warranted by symptomology unless the drug is 
specifically prohibited. If given at a study visit, use must be recorded on the CRF. 
6.9.3. Rescue Medicine 
There is no rescue therapy to reverse AEs observed with KAN-101; standard medical 
supportive care, (such as ondansetron) may be provided to manage AEs.
Medication such as Ondansetron is:
Part A: allowed in as symptomatic treatment,
Part B and Part C: allowed as symptomatic treatment of an AE after study drug 
intervention; and optionally allowed as pre-treatment to subsequent study intervention 
administration at investigator discretion based on the occurrence of AEs after previous study 
drug administration.
7. DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL
7.1. Discontinuation of Study Intervention
It may be necessary for a participant to permanently discontinue study intervention. Reasons 
for permanent discontinuation of study intervention include the following:

An AE that requires permanent discontinuation of study treatment*;

Noncompliance with the protocol;

Investigator decision;

Participant becomes pregnant;

Participant death;

Participant lost to follow-up;

Termination of the study by the sponsor;
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
Voluntary withdrawal of consent by the participant.
* Note: AEs leading to the discontinuation of study intervention will be followed until 
resolution, resolution to baseline, or the event is considered stable or chronic.
Note that discontinuation of study intervention does not represent withdrawal from the study.
If study intervention is permanently discontinued, the participant should remain in the study 
to be evaluated for safety. See the SoA for data to be collected at the time of discontinuation 
of study intervention and follow-up for any further evaluations that need to be completed.
In the event of discontinuation of study intervention, it must be documented on the 
appropriate CRF/in the medical records whether the participant is discontinuing further 
receipt of study intervention or also from study procedures, posttreatment study follow-up, 
and/or future collection of additional information.
Participants who withdraw from treatment and do not receive 3 full doses should not receive 
the GC or have plasma samples taken for IL-2 on GC days. 
7.1.1. Liver Injury
A participant who meets the criteria as described in Appendix 6 will be withdrawn from 
study intervention.
7.1.2. Pregnancy 
Pregnancy tests are conducted as specified per the SoA and administration of study 
intervention or GC will occur only in the presence of a negative pregnancy test.
If a participant is confirmed to be pregnant (see Section 8.3.6) during any visit, conducting of 
GCs and further dosing with study intervention will be discontinued immediately and 
permanently. 
Section 8.4.5.1 describes the follow-up activities if a participant meets EDP criteria. 
7.1.3. COVID-19 
If a participant has COVID-19 during the study, this should be reported as an AE or SAE (as 
appropriate) and appropriate medical intervention provided. 
It is recommended that the investigator discuss temporary or permanent discontinuation of 
study intervention with the study medical monitor. 
7.1.4. Temporary Discontinuation
In cases where a temporary discontinuation or dosing interruption is required, the total 
infusion should be completed within 6 hours of thawing the drug product. Any temporary 
discontinuations or interruptions of study intervention should be documented in the CRF. 
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See Appendix 9 for detailed guidance regarding infusion administration interruptions due to
IRR.
7.2. Participant Discontinuation/Withdrawal From the Study
A participant may withdraw from the study at any time at their own request. Reasons for 
discontinuation from the study include the following:

Investigator’s decision;

Participant death;

Participant lost to follow-up;

Termination of the study by Sponsor;

Voluntary withdrawal of consent of participant.
At the time of discontinuing from the study, if possible, an early discontinuation visit should 
be conducted. See the SoA for assessments to be collected at the time of study 
discontinuation and follow-up and for any further evaluations that need to be completed.
The participant will be permanently discontinued from the study intervention and the study at 
that time.
If a participant withdraws from the study, they may request destruction of any remaining 
samples taken and not tested, and the investigator must document any such requests in the 
site study records and notify the sponsor accordingly.
If the participant withdraws from the study and also withdraws consent (see Section 7.2.1) 
for disclosure of future information, no further evaluations will be performed and no 
additional data will be collected. The sponsor may retain and continue to use any data 
collected before such withdrawal of consent.
7.2.1. Withdrawal of Consent 
Participants who request to discontinue receipt of study intervention will remain in the study 
and must continue to be followed for protocol -specified follow-up procedures. The only 
exception to this is when a participant specifically withdraws consent for any further contact 
with them or persons previously authorized by the participant to provide this information. 
Participants should notify the investigator in writing of the decision to withdraw consent 
from future follow-up, whenever possible. The withdrawal of consent should be explained in 
detail in the medical records by the investigator, as to whether the withdrawal is only from 
further receipt of study intervention or also from study procedures and/or posttreatment study 
follow-up, and entered on the appropriate CRF page. In the event that vital status (whether 
the participant is alive or dead) is being measured, publicly available information should be 
used to determine vital status only as appropriately directed in accordance with local law.
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7.3. Lost to Follow-Up 
A participant will be considered lost to follow-up if the participant repeatedly fails to return 
for scheduled visits and is unable to be contacted by the study site.
The following actions must be taken if a participant fails to return to the clinic for a required 
study visit:

The site must attempt to contact the participant and reschedule the missed visit as
soon as possible. Counsel the participant on the importance of maintaining the 
assigned visit schedule, and ascertain whether the participant wishes to and/or should 
continue in the study;

Before a participant is deemed lost to follow-up, the investigator or designee must 
make every effort to regain contact with the participant (where possible, 3 telephone 
calls and, if necessary, a certified letter to the participant’s last known mailing 
address or local equivalent methods). These contact attempts should be documented 
in the participant’s medical record;

Should the participant continue to be unreachable, the participant will be considered 
to have withdrawn from the study. 
8. STUDY ASSESSMENTS AND PROCEDURES
8.1. Administrative Procedures
The investigator (or an appropriate delegate at the investigator site) must obtain a signed and 
dated ICD before performing any study-specific procedures.
Study procedures and their timing are summarized in the SoA. Protocol waivers or 
exemptions are not allowed.
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct.
All screening evaluations must be completed and reviewed to confirm that potential 
participants meet all eligibility criteria. The investigator will maintain a screening log to 
record details of all participants screened and to confirm eligibility or record reasons for 
screening failure, as applicable.
Every effort should be made to ensure that protocol -required tests and procedures are 
completed as described. However, it is anticipated that from time to time there may be 
circumstances outside the control of the investigator that make it unfeasible to perform the 
test. In these cases, the investigator must take all steps necessary to ensure the safety and 
well-being of the participant. When a protocol -required test cannot be performed, the 
investigator will document the reason for the missed test and any corrective and preventive 
actions that they have taken to ensure that required processes are adhered to as soon as 
possible. The study team must be informed of these incidents in a timely manner.
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For samples being collected and shipped, detailed collection, processing, storage, and 
shipment instructions and contact information will be provided to the investigator site prior 
to initiation of the study.
The total blood sampling volume for individual participants in this study is approximately 
225 mL in Part A, 150 mL in Part B, and 190 mL in Part C. The actual collection times of
blood sampling may change. Additional blood samples may be taken for safety assessments 
at times specified by the sponsor, provided the total volume taken during the study does not 
exceed 550 mL during the study.
8.2. Efficacy Assessments
Efficacy assessments are not performed. PD activity is being measured at times specified in 
the SoA.
8.2.1. Gluten Challenge
Participants are required to fast for at least 8 hours, except for water and any medications 
they might have previously been prescribed, prior to the study visits where GC are performed 
(see SoA). 

Part A: All eligible, enrolled participants will undergo GC at Day 15.

Part B: All eligible, enrolled participants will undergo 1-day GC during run-in and 
at times as specified in the SoA.

Part C: All eligible, enrolled participants will undergo 1-day GC at times as 
specified in the SoA.
In Part B, during run-in period: all participants must meet all inclusion criteria before 
commencement of GC except Inclusion Criterion #5.
A qualified staff member will prepare the GC in bottles at times specified in the SoA. 
Participants will consume 9g of gluten protein PO in the clinic and avoid foods (only water is 
permitted) at least 30 minutes after completion of the gluten drink. The participant will be 
observed for at least 4 hours to monitor for hyperacute reactions requiring medical treatment 
and collection of biomarker samples. 
Compliance with the GC is defined as completion of the entirety of the 9g GC, including 
container wash steps, within approximately 15 minutes. Participants will consume the GC on 
site under the observation of site staff.
Any symptoms associated with the GC should be recorded as AEs (See Section 8.4). Any 
AEs associated with the GC study assessment are separate to AEs related to study 
intervention (KAN-101/PBO). 
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8.2.1.1. Confirmation of Symptomatic Response to Run-in GC (Part B Only)
For Inclusion Criterion # 5: 

Symptomatic response to the run-in GC is defined as at least 1 moderate to severe GI 
symptom (either diarrhea, abdominal pain, bloating, or nausea) on the day of the GC.
Either/or

Symptom severity will be assessed using CDSD v2.1 scores on the day of the GC (see 
Section 8.2.3.1). 
8.2.2. Plasma IL-2 Biomarker Assessment
Plasma samples will be collected to assess the magnitude of biomarker response of IL-2 pre-
and post-GC in peripheral blood (Part A – exploratory endpoint; Part B and Part C – primary 
endpoint on Day 15 and secondary endpoints on Weeks 12, 24, and 36).
Further details are presented in Section 8.7.
8.2.3. Patient Reported Outcomes
8.2.3.1. CDSD v2.1
The CDSD v2.1, a novel patient-reported outcome measure developed for use with patients 
with CeD, consists of five symptoms including diarrhea, abdominal pain, bloating, nausea, 
and tiredness. The CDSD v2.1 assesses severity, in five scales from “none” to “very severe”,
and frequency. The CDSD v2.1 will be assessed daily as part of the eDiary beginning during 
the screening period after signing the ICD.
The CDSD v2.1 should be completed for at least a minimum of 7 consecutive days during 
screening at any time prior to the baseline visit (Day 1) in Part A and Part C and prior to run-
in GC visit (Day -21) for Part B. After screening and through the end of the study, 
compliance with the CDSD v2.1 is defined as 80% completion. 
8.2.3.2. PGIC
The PGIC is a patient-completed question to assess the overall impression of disease 
improvement experienced by the patient. The PGIC score ranges from “much better” to 
“much worse”. The PGIC will be assessed at visits specified in SoA.
8.2.3.3. PGIS
The PGIS is a patient-completed question to assess the overall impression of disease severity 
experienced by the patient. The PGIS score ranges from “None” to “Very Severe”. The PGIS 
will be assessed at visits specified in SoA. 
8.2.4. Esophagogastroduodenoscopy With Biopsy (Biopsy Substudy Only)
As part of the biopsy substudy in Part B and Part C, EGD with biopsies will be collected 
from participants at applicable sites at times specified in the SoA. 
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Urine pregnancy test may be performed prior to EGDC per local practice guidelines. EGD
with biopsy will be performed by a qualified gastroenterologist at each site. All study 
gastroenterologists will be trained on the study-specific procedures for obtaining the biopsy, 
including the location and number of biopsies to be obtained, and procedures for storing and 
shipping of samples. 
Approximately 6 duodenal biopsies will be obtained.
Endoscopy data obtained previously during screening up to 3 months prior to rescreening 
may be used as the baseline histology in a subject who has continued GFD and has not 
undergone a GC.
8.2.4.1. Histological Assessments (Biopsy Substudy only)
Tissue samples collected during biopsy as specified in the SoA will be analyzed for 
histological state (including, but not limited to: villus height, crypt depth, Marsh score, and 
IEL count) (see Appendix 10). Histology will be centrally read by qualified raters.
Management of Incidental Findings
An incidental finding is one unknown to the participant that has potential health or 
reproductive importance, which is discovered unexpectedly in the course of a research study, 
but is unrelated to the purpose and beyond the aims of the study.
Histology from EGD biopsy will be reviewed by a central review facility. The purpose of this 
review is to evaluate histology for celiac disease. Central histological review is not a 
complete medical review of the participant. If, during the central review process, an 
unexpected observation is identified and this finding could, in the opinion of the central 
reviewer, have a significant health or reproductive consequence, this finding may be shared 
with the study sponsor for disclosure to the PI. All follow-up testing and final diagnosis will 
be left to the discretion of the medical professionals at the site or those with an existing 
physician--participant relationship. The PI will be responsible for reporting any AEs 
identified from incidental findings as described in the AE reporting section. Identification of 
such incidental findings during the central review process should not be expected, and the 
site maintains responsibility for performing a general safety review of all histology as per site 
protocols. 
8.3. Safety Assessments
Safety will be assessed through the monitoring of AEs, clinical signs and symptoms, vital 
signs and clinical laboratory evaluations. 
All participants will be monitored continuously for AEs from screening until the safety 
follow-up visit on Week 52. AE severity will be assessed using the NCI CTCAE v5.0 or 
higher (see Appendix 10). The DSMB will review all SAEs and ≥Grade 3 AEs that are 
assessed to be related to study drug as these events may occur. Any Grade 4 AEs assessed as 
related to study drug will result in notification of the FDA in parallel with the DSMB. 
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Participants will be monitored in the clinic for 4 hours following IV study drug 
administration for IRR (see Appendix 9).
For Part A, the DSMB will review cumulative safety data by dose cohort before opening a 
higher dose cohort. DLTs are defined in Section 4.1.1.1.1. Any DLT experienced during the 
Treatment period (Day 1 to Day 7) through Day 15 prior to GC will result in a pause in the 
study enrollment and a review of all available safety data by the DSMB prior to dosing any 
additional participants; further details for cohort stopping rules are presented in 
Section 6.6.1.1.
In relation to participant safety during the COVID-19 pandemic, current national laws and 
local recommendations should be strictly adhered to during the study. 
Planned time points for all safety assessments are provided in the SoA. Unscheduled safety 
measurements may be obtained at any time during the study to assess any perceived safety 
issues.
8.3.1. Incidental Gluten Exposure Assessment
Incidental gluten exposure will be assessed daily as part of the participant’s eDiary.
Assessment of any incidental gluten exposure will be reviewed at all study visits. 
8.3.2. Vital Signs
Any untoward vital sign findings that are identified during the active collection period and 
meet the definition of an AE or SAE (Appendix 3) must be reported according to the 
processes in Sections 8.4.1 to 8.4.3.
Vital signs will be monitored during and after study intervention infusions to assess for IRR 
(see Appendix 9). Vital signs will be taken before collection of laboratory tests. Height and 
weight will also be measured and recorded at screening only and captured on the CRF.
BP and PR assessment consists of a single measure of BP and a single PR. Sitting BP and PR
measurement will be assessed with a completely automated device. 
Manual techniques will be used only if an automated device is not available. BP and PR
measurement should be preceded by at least 5 minutes of rest with the participant in a sitting 
position, in a quiet setting without distractions.
In amendment 3, Part C orthostatic vital signs including SBP, DBP, and PR will be collected
as follows:

Approximately 5 minutes pre-dose;

Approximately 45 minutes, 2 hours, and then, every 2 hours until discharge, post dose.
Additionally, if a participant experiences treatment-emergent clinically significant orthostatic 
hypotension or syncope, then, in addition to supportive care, orthostatic vital signs including 
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DBP, SBP, and PR will be collected every 2 hours, until discharge. Note: if planned 
assessments (pre-dose and 45 min, 2 hr and 4 hour post-dose) overlap unplanned 
assessments, orthostatic vital signs will be measured only once, not twice at that time.
Measurement of orthostatic vital signs (SBP, DBP, and PR) will occur after:  
1. participant has rested in supine position for 5 minutes
2. participant is in standing position for 1 min
3. Participant is in standing position for 3 minutes 
Note: Clinically significant orthostatic hypotension (OH) is defined by a fall in systolic blood 
pressure over 20 mmHg or a fall of in diastolic pressure over 10 mm Hg within 3 minutes of 
standing. An increase in heart rate of over 30 bpm suggests postural tachycardia 
syndrome.(Freeman et al, 2011) In case of above, a Grade 3 AE will be documented.  
8.3.2.1. Oral Temperature and Respiratory Rate
For Parts A and B, oral temperature and respiratory rate will be assessed. Temperature and 
respiratory rate findings collected during the study will be considered source data and will 
not be required to be reported, unless otherwise noted.
For Part C, oral temperature and RR will be assessed and recorded in clinical database at 
timepoints described in the SoA, ie,

Approximately 5 minutes pre-dose;

Approximately 45 minutes, 2 hours, and then, every 2 hours until discharge from the unit 
post dose.
Additionally, if a participant experiences treatment-emergent, clinically significant 
orthostatic hypotension or syncope, then, in addition to supportive care, temperature and RR 
will be collected every 2 hours, until discharge. Note: if planned assessments (pre-dose and 
45 min, 2 hr and 4 hour post-dose) overlap unplanned assessments, temperature and RR will 
be measured only once, not twice at that time.
8.3.3. Electrocardiograms
A standard 12-lead ECG utilizing limb leads (with a 10-second rhythm strip) should be 
collected at screening using an ECG machine that automatically calculates the HR and 
measures PR interval, QT interval, QTcF, and QRS complex. Alternative lead placement 
methodology using torso leads (eg, Mason-Likar) should not be used given the potential risk 
of discrepancies with ECGs acquired using standard limb lead placement. The ECG should 
be performed prior to blood draws and after the participant has rested quietly for at least 
5 minutes in a supine position. When collected, ECG values should be entered in clinical 
database. 
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Unscheduled ECGs are permitted per the investigator’s discretion.
In some cases, it may be appropriate to repeat abnormal ECGs to rule out improper lead 
placement as contributing to the ECG abnormality. If a machine-read QTc value is 
prolonged, as defined above, repeat measurements may not be necessary if a qualified 
medical provider’s interpretation determines that the QTcF values are in the acceptable 
range.
ECG values of potential clinical concern are listed in Appendix 8.
8.3.4. Clinical Safety Laboratory Assessments
Fasting at least 8 hours is required for the clinical safety laboratory tests. See Appendix 2 for 
the list of clinical safety laboratory tests to be performed and the SoA for the timing and 
frequency. All protocol required- laboratory assessments, as defined in Appendix 2, must be 
conducted in accordance with the laboratory manual and the SoA. Unscheduled clinical 
laboratory measurements may be obtained at any time during the study to assess any 
perceived safety issues.
The Investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study in the AE section of the CRF.
Clinically significant abnormal laboratory test findings are those that are not associated with 
any underlying disease, unless judged by the investigator to be more severe than expected for 
the participant’s condition.
All laboratory tests with values considered clinically significant and abnormal during 
participation in the study or within the follow-up period after the last dose of study 
intervention should be repeated until the values return to normal or baseline or are no longer 
considered clinically significant by the investigator or study medical monitor.
As part of amendment 3, if a participant experiences treatment-emergent, clinically 
significant orthostatic hypotension, syncope or treatment-related TEAE Grade 3 or above, 
then, in addition to supportive care, additional samples for safety laboratory tests 
(hematology, blood chemistry) will be collected.
If such values do not return to normal/baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified and the sponsor notified.
See Appendix 6 for suggested actions and follow-up assessments in the event of potential 
DILI.
See Appendix 7 for instructions for laboratory testing to monitor kidney function and 
reporting laboratory test abnormalities.
8.3.4.1. Alternative Facilities for Clinical Safety Laboratory Assessment
Protocol-specified safety laboratory evaluations will be conducted at a central laboratory.
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Non-protocol-specified laboratory evaluations as ordered by the investigator may be 
conducted at a local laboratory.
8.3.5. Physical Examinations
A complete physical examination will include, at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal, and neurological systems. Height and weight 
will also be measured and recorded at screening only.
Investigators should pay special attention to clinical signs related to previous serious 
illnesses. 
Physical examination findings collected during the study will be considered source data and 
will not be required to be reported, unless otherwise noted. Any untoward physical 
examination findings that are identified during the active collection period and meet the 
definition of an AE or SAE (Appendix 3) must be reported according to the processes in 
Sections 8.4.1 to 8.4.3.
8.3.6. Pregnancy Testing
A serum pregnancy test is required at screening. Following screening, pregnancy tests may 
be urine or serum tests, and must have a sensitivity of at least 25 mIU/mL. Pregnancy tests 
will be performed in WOCBP at the times listed in the SoA. Following a negative pregnancy 
test result at screening, appropriate contraception must be commenced and a second negative 
pregnancy test result will be required at the baseline visit prior to the participant’s receiving 
the study intervention. Pregnancy tests will also be done whenever 1 menstrual cycle is 
missed during the active treatment period (or when potential pregnancy is otherwise 
suspected) and at the end of the study. Pregnancy tests may also be repeated if requested by 
IRBs/ECs or if required by local regulations. If a urine test cannot be confirmed as negative 
(eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant 
must be excluded if the serum pregnancy result is positive.
8.4. Adverse Events, Serious Adverse Events, and Other Safety Reporting
The definitions of an AE and an SAE can be found in Appendix 3.
AEs may arise from symptoms or other complaints reported to the investigator by the 
participant (or, when appropriate, by a caregiver, surrogate, or the participant's legally 
authorized representative), or they may arise from clinical findings of the investigator or 
other healthcare providers (clinical signs, test results, etc).
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet the definition of an AE or SAE and remain responsible to pursue 
and obtain adequate information both to determine the outcome and to assess whether the 
event meets the criteria for classification as an SAE or caused the participant to discontinue 
the study intervention (see Section 7.1). 
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During the active collection period as described in Section 8.4.1, each participant will be 
questioned about the occurrence of AEs in a nonleading manner.
In addition, the investigator may be requested by the sponsor to obtain specific follow -up 
information in an expedited fashion.
8.4.1. Time Period and Frequency for Collecting AE and SAE Information
The time period for actively eliciting and collecting AEs and SAEs (“active collection 
period”) for each participant begins from the time the participant provides informed consent, 
which is obtained before undergoing any study-related procedure and/or receiving study 
intervention, through and including a minimum of 28 calendar days, except as indicated 
below, after the last administration of the study intervention.
Follow-up by the investigator continues throughout the active collection period and until the 
AE or SAE or its sequelae resolve or stabilize at a level acceptable to the investigator.
When a clinically significant AE remains ongoing at the end of the active collection period, 
follow-up by the investigator continues until the AE or SAE or its sequelae resolve or 
stabilize at a level acceptable to the investigator and the sponsor concurs with that 
assessment.
For participants who are screen failures, the active collection period ends when screen failure 
status is determined.
If the participant withdraws from the study and also withdraws consent for the collection of 
future information, the active collection period ends when consent is withdrawn.
If a participant permanently discontinues or temporarily discontinues study intervention 
because of an AE or SAE, the AE or SAE must be recorded on the CRF and the SAE 
reported using the CT SAE Report Form.
Investigators are not obligated to actively seek information on AEs or SAEs after the 
participant has concluded study participation. However, if the investigator learns of any SAE, 
including a death, at any time after a participant has completed the study, and they consider 
the event to be reasonably related to the study intervention, the investigator must promptly 
report the SAE to Pfizer Safety using the CT SAE Report Form.
8.4.1.1. Reporting SAEs to the Sponsor
All SAEs occurring in a participant during the active collection period as described in
Section 8.4.1 are reported to the sponsor on the CT SAE Report Form immediately upon 
awareness and under no circumstance should this exceed 24 hours, as indicated in 
Appendix 3. The investigator will submit any updated SAE data to Pfizer Safety within 
24 hours of its being available.
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8.4.1.2. Recording Nonserious AEs and SAEs on the CRF
All nonserious AEs and SAEs occurring in a participant during the active collection period, 
which begins after obtaining informed consent as described in Section 8.4.1, will be recorded 
on the AE section of the CRF.
The investigator is to record on the CRF all directly observed and all spontaneously reported 
AEs and SAEs reported by the participant.
As part of ongoing safety reviews conducted by the sponsor, any nonserious AE that is 
determined by the sponsor to be serious will be reported by the sponsor as an SAE. To assist 
in the determination of case seriousness, further information may be requested from the 
investigator to provide clarity and understanding of the event in the context of the clinical 
study.
8.4.2. Method of Detecting AEs and SAEs
The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3.
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and 
nonleading verbal questioning of the participant is the preferred method to inquire about 
AE occurrences.
8.4.3. Follow-Up of AEs and SAEs
After the initial AE or SAE report, the investigator is required to proactively follow each 
participant at subsequent visits/contacts. For each event, the investigator must pursue and 
obtain adequate information until resolution, stabilization, the event is otherwise explained, 
or the participant is lost to follow-up (as defined in Section 7.3).
In general, follow-up information will include a description of the event in sufficient detail to 
allow for a complete medical assessment of the case and independent determination of 
possible causality. Any information relevant to the event, such as concomitant medications 
and illnesses, must be provided. In the case of a participant death, a summary of available 
autopsy findings must be submitted as soon as possible to Pfizer Safety. 
Further information on follow-up procedures is provided in Appendix 3.
8.4.4. Regulatory Reporting Requirements for SAEs
Prompt notification by the investigator to Pfizer Safety of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of a 
study intervention under clinical investigation are met.
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will comply with country--specific regulatory requirements relating to safety 
reporting to the regulatory authority, IRBs/ECs, and investigators.
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Investigator safety reports must be prepared for SUSARs according to local regulatory 
requirements and sponsor policy and forwarded to investigators as necessary.
An investigator who receives SUSARs or other specific safety information (eg, summary or 
listing of SAEs) from the sponsor will review and then file it along with the SRSD(s) for the 
study and will notify the IRB/EC, if appropriate according to local requirements.
8.4.5. Environmental Exposure, Exposure During Pregnancy or Breastfeeding, and 
Occupational Exposure
Environmental exposure occurs when a person not enrolled in the study as a participant 
receives unplanned direct contact with or exposure to the study intervention. Such exposure 
may or may not lead to the occurrence of an AE or SAE. Persons at risk for environmental 
exposure include healthcare providers, family members, and others who may be exposed. An 
environmental exposure may include EDP, EDB, and occupational exposure.
Any such exposures to the study intervention under study are reportable to Pfizer within 24 
hours of investigator awareness.
8.4.5.1. Exposure During Pregnancy
An EDP occurs if:

A female participant is found to be pregnant while receiving or after discontinuing 
study intervention during the mandatory contraception period (see Appendix 4).

A male participant who is receiving or has discontinued study intervention 
inseminates a female partner during the mandatory contraception period (see 
Appendix 4).

A female nonparticipant is found to be pregnant while being exposed or having 
been exposed to study intervention because of environmental exposure. Below are 
examples of environmental EDP if they occur within 21 days after exposure:

A female family member or healthcare provider reports that she is pregnant after 
having been exposed to the study intervention by ingestion, inhalation, or skin 
contact.

A male family member or healthcare provider who has been exposed to the study 
intervention by ingestion, inhalation, or skin contact then inseminates his female 
partner prior to or around the time of conception.
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The investigator must report EDP to Pfizer within 24 hours of the investigator’s awareness, 
irrespective of whether an SAE has occurred. The initial information submitted should 
include the anticipated date of delivery (see below for information related to termination of 
pregnancy). 

If EDP occurs in a participant/participant’s partner, the investigator must report 
this information to Pfizer on the CT SAE Report Form and an EDP Supplemental 
Form, regardless of whether an SAE has occurred. Details of the pregnancy will 
be collected after the start of study intervention and until 12 weeks after the last 
dose.

If EDP occurs in the setting of environmental exposure, the investigator must 
report information to Pfizer using the CT SAE Report Form and EDP 
Supplemental Form. Since the exposure information does not pertain to the 
participant enrolled in the study, the information is not recorded on a CRF; 
however, a copy of the completed CT SAE Report Form is maintained in the 
investigator site file.
Follow-up is conducted to obtain general information on the pregnancy and its outcome for 
all EDP reports with an unknown outcome. The investigator will follow the pregnancy until 
completion (or until pregnancy termination) and notify Pfizer of the outcome as a follow-up 
to the initial-EDP Supplemental Form. In the case of a live birth, the structural integrity of 
the neonate can be assessed at the time of birth. In the event of a termination, the reason(s) 
for termination should be specified and, if clinically possible, the structural integrity of the 
terminated fetus should be assessed by gross visual inspection (unless preprocedure test 
findings are conclusive for a congenital anomaly and the findings are reported).
Abnormal pregnancy outcomes are considered SAEs. If the outcome of the pregnancy meets 
the criteria for an SAE (ie, ectopic pregnancy, spontaneous abortion, intrauterine fetal 
demise, neonatal death, or congenital anomaly in a live-born baby, a terminated fetus), the 
investigator should follow the procedures for reporting SAEs. Additional information about 
pregnancy outcomes that are reported to the sponsor as SAEs follows: 

Spontaneous abortion including miscarriage and missed abortion should be 
reported as an SAE;

Neonatal deaths that occur within 1 month of birth should be reported, without
regard to causality, as SAEs. In addition, infant deaths after 1 month should be 
reported as SAEs when the investigator assesses the infant death as related or 
possibly related to exposure to the study intervention. 
Additional information regarding the EDP may be requested by the sponsor. Further follow-
up of birth outcomes will be handled on a case-by-case basis (eg, follow--up on preterm 
infants to identify developmental delays). In the case of paternal exposure, the investigator 
will provide the participant with the Pregnant Partner Release of Information Form to deliver 
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to his partner. The investigator must document in the source documents that the participant 
was given the Pregnant Partner Release of Information Form to provide to his partner.
8.4.5.2. Exposure During Breastfeeding
An EDB occurs if:
A female participant is found to be breastfeeding while receiving or after 
discontinuing study intervention during the mandatory contraception period (see 
Appendix 4).
A female nonparticipant is found to be breastfeeding while being exposed or 
having been exposed to study intervention (ie, environmental exposure) within the 
last 21 days. An example of environmental EDB is a female family member or 
healthcare provider who reports that she is breastfeeding after having been 
exposed to the study intervention by ingestion, inhalation, or skin contact.
The investigator must report EDB to Pfizer within 24 hours of the investigator’s awareness, 
irrespective of whether an SAE has occurred. The information must be reported using the CT 
SAE Report Form. When EDB occurs in the setting of environmental exposure, the exposure 
information does not pertain to the participant enrolled in the study, so the information is not 
recorded on a CRF. However, a copy of the completed CT SAE Report Form is maintained in 
the investigator site file.
8.4.5.3. Occupational Exposure
The investigator must report any instance of occupational exposure to Pfizer within 24 hours 
of the investigator’s awareness using the CT SAE Report Form, regardless of whether there 
is an associated SAE. Since the information about the occupational exposure does not pertain 
to a participant enrolled in the study, the information is not recorded on a CRF; however, a 
copy of the completed CT SAE Report Form must be maintained in the investigator site file.
8.4.6. Cardiovascular and Death Events
Not applicable.
8.4.7. Disease -Related Events and/or Disease -Related Outcomes Not Qualifying as AEs 
or SAEs
Not applicable.
8.4.8. Adverse Events of Special Interest
Not applicable.
8.4.8.1. Lack of Efficacy
Not applicable. The primary objective of the study is to evaluate PD activity following 
treatment with multiple doses of KAN-101 versus PBO.
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8.4.9. Medical Device Deficiencies
Not applicable.
8.4.10. Medication Errors
Medication errors may result from the administration or consumption of the study 
intervention by the wrong participant, or at the wrong time, or at the wrong dosage strength.
Medication errors are recorded and reported as follows:
Recorded on the 
Medication Error Page 
of the CRF
Recorded on the 
Adverse Event Page 
of the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
All (regardless of whether 
associated with an AE)
Any AE or SAE associated 
with the medication error
Only if associated with an 
SAE
Medication errors include:

Medication errors involving participant exposure to the study intervention;

Potential medication errors or uses outside of what is foreseen in the protocol that 
do or do not involve the study participant.

Administration of a quantity of study intervention per administration or 
cumulative, which is above the maximum dose according to the protocol.

Unintentional error in dispensing or administration of study intervention not in 
accordance with the protocol.

Off-label use where study intervention is used for medicinal purpose not in 
accordance with the protocol.

Intentional and inappropriate misuse of study intervention not in accordance with 
the protocol.

Persistent or sporadic, intentional excessive use of study intervention, which is 
accompanied by harmful physical or psychological effects.

Exposure to study intervention because of one’s professional or non-professional 
occupation.
Such medication errors occurring to a study participant are to be captured on the medication 
error page of the CRF, which is a specific version of the AE page.
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Whether or not the medication error is accompanied by an AE, as determined by the 
investigator, the medication error is recorded on the medication error page of the CRF and, if 
applicable, any associated AE(s), serious and nonserious, are recorded on the AE page of the 
CRF.
In the event of a medication dosing error, Pfizer should be notified within 24 hours.
Medication errors should be reported to Pfizer within 24 hours on a CT SAE Report Form
only when associated with an SAE.
8.5. Pharmacokinetics 
Blood samples will be collected for measurement of plasma concentrations of KAN-101 as
specified in the SoA. Instructions for the collection and handling of biological samples will
be provided in the laboratory manual or by the sponsor. The actual date and time (24-hour
clock time) of each sample will be recorded. Samples collected for measurement of plasma 
concentrations of study intervention will be analyzed using a validated analytical method in 
compliance with applicable SOPs.
The actual times for PK assessment may change, and if needed, additional PK samples may 
be taken at times specified by Sponsor, provided the total blood volume taken during the 
study does not exceed 550 mL during any period of 56 consecutive days. All efforts will be 
made to obtain the samples at the exact nominal time relative to dosing. Collection of 
samples within 2 minutes for samples that are planned at less than 1 hour, and within 5 
minutes for samples planned between 1-7 hours after dose administration of the nominal time 
respectively relative to dosing will not be captured as a protocol deviation, as long as the 
exact time of the collection is noted on the source document and the CRF/DCT. 
Samples will be used to evaluate the PK of KAN-101. Samples collected for analyses of 
KAN-101 plasma concentration may also be used to evaluate safety or PD aspects related to 
concerns arising during or after the study, for metabolite identification and/or evaluation of 
the bioanalytical method, or for other internal exploratory purposes, and not reported in the 
CSR.
The PK samples must be processed and shipped as indicated in the instructions provided to 
the investigator site to maintain sample integrity. Any deviations from the PK sample 
handling procedure (eg, sample collection and processing steps, interim storage or shipping 
conditions), including any actions taken, must be documented and reported to Pfizer. On a 
case-by-case basis, the sponsor may make a determination as to whether sample integrity has 
been compromised.
Genetic analyses will not be performed on these whole blood samples unless consent for this 
was included in the informed consent. Participant confidentiality will be maintained.
Drug concentration information that may unblind the study will not be reported to 
investigator sites or blinded personnel until the study has been unblinded.
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Any changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment. The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD.
8.6. Genetics
8.6.1. Specified Genetics
To determine study eligibility, all participants will be assessed via central laboratory for 
HLA-DQ2.5 genotype (see Inclusion Criteria, Section 5.1) and absence of HLA-DQ8
genotype (see Exclusion Criteria, Section 5.2).
Details on processes for collection and shipment of these samples can be found in the study 
laboratory manual.
8.7. Biomarkers
Collection of samples for biomarker research is also part of this study.
In Part A, the following samples for biomarker research are required and will be collected
from all participants in the study at times specified in the SoA:

Plasma (plasma IL-2 biomarker assessment; see Section 8.2.2).

PBMC for future exploratory use.
In Part B, the following samples for biomarker research are required and will be collected 
from all participants in the study at times specified in the SoA:

Plasma for IL-2 (plasma IL-2 biomarker efficacy assessment; see Section 8.2.2)
In Part C, the following samples are required and will be collected from all participants as 
listed below:

Plasma for IL-2 for PD activity on Day 15, Weeks 12, 24, and 36 approximately 
5 minutes pre-GC and 4 hours (±15 minutes) post-completion of GC;

Plasma for other biomarkers on Days 1, 4, and 7 approximately 5 minutes pre-dose
and 4 hours (±15 minutes) post-end-of-infusion.
Note: In addition to planned plasma sample collection described above, if a 
participant experiences clinically significant orthostatic hypotension, syncope or a 
treatment-related TEAE Grade 3 or above, then, in addition to supportive care, 
additional plasma samples may be collected on Day 1, 4, or 7 for biomarkers.
Details on processes for collection and shipment of these samples can be found in the study 
laboratory manual.
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8.7.1. Residual Research Samples
Any remaining residual samples not used for protocol-specified assessments will be retained 
as local regulations and IRB/ECs allow.

Samples include, but are not limited to:
o
Plasma 
o
PBMC for biomarker assessments (Part A only)
o
Histopathology samples
Residual research samples may be used for research related to the study intervention(s) or 
celiac disease. Genes and other analytes (eg, proteins, RNA, nondrug metabolites) may be 
studied using the residual samples. 
See Appendix 5 for information regarding genetic research. Details on processes for 
collection and shipment of these samples can be found in the study laboratory manual. 
8.8. Immunogenicity Assessments
Blood samples will be collected for determination of ADA as specified in the SoA.
Instructions for the collection and handling of biological samples will be provided in the 
laboratory manual or by the sponsor. The actual date and time (24-hour clock time) of each 
sample will be recorded.
Samples collected for determination of ADA may also be used for additional characterization 
of the immune response and/or evaluation of the bioanalytical method, or for other internal 
exploratory purposes. These data will be used for internal exploratory purposes.
Genetic analyses will not be performed on these whole blood samples unless consent for this 
was included in the informed consent. Participant confidentiality will be maintained.
Samples will be analyzed using a validated analytical method in compliance with applicable
SOPs. 
The immunogenicity samples must be processed and shipped as indicated in the instructions 
provided to the investigator site to maintain sample integrity. Any deviations from the 
immunogenicity sample handling procedure (eg, sample collection and processing steps, 
interim storage, or shipping conditions), including any actions taken, must be documented 
and reported to Pfizer. On a case-by-case basis, the sponsor may make a determination as to 
whether sample integrity has been compromised.
Immunogenicity information that may unblind the study will not be reported to investigator 
sites or blinded personnel until the study has been unblinded.
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Any changes in the timing or addition of time points for any planned study assessments must 
be documented and approved by the relevant study team member and then archived in the 
sponsor and site study files, but will not constitute a protocol amendment. The IRB/EC will 
be informed of any safety issues that require alteration of the safety monitoring scheme or 
amendment of the ICD.
8.9. Health Economics
Health economics will not be assessed in this study.
9. STATISTICAL CONSIDERATIONS
Detailed methodology for summary and statistical analyses of the data collected in this study 
is outlined here and further detailed in the SAP, which will be maintained by the sponsor. 
The SAP may modify what is outlined in the protocol where appropriate; however, any major 
modifications of the primary endpoint definitions or their analyses will also be reflected in a 
protocol amendment.
9.1. Statistical Hypotheses
9.1.1. Estimands
9.1.1.1. Part B
Estimand 1 will be used for Part B primary endpoint:
Estimand 1: This estimand is a treatment policy, the observed data will be used for summary 
without regard to intercurrent events. It includes the following 5 attributes: 

Population: Participant with celiac disease as defined by the Part B inclusion and 
exclusion criteria.

Variable: Change in magnitude of IL-2 response pre-and post-GC from baseline to 
Day 15.

Treatment conditions: 3 dose groups of KAN-101 or PBO.

Intercurrent events: Intercurrent events will not be considered for analysis.

Population-level summary: Mean, geometric mean ratio of post-GC vs pre-GC in IL-
2 at Day -21 and Day 15 by treatment. 
9.1.1.2. Part C
Estimand 2 will be used for the primary endpoint main analysis in Part C.
Estimand 2: The primary estimand is the hypothetical estimand, which estimates the 
treatment effect of KAN-101 vs PBO for IL-2 under the scenario of no intercurrent events. It 
includes the following 5 attributes: 
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
Population: Participant with celiac disease as defined by the Part C inclusion and 
exclusion criteria.

Variable: log transformed IL-2 change from pre-GC to post-GC on Day 15. 

Treatment condition: 3 dose groups of KAN-101 or PBO.

Intercurrent event: Prohibited medication, incomplete GC on Day 15, and 
discontinuation of study intervention. All data collected after any intercurrent events 
will be excluded.

Population‑level summary: The LSM difference of the change from pre-GC to post-
GC (log transformed) between each KAN-101 group and PBO. 
9.1.2. Multiplicity Adjustment
There is no multiplicity adjustment. All hypothesis testings will be performed at a nominal 
significance level of 0.05 (2-sided).
9.2. Analysis Sets
For purposes of analysis, the following analysis sets are defined:
Participant Analysis Set
Description
Part A
Enrolled 
All participants who sign the ICD and are assigned to
study intervention in Part A.
Full analysis set
All participants who receive any portion of study 
intervention in Part A. 
Safety analysis set
All participants who receive any portion of study 
intervention in Part A. It is the same as FAS.
PK analysis set
All participants who apply any portion of study
intervention and have at least 1 concentration value in Part 
A.
Part B
Enrolled 
All participants who sign the ICD.
Full analysis set 
All participants who are randomly assigned to study 
intervention and receive any portion of study intervention
in Part B. Participants will be analyzed according to the 
intervention they are randomized.
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Participant Analysis Set
Description
Safety analysis set
All participants who receive any portion of study 
intervention in Part B. Participants will be analyzed
according to the intervention they actually received.
PK analysis set
All participants who receive any portion of study
intervention and have at least one concentration value in 
Part B.
Part C
Enrolled 
All participants who sign the ICD.
Full analysis set 
All participants who are randomly assigned to study 
intervention and receive any portion of study intervention 
in Part C. Participants will be analyzed according to the 
intervention they are randomized.
Safety analysis set
All participants who receive any portion of study 
intervention in Part C. Participants will be analyzed 
according to the intervention they actually received. 
PK analysis set
All participants who receive any portion of study
intervention and have at least one concentration value in 
Part C.
9.3. Statistical Analyses
The SAP will be developed and finalized before any analyses are performed and will 
describe the analyses and procedures for accounting for missing, unused, and spurious data.
This section is a summary of the planned statistical analyses of the primary and secondary 
endpoints.
9.3.1. General Considerations
Descriptive statistics will be used in general to summarize study results, ie, count and percent 
will be presented for binary endpoints and categorical endpoints; statistics for continuous 
variables will include number of observations, mean, standard deviation, minimum, 1st, 2nd, 
3rd quartiles, and maximum. The coefficient of variation and geometric mean will also be 
included, where appropriate. Graphics may be used to present the data.
A review will be conducted at the end of Part A to assess for preliminary safety and PK to 
confirm dose selection for Part B and Part C. This review will be exploratory in nature, so no 
formal statistical testing is planned; all analyses of Part A data will be descriptive only.
9.3.1.1. Analyses for Continuous Endpoints
For continuous endpoints in Part C, the change from baseline will be analyzed by timepoint 
using ANCOVA model with treatment as the factor, baseline as a covariate. Endpoints 
without baseline will be analyzed by ANOVA with treatment as the factor. Comparison of 
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KAN-101 to PBO (providing LSM of the treatments, LSM of the treatment difference, 
p‑value and 95% CI) will be generated. 
9.3.1.2. Missing Data Handling
No imputation for missing efficacy and safety data. Additional details for missing data 
handling will be provided in the SAP.
9.3.2. Primary Endpoints/Estimands Analysis
9.3.2.1. Definition of Endpoints
For Part A, the primary endpoint is incidence and severity of TEAEs as assessed by 
CTCAE. 
For Part B, the primary endpoint is change in magnitude of IL-2 response pre- and post-GC 
in peripheral blood from baseline screening to Day 15.
For Part C, the primary endpoint is change in IL-2 from pre-GC to post-GC on Day 15 in 
participants treated with KAN-101 versus PBO. 
9.3.2.2. Main Analytical Approach
For Part A, number and percent of participants with TEAEs will be summarized by: dose, 
SOC, PT, and severity.
For Part B, the primary endpoint will be descriptively summarized using estimand 1 (see 
Section 9.1.1.1) for FAS. No statistical hypothesis testing. 
For Part C, the primary endpoint, change in IL-2 from pre-GC to post-GC on Day 15 will be 
analyzed using ANOVA model as described in Section 9.1.1.2 and Section 9.3.1.1. 

The main analysis of the primary endpoint will be based on Estimand 2 (see
Section 9.1.1.2) using FAS. 

All statistical tests will be 2-tailed at a α = 0.05.
9.3.2.3. Sensitivity Analysis
For Part C, the sensitivity analysis will be based on treatment policy estimand using FAS.
Further details will be given in the SAP.
9.3.3. Secondary Endpoints Analysis
For Part A, PK concentration and PK parameters will be descriptively summarized by 
treatment group. The PK parameters to be assessed, their definition, and method of 
determination are detailed in Section 9.3.5. Actual PK sampling times will be used in the 
derivation of PK parameters.
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For Part B and Part C, 

Number and percent of participants with TEAEs will be summarized by treatment, 
SOC, PT, and severity. Number of TEAEs (all-causality and treatment-related) and 
percent of participants with TEAEs will also be summarized by treatment period, 
treatment, SOC, PT, and severity.

PK concentration and PK parameters will be descriptively summarized by treatment 
group.
9.3.4. Tertiary/Exploratory Endpoints Analysis
Results of exploratory endpoint analyses will be utilized for internal purposes and may not be 
described in the CSR.
For Part A,

Change in magnitude of IL-2 response pre-and-post GC in in peripheral blood at Day 
15 will be descriptively summarized by cohort.

KAN-101 PK parameters, as data permit: AUCinf (dn), AUClast (dn), Cmax (dn), CL, V, 
for analysis details see Section 9.3.5.

Incidence of development of ADA during the study, for analysis details see 
Section 9.3.7.
For Part B, 

PRO will be summarized to track CeD symptoms over the duration of the study for 
FAS. Further details will be provided in the SAP. 

Change in magnitude of IL-2 response pre- and post-GC in peripheral blood from 
baseline (run-in) to GC at Weeks 12, 24, and 36 will be descriptively summarized by 
timepoint for FAS.

Change in magnitude of IL-2 response pre- and post-GC in peripheral blood from 
Day 15 to Weeks 12, 24, and 36 will be descriptively summarized by timepoint for 
FAS as well.

KAN-101 PK parameters, as data permit: AUCinf (dn), AUClast (dn), Cmax (dn), CL, 
V, for analysis details see Section 9.3.5.

Incidence of development of ADA during the study, for analysis details see 
Section 9.3.7.
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For Part C, 

PRO will be analyzed using ANCOVA model by timepoint for FAS. Further details 
will be provided in the SAP. 

Change in circulating levels of IL-2 from pre-GC to post-GC at Weeks 12, 24, and 36 
will be analyzed using ANOVA model by timepoint for FAS. 

Change in circulating levels of IL-2 from pre-dose to post dose on Days 1, 4, and 7
will be analyzed using ANOVA model by timepoint for FAS. 

Change in circulating levels of IL-2 pre- and post-GC from Day 15 to Weeks 12, 24, 
and 36 will be analyzed using ANOVA model by timepoint for FAS.

KAN-101 PK parameters, as data permit: AUCinf (dn), AUClast (dn), Cmax (dn), CL, 
V, for analysis details see Section 9.3.5.

Incidence of development of ADA during the study, for analysis details see 
Section 9.3.7.
For Part B and Part C substudy, 

Change from baseline in histology (including, but not limited to, Marsh score, villous 
height crypt depth ratio, IEL counts) at Week 52 will be summarized by treatment for 
biopsy substudy.

Correlation between histological state, symptomatic response (PRO data) and 
biomarker responses (IL-2) will be provided.
9.3.5. Pharmacokinetic Analysis
Actual PK sampling times will be used in the derivation of PK parameters. The plasma
concentration of KAN-101 will be listed and descriptively summarized by nominal PK 
sampling time and treatment group. Individual subject, mean, and median profiles of the 
plasma concentration-time data will be plotted by treatment group using actual (for 
individual) and nominal (for median) times respectively. Mean and median profiles will be 
presented on both linear and log scales.
Table 2.
PK Parameters Analyzed
Parameter 
Definition
Method of Determination
AUClast
Area under the plasma concentration-time 
profile from time 0 to the time of the last 
quantifiable concentration (Clast)
Linear/Log trapezoidal method
AUClast (dn) 
Dose normalized AUClast
AUClast/Dose
AUCinf
Area under the plasma concentration-time 
profile from time 0 extrapolated to infinite time
AUClast + (Clast/kel),
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Table 2.
PK Parameters Analyzed
Parameter 
Definition
Method of Determination
where Clast is the predicted plasma concentration at 
the last quantifiable time point estimated from the 
log-linear regression analysis
AUCinf (dn)
Dose normalized AUCinf
AUCinf/Dose
Cmax
Maximum serum concentration 
Observed directly from data
Cmax (dn) 
Dose normalized Cmax
Cmax/dose
t½a
Terminal elimination half-life
Loge(2)/kel, where kel is the terminal phase rate 
constant calculated by a linear regression of the 
loglinear -concentration time- curve. Only those 
data points judged to describe the terminal 
log-linear decline will be used in the regression
CLa
Apparent systemic clearance
Dose/AUClast
Va
Apparent volume of distribution 
Dose/AUCinf×kel
a.
If data permits
The PK parameters in Table 2 will be summarized descriptively by treatment group in 
accordance with sponsor data standards. Summary statistics will also include the geometric 
mean and coefficient of variation for all parameters except Tmax. Where data permit, dose 
normalized (to a 1 mg dose) Cmax, AUCinf, and AUClast, will be plotted against dose (using a 
logarithmic scale). The plot will include individual subject values and the geometric means 
for each dose. These plots will be used to determine the relationship between PK parameters 
and dose. 
9.3.6. Safety Analyses
All the safety data will be summarized descriptively through appropriate data tabulations, 
descriptive statistics, and graphical presentations for Part A and Part B separately. All safety 
analyses will be performed on the safety population.
9.3.7. Other Analyses 
Immunogenicity assessments will be summarized descriptively. 
Biomarker data from Retained Research Samples may be collected during or after the trial 
and retained for future analyses; the results of such analyses are not planned to be included in 
the CSR. 
9.4. Interim Analyses
Interim analyses may be conducted and results may be used to inform internal decisions 
regarding future study planning. 
Before any interim analysis is performed, the details of the objectives, decision criteria,
dissemination plan, and method of maintaining the study blind (if applicable) as per the 
sponsor’s SOPs will be documented and approved in a DSMB charter. In addition, the 
analysis details will be documented and approved in the SAP.
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9.5. Sample Size Determination
It is anticipated that the study will enroll approximately 126 – 132 participants:

Part A = 6-12 participants

Part B = Approximately 16 participants

Part C = Approximately 104 participants

Biopsy Substudy (at applicable sites only) will enroll up to approximately 50% 
participants enrolled in Part B and up to approximately 50% participants enrolled in 
Part C. 
There is no formal power calculation for the open-label Part A. 
There is no formal power calculation for Part B. 
In Part C, assuming the mean difference in the change from pre-GC to post-GC of log-
transformed IL-2 levels on Day 15 is 2.37 between KAN-101 and PBO and the common 
standard deviation is 1.53, a sample size of 26 in each group will have 99% power, using a 2-
group t-test with a 5%, 2-sided significance level. The Part C sample size is large enough to 
offer insight into the exploratory endpoints. 
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10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations
10.1.1. Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines, including the 
Declaration of Helsinki and CIOMS International Ethical Guidelines;

Applicable ICH GCP guidelines;

Applicable laws and regulations, including applicable privacy laws.
The protocol, protocol amendments, ICD, SRSD(s), and other relevant documents (eg, 
advertisements) must be reviewed and approved by the sponsor, submitted to an IRB/EC by 
the investigator, and reviewed and approved by the IRB/EC before the study is initiated.
Any amendments to the protocol will require IRB/EC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
Protocols and any substantial amendments to the protocol will require health authority 
approval prior to initiation except for changes necessary to eliminate an immediate hazard to 
study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/EC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/EC;

Notifying the IRB/EC of SAEs or other significant safety findings as required by 
IRB/EC procedures;

Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH GCP guidelines, the IRB/EC, European regulation 
536/2014 for clinical studies, European Medical Device Regulation 2017/745 for 
clinical device research, and all other applicable local regulations.
10.1.1.1. Reporting of Safety Issues and Serious Breaches of the Protocol or ICH GCP
In the event of any prohibition or restriction imposed (ie, clinical hold) by an applicable 
regulatory authority in any area of the world, or if the investigator is aware of any new 
information that might influence the evaluation of the benefits and risks of the study 
intervention, the sponsor should be informed immediately. 
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In addition, the investigator will inform the sponsor immediately of any urgent safety 
measures taken by the investigator to protect the study participants against any immediate 
hazard, and of any serious breaches of this protocol or of the ICH GCP guidelines that the 
investigator becomes aware of.
10.1.2. Financial Disclosure
Investigators and subinvestigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators 
are responsible for providing information on financial interests during the course of the study 
and for 1 year after completion of the study.
10.1.3. Informed Consent Process
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the participant or their legally authorized representative
and answer all questions regarding the study. The participant or their legally authorized 
representative should be given sufficient time and opportunity to ask questions and to decide 
whether or not to participate in the trial.
Participants must be informed that their participation is voluntary. Participants or their legally 
authorized representative (if allowed by local regulations) will be required to sign a statement 
of informed consent that meets the requirements of 21 CFR 50, local regulations, ICH 
guidelines, privacy, and data protection requirements, where applicable, and the IRB/EC or 
study center.
The investigator must ensure that each participant or their legally authorized representative is 
fully informed about the nature and objectives of the study, the sharing of data related to the 
study, and possible risks associated with participation, including the risks associated with the 
processing of the participant’s personal data. 
The participant or their legally authorized representative must be informed that their personal 
study-related data will be used by the sponsor in accordance with local data protection law. 
The level of disclosure must also be explained to the participant or their legally authorized 
representative.
The participant or their legally authorized representative must be informed that their medical 
records may be examined by Clinical Quality Assurance auditors or other authorized 
personnel appointed by the sponsor, by appropriate IRB/EC members, and by inspectors 
from regulatory authorities.
The investigator further must ensure that each study participant or their legally authorized 
representative is fully informed about their right to access and correct their personal data and 
to withdraw consent for the processing of their personal data.
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The medical record must include a statement that written informed consent was obtained 
before the participant was enrolled in the study and the date on which the written consent was 
obtained. The authorized person obtaining the informed consent must also sign the ICD.
Participants or their legally authorized representative must be reconsented to the most current 
version of the IRB/EC-approved ICD(s) during their participation in the study as required per 
local regulations.
A copy of the ICD(s) must be provided to the participant or their legally authorized 
representative (if allowed by local regulations).
Participants who are rescreened are required to sign a new ICD.
10.1.4. Data Protection
All parties will comply with all applicable laws, including laws regarding the implementation 
of organizational and technical measures to ensure protection of participant data.
Participants’ personal data will be stored at the study site in encrypted electronic and/or paper 
form and will be password protected or secured in a locked room to ensure that only 
authorized study staff have access. The study site will implement appropriate technical and 
organizational measures to ensure that the personal data can be recovered in the event of 
disaster. In the event of a potential personal data breach, the study site will be responsible for 
determining whether a personal data breach has in fact occurred and, if so, providing breach 
notifications as required by law.
To protect the rights and freedoms of participants with regard to the processing of personal 
data, participants will be assigned a single, participant-specific numerical code. Any 
participant records or data sets that are transferred to the sponsor will contain the numerical 
code; participant names will not be transferred. All other identifiable data transferred to the 
sponsor will be identified by this single, participant-specific code. The study site will 
maintain a confidential list of participants who participated in the study, linking each 
participant’s numerical code to their actual identity and medical record ID. In case of data 
transfer, the sponsor will protect the confidentiality of participants’ personal data consistent 
with the clinical study agreement and applicable privacy laws.
Information technology systems used to collect, process, and store study-related data are 
secured by technical and organizational security measures designed to protect such data 
against accidental or unlawful loss, alteration, or unauthorized disclosure or access.
The sponsor maintains standard operating procedures on how to respond in the event of 
unauthorized access, use, or disclosure of sponsor information or systems.
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10.1.5. Committees Structure
10.1.5.1. Data Monitoring Committee 
This study will use a DSMB. The DSMB is independent of the study team and includes 
voting external members. The DSMB charter describes the role of the DSMB in more detail.
The DSMB will be responsible for ongoing monitoring of the safety of participants in the 
study according to the charter. The recommendations made by the DSMB will be forwarded 
to the appropriate authorized sponsor personnel for review and final decision. The sponsor
will communicate such decisions, which may include summaries of aggregate analyses of 
safety data, to regulatory authorities and investigators, as appropriate. 
10.1.6. Dissemination of Clinical Study Data
The sponsor fulfills its commitment to publicly disclose clinical study results through posting 
the results of studies on www.clinicaltrials.gov (ClinicalTrials.gov), the EudraCT/CTIS, and 
other public registries and websites in accordance with applicable local laws/regulations. In 
addition, the sponsor reports study results outside of the requirements of local 
laws/regulations pursuant to its SOPs.
In all cases, study results are reported by the sponsor in an objective, accurate, balanced, and 
complete manner and are reported regardless of the outcome of the study or the country in 
which the study was conducted.
www.clinicaltrials.gov
The sponsor posts clinical trial results on www.clinicaltrials.gov for Kanyos Bio, 
Inc.-sponsored interventional studies (conducted in patients) that evaluate the safety and/or 
efficacy of a product, regardless of the geographical location in which the study is conducted. 
These results are submitted for posting in accordance with the format and timelines set forth 
by US law.
EudraCT/CTIS
The sponsor posts clinical trial results on EudraCT/CTIS for Kanyos Bio, Inc.-sponsored 
interventional studies in accordance with the format and timelines set forth by EU 
requirements.
Documents within marketing applications
The sponsor complies with applicable local laws/regulations to publish clinical documents 
included in marketing applications. Clinical documents include summary documents and 
CSRs including the protocol and protocol amendments, sample CRFs, and SAPs. Clinical 
documents will have personally identifiable information anonymized.
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Data sharing
The sponsor provides researchers secure access to participant-level data or full CSRs for the 
purposes of “bona-fide scientific research” that contributes to the scientific understanding of 
the disease, target, or compound class. The sponsor will make data from these trials available 
18 months after study completion. Participant-level data will be anonymized in accordance 
with applicable privacy laws and regulations. CSRs will have personally identifiable 
information anonymized.
Data requests are considered from qualified researchers with the appropriate competencies to 
perform the proposed analyses. Research teams must include a biostatistician. Data will not 
be provided to applicants with significant conflicts of interest, including individuals 
requesting access for commercial/competitive or legal purposes.
10.1.7. Data Quality Assurance
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (eg, laboratory data). The investigator is 
responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
Guidance on completion of CRFs will be provided in the CRF Completion Requirements 
document.
The investigator must ensure that the CRFs are securely stored at the study site in encrypted 
electronic and/or paper form and are password protected or secured in a locked room to 
prevent access by unauthorized third parties.
The investigator must permit study-related monitoring, audits, IRB/EC review, and 
regulatory agency inspections and provide direct access to source records and documents.
This verification may also occur after study completion. It is important that the 
investigator(s) and their relevant personnel are available during the monitoring visits and 
possible audits or inspections and that sufficient time is devoted to the process.
Monitoring details describing strategy, including definition of study-critical data items and 
processes (eg, risk-based initiatives in operations and quality such as risk management and 
mitigation strategies and analytical risk-based monitoring), methods, responsibilities, and 
requirements, including handling of noncompliance issues and monitoring techniques 
(central, virtual, or on-site monitoring), are provided in the data management plan and 
monitoring plan maintained and utilized by the sponsor or designee.
The sponsor or designee is responsible for the data management of this study, including 
quality checking of the data.
Records and documents, including signed ICDs, pertaining to the conduct of this study must 
be retained by the investigator for 15 years after study completion unless local regulations or 
institutional policies require a longer retention period. No records may be destroyed during 
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the retention period without the written approval of the sponsor. No records may be 
transferred to another location or party without written notification to the sponsor. The 
investigator must ensure that the records continue to be stored securely for as long as they are 
maintained.
When participant data are to be deleted, the investigator will ensure that all copies of such 
data are promptly and irrevocably deleted from all systems.
The investigator(s) will notify the sponsor or its agents immediately of any regulatory 
inspection notification in relation to the study. Furthermore, the investigator will cooperate 
with the sponsor or its agents to prepare the investigator site for the inspection and will allow 
the sponsor or its agent, whenever feasible, to be present during the inspection. The 
investigator site and investigator will promptly resolve any discrepancies that are identified 
between the study data and the participant’s medical records. The investigator will promptly 
provide copies of the inspection findings to the sponsor or its agent. Before response 
submission to the regulatory authorities, the investigator will provide the sponsor or its 
agents with an opportunity to review and comment on responses to any such findings.
10.1.8. Source Documents
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator site.
Data reported on the CRF or entered in the eCRF that are from source documents must be 
consistent with the source documents or the discrepancies must be explained. The 
investigator may need to request previous medical records or transfer records, depending on 
the study. Also, current medical records must be available.
In this study, the CRF will serve as the source document. A document must be available at 
the investigative site that identifies those data that will be recorded on the CRF and for which 
the CRF will be the source document.
Definition of what constitutes a source document and its origin can be found in the Source 
Document Locator, which is maintained by the sponsor or sponsor’s designee (Pfizer).
Description of the use of the computerized system is documented in the Data Management 
Plan, which is maintained by the sponsor.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF.
The sponsor or designee will perform monitoring to confirm that data entered into the CRF 
by authorized site personnel are accurate, complete, and verifiable from source documents; 
that the safety and rights of participants are being protected; and that the study is being 
conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP guidelines, and all applicable regulatory requirements.
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10.1.9. Study and Site Start and Closure
The study start date is the date of the first participant’s first visit.The sponsor designee 
reserves the right to close the study site or terminate the study at any time for any reason at 
the sole discretion of the sponsor, including (but not limited to) regulatory authority decision, 
change in opinion of the IRB/EC, or change in benefit-risk assessment. Study sites will be 
closed upon study completion. A study site is considered closed when all required documents 
and study supplies have been collected and a study -site closure visit has been performed.
The investigator may initiate study -site closure at any time upon notification to the sponsor 
or designee (Pfizer) if requested to do so by the responsible IRB/EC or if such termination is 
required to protect the health of study participants.
Reasons for the early closure of a study site by the sponsor may include but are not limited 
to:

Failure of the investigator to comply with the protocol, the requirements of the 
IRB/EC or local health authorities, the sponsor’s procedures, or the ICH GCP 
guidelines;

Inadequate recruitment of participants by the investigator;

Discontinuation of further study intervention development.
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the ECs/IRBs, the regulatory authorities, and any CRO(s) used in the study of 
the reason for termination or suspension, as specified by the applicable regulatory 
requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up.
Study termination is also provided for in the clinical study agreement. If there is any conflict 
between the contract and this protocol, the contract will control as to termination rights.
10.1.10. Publication Policy
Publication by the clinical study site(s) of any data from this study must be carried out in 
accordance with the Clinical Site Agreement. 
10.1.11. Sponsor’s Medically Qualified Individual 
The sponsor will designate a medically qualified individual (MQI, also known as the medical 
monitor) to advise the investigator on study-related medical questions. The contact 
information for the study medical monitor is documented in the Study Team Contact List
located in the ISF or equivalent. 
Participants are provided with a Pfizer study information card at the time of informed consent
which includes contact information for their investigator in case of study-related medical 
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questions. The study information card contains, at a minimum, (a) study number, (b) 
participant’s study identification number, and (c) principal investigator contact information.
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10.2. Appendix 2: Clinical Laboratory Tests
The following safety laboratory tests will be performed at times defined in the SoA section of 
this protocol. Additional laboratory results may be reported on these samples as a result of 
the method of analysis or the type of analyzer used by the clinical laboratory, or as derived 
from calculated values. These additional tests would not require additional collection of 
blood. Unscheduled clinical laboratory measurements may be obtained at any time during the 
study to assess any perceived safety issues.
Clinical laboratory tests should be performed prior to KAN-101/PBO infusion when 
applicable. 
Table 3.
Protocol Required Safety Laboratory Assessments
Hematology
Chemistry
Urinalysis
Other
Hemoglobin
Hematocrit
RBC count
Platelet count
WBC count
Total neutrophils (Abs, 
%)
Eosinophils (Abs,%)
Monocytes (Abs,%)
Basophils (Abs,%)
Lymphocytes (Abs,%)
PT
aPTTa
INRa
Urea and creatinine
eGFR
Glucose (fasting)
Calcium
Sodium
Potassium
Chloride
Total CO2 (bicarbonate)
AST, ALT
Total and direct bilirubin
Alkaline phosphatase
Uric acid
Albumin
Total protein
Magnesium
Amylase
Lipase
Phosphorus
hsCRPb
Local dipstick:
pH
Glucose (qual)
Protein (qual)
Blood (qual)
Ketones
Nitrites
Leukocyte esterase
Laboratory:
Microscopy and culturec
At screening:
FSHd
Pregnancy test 
(β-hCG)e
HBsAg and HBcAb. 
HBsAb and HBV 
DNA as reflex tests
Hepatitis C antibody
and HCV RNA as 
reflex testHIV
HLA genotype and 
CeD serology (eg, 
HLA DQ2.5 and HLA 
DQ8 testingf, tTG and 
DGP IgA/IgGg)
a.
aPTT and INR tests are performed in Part A only. 
b.
Part C only: At times indicated in the SoA (Section 1.3.3).
c.
Only if UTI is suspected and urine dipstick is positive for nitrites or leukocyte esterase or both.
d.
For confirmation of postmenopausal status only.
e.
A serum pregnancy test is required at screening. Following screening, local urine testing will be standard 
for the protocol unless serum testing is required by local regulation or IRB/EC. Serum or urine hCG for 
female participants of childbearing potential.
f.
For re-screening, the HLA does not need to be repeated and CeD serology (the tTG and DGP antibody 
tests) should only be repeated if >3 months have elapsed from previous assessment.
g.
For tTG, a result of ≤ 10 U/mLi will be considered negative or weak positive. For DGP, a result of 
<30 U/mL will be considered negative or weak positive.
The investigator must review the laboratory report, document this review, and record any 
clinically relevant changes occurring during the study in the AE section of the CRF. 
Laboratory/analyte results that could unblind the study and have been collected for the 
purpose of the study will not be reported to investigator sites or other blinded personnel until 
the study has been unblinded.
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10.3. Appendix 3: Adverse Events: Definitions and Procedures for Recording, 
Evaluating, Follow-Up, and Reporting
10.3.1. Definition of AE
AE Definition

An AE is any untoward medical occurrence in a patient or clinical study 
participant, temporally associated with the use of study intervention, whether or not 
considered related to the study intervention.

Note: An AE can therefore be any unfavorable and unintended sign (including an 
abnormal laboratory finding), symptom, or disease (new or exacerbated) 
temporally associated with the use of study intervention.
Events Meeting the AE Definition

Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) 
or other safety assessments (eg, ECG, radiological scans, vital sign measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator. Any abnormal test results that 
meet any of the conditions below must be recorded as an AE:
Is associated with accompanying symptoms.
Requires additional diagnostic testing or medical/surgical intervention.
Leads to a change in study dosing (outside of any protocol-specified dose 
adjustments) or discontinuation from the study, significant additional 
concomitant drug treatment, or other therapy.

Exacerbation of a chronic or intermittent preexisting condition, including an 
increase in either frequency and/or intensity of the condition.

New condition detected or diagnosed after study intervention administration, even 
though it may have been present before the start of the study.

Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction.

Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
intervention or a concomitant medication. Overdose per se will not be reported as 
an AE or SAE unless it is an intentional overdose taken with possible suicidal/self-
harming intent. Such overdoses should be reported regardless of sequelae.
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Events NOT Meeting the AE Definition

Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition.

The disease/disorder being studied or expected progression, signs, or symptoms of 
the disease/disorder being studied, unless more severe than expected for the 
participant’s condition.

Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE.

Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital).

Anticipated day-to-day fluctuations of preexisting disease(s) or condition(s) present 
or detected at the start of the study that do not worsen.
10.3.2. Definition of an SAE
An SAE is defined as any untoward medical occurrence that, at any dose, meets one 
or more of the criteria listed below:
a. Results in death
b. Is life-threatening
The term “life-threatening” in the definition of “serious” refers to an event in which the 
participant was at risk of death at the time of the event. It does not refer to an event that
hypothetically might have caused death if it were more severe.
c.
Requires inpatient hospitalization or prolongation of existing hospitalization
In general, hospitalization signifies that the participant has been admitted (usually 
involving at least an overnight stay) at the hospital or emergency ward for observation 
and/or treatment that would not have been appropriate in the physician’s office or 
outpatient setting. Complications that occur during hospitalization are AEs. If a 
complication prolongs hospitalization or fulfills any other serious criteria, the event is 
serious. When in doubt as to whether “hospitalization” occurred or was necessary, the 
AE should be considered serious.
Hospitalization for elective treatment of a preexisting condition that did not worsen 
from baseline is not considered an AE.
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d. Results in persistent or significant disability/incapacity

The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions.

This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma (eg, sprained ankle), that may interfere with or 
prevent everyday life functions but do not constitute a substantial disruption.
e.
Is a congenital anomaly/birth defect
f.
Is a suspected transmission via a Kanyos Bio, Inc. product of an infectious agent, 
pathogenic or nonpathogenic
The event may be suspected from clinical symptoms or laboratory findings indicating 
an infection in a participant exposed to a Kanyos Bio, Inc. product. The terms 
“suspected transmission” and “transmission” are considered synonymous. These cases 
are considered unexpected and handled as serious expedited cases by 
pharmacovigilance personnel. Such cases are also considered for reporting as product 
defects, if appropriate.
g. Other situations:

Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations, such as significant
medical events that may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious.

Examples of such events include invasive or malignant cancers, intensive treatment 
in an emergency room or at home for allergic bronchospasm, blood dyscrasias or 
convulsions that do not result in hospitalization, or development of drug 
dependency or drug abuse.
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10.3.3. Recording/Reporting and Follow-Up of AEs and/or SAEs During the Active 
Collection Period 
AE and SAE Recording/Reporting
The table below summarizes the requirements for recording AEs on the CRF and for 
reporting SAEs on the CT SAE Report Form to Pfizer Safety throughout the active 
collection period. These requirements are delineated for 3 types of events: (1) SAEs; (2) 
nonserious AEs; and (3) exposure to the study intervention under study during pregnancy 
or breastfeeding, and occupational exposure. 
It should be noted that the CT SAE Report Form for reporting of SAE information is not 
the same as the AE page of the CRF. When the same data are collected, the forms must be 
completed in a consistent manner. AEs should be recorded using concise medical 
terminology and the same AE term should be used on both the CRF and the CT SAE 
Report Form for reporting of SAE information.
Safety Event
Recorded on the CRF
Reported on the CT SAE 
Report Form to Pfizer 
Safety Within 24 Hours of 
Awareness
SAE
All
All
Nonserious AE
All
None
Exposure to the study 
intervention under study 
during pregnancy or 
breastfeeding 
All AEs or SAEs associated 
with EDP or EDB
Note: Instances of EDP or 
EDB not associated with an 
AE or SAE are not captured 
in the CRF
All instances of EDP are 
reported (whether or not 
there is an associated 
SAE)*
All instances of EDB are 
reported (whether or not 
there is an associated 
SAE)**
Environmental or 
occupational exposure to 
the product under study to 
a nonparticipant (not 
involving EDP or EDB)
None. Exposure to a study 
nonparticipant is not 
collected on the CRF
The exposure (whether or 
not there is an associated 
AE or SAE) must be 
reported***
*
EDP (with or without an associated SAE): is reported to Pfizer Safety using the CT SAE Report 
Form and EDP Supplemental Form; if the EDP is associated with an SAE, then the SAE is reported to 
Pfizer Safety using the CT SAE Report Form. 
** EDB is reported to Pfizer Safety using the CT SAE Report Form, which would also include details 
of any SAE that might be associated with the EDB. 
*** Environmental or occupational exposure: AEs or SAEs associated with occupational exposure 
are reported to Pfizer Safety using the CT SAE Report Form. 
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
When an AE or SAE occurs, it is the responsibility of the investigator to review all 
documentation (eg, hospital progress notes, laboratory reports, and diagnostic 
reports) related to the event.

The investigator will then record all relevant AE or SAE information in the CRF.

It is not acceptable for the investigator to send photocopies of the participant’s 
medical records to Pfizer Safety in lieu of completion of the CT SAE Report 
Form/AE or SAE CRF page.

There may be instances when copies of medical records for certain cases are 
requested by the sponsor/Pfizer Safety. In this case, all participant identifiers, with 
the exception of the participant number, will be redacted on the copies of the 
medical records before submission to Pfizer Safety.

The investigator will attempt to establish a diagnosis of the event based on signs, 
symptoms, and/or other clinical information. Whenever possible, the diagnosis (not 
the individual signs/symptoms) will be documented as the AE or SAE.
Assessment of Intensity
The investigator will make an assessment of intensity for each AE and SAE reported 
during the study and assign it to 1 of the categories listed below (as defined by the NCI 
CTCAE system).
GRADE
Clinical Description of Intensity
1
MILD AE
2
MODERATE AE
3
SEVERE AE
4
LIFE-THREATENING; urgent intervention indicated
5
DEATH RELATED TO AE
Further details regarding the CTCAE are presented in Appendix 10.
An event is defined as “serious” when it meets at least 1 of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.
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Assessment of Causality

The investigator is obligated to assess the relationship between study intervention 
and each occurrence of each AE or SAE. The investigator will use clinical 
judgment to determine the relationship.

A “reasonable possibility” of a relationship conveys that there are facts, evidence, 
and/or arguments to suggest a causal relationship, rather than a relationship cannot 
be ruled out.

Alternative causes, such as underlying disease(s), concomitant therapy, and other 
risk factors, as well as the temporal relationship of the event to study intervention 
administration, will be considered and investigated.

The investigator will also consult the IB and/or product information, for marketed 
products, in their assessment.

For each AE or SAE, the investigator must document in the medical notes that they 
have reviewed the AE or SAE and have provided an assessment of causality.

There may be situations in which an SAE has occurred and the investigator has 
minimal information to include in the initial report to Pfizer Safety . However, it is 
very important that the investigator always make an assessment of causality 
for every event before the initial transmission of the SAE data to Pfizer Safety.

The investigator may change their opinion of causality in light of follow-up 
information and send an SAE follow-up report with the updated causality 
assessment.

The causality assessment is one of the criteria used when determining regulatory 
reporting requirements.

If the investigator does not know whether or not the study intervention caused the 
event, then the event will be handled as “related to study intervention” for reporting 
purposes, as defined by Pfizer Safety. In addition, if the investigator determines 
that an SAE is associated with study procedures, the investigator must record this 
causal relationship in the source documents and CRF, and report such an 
assessment in the dedicated section of the CT SAE Report Form and in accordance 
with the SAE reporting requirements.
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Follow-Up of AEs and SAEs

The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations, as medically indicated or as requested by the 
sponsor/Pfizer Safety, to elucidate the nature and/or causality of the AE or SAE as 
fully as possible. This may include additional laboratory tests or investigations, 
histopathological examinations, or consultation with other healthcare providers.

If a participant dies during participation in the study or during a recognized follow-
up period, the investigator will provide Pfizer Safety with a copy of any 
postmortem findings, including histopathology.

New or updated information will be recorded in the originally submitted 
documents.

The investigator will submit any updated SAE data to Pfizer Safety within 24 hours 
of receipt of the information.
10.3.4. Reporting of SAEs
SAE Reporting to Sponsor Safety via an Electronic DCT

The primary mechanism for reporting an SAE to Pfizer Safety will be the 
electronic DCT.

If the electronic system is unavailable, then the site will use the paper SAE DCT
(see next section) to report the event within 24 hours.

The site will enter the SAE data into the electronic DCT (eg, eSAE or PSSA) or 
paper form (as applicable) as soon as the data become available.

After the study is completed at a given site, the electronic DCT will be taken 
off-line to prevent the entry of new data or changes to existing data.

If a site receives a report of a new SAE from a study participant or receives updated 
data on a previously reported SAE after the electronic DCT has been taken off-line, 
then the site can report this information on a paper SAE form (see next section) or 
to Pfizer Safety by telephone.
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SAE Reporting to Sponsor Safety via the CT SAE Report Form

Facsimile transmission of the CT SAE Report Form is the preferred method to 
transmit this information to Pfizer Safety.

In circumstances when the facsimile is not working, an alternative method should 
be used, eg, secured (Transport Layer Security) or password-protected email. If 
none of these methods can be used, notification by telephone is acceptable with a 
copy of the CT SAE Report Form sent by overnight mail or courier service.

Initial notification via telephone does not replace the need for the investigator to 
complete and sign the CT SAE Report Form pages within the designated reporting 
time frames.
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10.4. Appendix 4: Contraceptive and Barrier Guidance 
10.4.1. Male Participant Reproductive Inclusion Criteria (Parts A and B)
Male participants are eligible to participate if they agree to the following requirements during 
the intervention period and for at least 21 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate reproductive safety risk of the study 
intervention(s):

Refrain from donating sperm.
PLUS either:

Be abstinent from heterosexual or homosexual intercourse as their preferred and usual 
lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.
OR

Must agree to use a male condom when engaging in any activity that allows for 
passage of ejaculate to another person.

The male participant should be advised of the benefit for a WOCBP partner using a 
highly effective method of contraception with a failure rate of <1% per year, as 
described in Section 10.4.4.
10.4.2. Female Participant Reproductive Inclusion Criteria (Parts A and B)
The criteria below are part of Inclusion Criterion 1 (Age and Sex; Section 5.1) and specify 
the reproductive requirements for including female participants. Refer to Section 10.4.4 for a 
complete list of contraceptive methods permitted in the study. 

A female participant is eligible to participate if she (a) is not pregnant or 
breastfeeding; and (b) agrees not to donate eggs (ova, oocytes) for the purpose of 
reproduction for 21 days after the last dose of study intervention; and (c) at least 1 of the 
following conditions applies:

Is not a WOCBP (see definition in Section 10.4.3).
OR

Is a WOCBP and agrees to use a contraceptive method that is highly effective (failure 
rate of <1% per year) with low user dependency during the intervention period and 
agrees to use it for at least 21 days after the last dose of study intervention, which 
corresponds to the time needed to eliminate any reproductive safety risk of the study 
intervention(s). The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.
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OR

Is a WOCBP and agrees to use a highly effective (failure rate of <1% per year) user-
dependent method of contraception during the intervention period and for at least 21 
days after the last dose of study intervention, which corresponds to the time needed to 
eliminate any reproductive safety risk of the study intervention(s). In addition to her 
use of the highly effective method above, she agrees to concurrently use an effective 
barrier method. The investigator should evaluate the effectiveness of the 
contraceptive method in relationship to the first dose of study intervention.
The investigator is responsible for review of medical history, menstrual history, and recent 
sexual activity to decrease the risk for inclusion of a woman with an early undetected 
pregnancy. 
10.4.3. Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal 
unless permanently sterile (see below).
If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual cycle cannot 
be confirmed before the first dose of study intervention, additional evaluation should be 
considered.
Women in the following categories are not considered WOCBP:
1. Premenopausal female with 1 of the following:

Documented hysterectomy;

Documented bilateral salpingectomy;

Documented bilateral oophorectomy.
For individuals with permanent infertility due to a medical cause other than the above (eg, 
mullerian agenesis, androgen insensitivity), investigator discretion should be applied to 
determining study entry.
Note: Documentation for any of the above categories can come from the site personnel’s 
review of the participant’s medical records, medical examination, or medical history 
interview. The method of documentation should be recorded in the participant’s medical 
record for the study.
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2. Postmenopausal female:

A postmenopausal state is defined as no menses for 12 months without an alternative 
medical cause. In addition:

A high FSH level in the postmenopausal range must be used to confirm a 
postmenopausal state in women under 60 years of age and not using hormonal 
contraception or HRT. 

A female on HRT and whose menopausal status is in doubt will be required to use 
one of the highly effective nonestrogen hormonal contraception methods if she
wishes to continue her HRT during the study. Otherwise, she must discontinue HRT 
to allow confirmation of postmenopausal status before study enrollment.
10.4.4. Contraception Methods
Contraceptive use by men or women should be consistent with local availability/regulations 
regarding the use of contraceptive methods for those participating in clinical trials.
The following contraceptive methods are appropriate for this study:
Highly Effective Methods That Have Low User Dependency 
1. Implantable progestogen-only hormone contraception associated with inhibition of 
ovulation.
2. Intrauterine device.
3. Intrauterine hormone-releasing system.
4. Bilateral tubal occlusion.
5. Vasectomized partner.

Vasectomized partner is a highly effective contraceptive method provided that the 
partner is the sole sexual partner of the WOCBP and the absence of sperm has 
been confirmed. If not, an additional highly effective method of contraception 
should be used. The spermatogenesis cycle is approximately 90 days.
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10.5. Appendix 5: Genetics
Use/Analysis of DNA

Genetic variation may impact a participant’s response to study intervention, 
susceptibility to, and severity and progression of disease.  Therefore, where local 
regulations and IRBs/ECs allow, a blood sample will be collected for DNA analysis.

The results of genetic analyses may be reported in the CSR or in a separate study 
summary, or may be used for internal decision making without being included in a 
study report.

The sponsor will store the DNA samples in a secure storage space with adequate 
measures to protect confidentiality. 

The samples will be retained as indicated:

Samples for specified genetic analysis (see Section 8.6.1) will not be stored 
beyond the completion of this study (eg, CSR finalization), unless the participant 
agrees to optional additional research on these samples.

Samples for genetic research will be labeled with a code. The key between the code 
and the participant’s personally identifying information (eg, name, address) will be 
held securely at the study site.  
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10.6. Appendix 6: Liver Safety: Suggested Actions and Follow-Up Assessments 
Potential Cases of Drug-Induced Liver Injury
Humans exposed to a drug who show no sign of liver injury (as determined by elevations in 
transaminases) are termed “tolerators,” while those who show transient liver injury but adapt 
are termed “adaptors.” In some participants, transaminase elevations are a harbinger of a 
more serious potential outcome. These participants fail to adapt and therefore are 
“susceptible” to progressive and serious liver injury, commonly referred to as DILI. 
Participants who experience a transaminase elevation above 3 × ULN should be monitored 
more frequently to determine if they are “adaptors” or are “susceptible.”
In the majority of DILI cases, elevations in AST and/or ALT precede T bili elevations (>2 × 
ULN) by several days or weeks. The increase in T bili typically occurs while AST/ALT is/are 
still elevated above 3 × ULN (ie, AST/ALT and T bili values will be elevated within the same 
laboratory sample). In rare instances, by the time T bili elevations are detected, AST/ALT 
values might have decreased. This occurrence is still regarded as a potential DILI. Therefore, 
abnormal elevations in either AST OR ALT in addition to T bili that meet the criteria outlined 
below are considered potential DILI (assessed per Hy’s law criteria) cases and should always 
be considered important medical events, even before all other possible causes of liver injury
have been excluded.
The threshold of laboratory abnormalities for a potential DILI case depends on the 
participant’s individual baseline values and underlying conditions. Participants who present 
with the following laboratory abnormalities should be evaluated further as potential DILI 
(Hy’s law) cases to definitively determine the etiology of the abnormal laboratory values:

Participants with AST/ALT and T bili baseline values within the normal range who 
subsequently present with AST OR ALT values ≥3 × ULN AND a T bili value 
≥2 × ULN with no evidence of hemolysis and an alkaline phosphatase value 
<2 × ULN or not available.

For participants with baseline AST OR ALT OR T bili values above the ULN, the 
following threshold values are used in the definition mentioned above, as needed, 
depending on which values are above the ULN at baseline:

Preexisting AST or ALT baseline values above the normal range: AST or 
ALT values ≥2 times the baseline values AND ≥3 × ULN; or ≥8 × ULN 
(whichever is smaller).

Preexisting values of T bili above the normal range: T bili level increased 
from baseline value by an amount of ≥1 × ULN or if the value reaches 
≥3 × ULN (whichever is smaller).
Rises in AST/ALT and T bili separated by more than a few weeks should be assessed 
individually based on clinical judgment; any case where uncertainty remains as to whether it 
represents a potential Hy’s law case should be reviewed with the sponsor. 
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The participant should return to the investigator site and be evaluated as soon as possible, 
preferably within 48 hours from awareness of the abnormal results. This evaluation should 
include laboratory tests, detailed history, and physical assessment.
In addition to repeating measurements of AST and ALT and T bili for suspected Hy’s law
cases, additional laboratory tests should include albumin, CK, direct and indirect bilirubin, 
GGT, PT/INR, total bile acids, and alkaline phosphatase. Consideration should also be given 
to drawing a separate tube of clotted blood and an anticoagulated tube of blood for further 
testing, as needed, for further contemporaneous analyses at the time of the recognized initial 
abnormalities to determine etiology. A detailed history, including relevant information, such 
as review of ethanol, acetaminophen/paracetamol (either by itself or as a coformulated 
product in prescription or over-the-counter medications), recreational drug, or supplement 
(herbal) use and consumption, family history, sexual history, travel history, history of contact 
with a jaundiced person, surgery, blood transfusion, history of liver or allergic disease, and 
potential occupational exposure to chemicals, should be collected. Further testing for acute 
hepatitis A, B, C, D, and E infection, liver imaging (eg, biliary tract), and collection of serum 
samples for acetaminophen/paracetamol drug and/or protein adduct levels may be warranted. 
All cases demonstrated on repeat testing as meeting the laboratory criteria of AST/ALT and 
T bili elevation defined above should be considered potential DILI (Hy’s law) cases if no 
other reason for the LFT abnormalities has yet been found. Such potential DILI (Hy’s law) 
cases are to be reported as SAEs, irrespective of availability of all the results of the 
investigations performed to determine etiology of the LFT abnormalities.
A potential DILI (Hy’s law) case becomes a confirmed case only after all results of 
reasonable investigations have been received and have excluded an alternative etiology.
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10.7. Appendix 7: Kidney Safety Monitoring Guidelines
10.7.1. Laboratory Assessment of Change in Kidney Function and Detection of Kidney 
Injury
Standard kidney safety monitoring requires assessment of baseline and postbaseline serum 
creatinine (Scr measurement to eGFR [Scr-based eGFR] or [eCrCl]). Baseline and 
postbaseline Scys makes it feasible to distinguish AKI from other causes of Scr increase. If 
Scr increase is confirmed after baseline, then reflex measurement of Scys is indicated to 
estimate the combined Scr-Scys eGFR calculation (for adults only).
Regardless of whether kidney function monitoring tests are required as a routine safety 
monitoring procedure in the study, if the investigator or sponsor deems it necessary to further 
assess kidney safety and quantify kidney function, then these test results should be managed 
and followed per standard of care.
10.7.2. Age-Specific Kidney Function Calculation Recommendations
10.7.2.1. Adults (18 Years and Above)—2021 CKD-EPI Equations
2021 CKD-
EPI          
Scr Only
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤ 0.7
N/A
eGFR = 143 × (Scr/0.7)-0.241  ×  (0.9938)Age
Female
if > 0.7
N/A
eGFR = 143 × (Scr/0.7)-1.200  ×  (0.9938)Age
Male
if ≤ 0.9
N/A
eGFR = 142 × (Scr/0.9)-0.302  ×  (0.9938)Age
Male
if > 0.9
N/A
eGFR = 142 × (Scr/0.9)-1.200  ×  (0.9938)Age
2021 CKD-
EPI          
Scr-Scys 
Combined
Scr
(mg/dL)
Scys
(mg/L)
Recommended eGFR Equation
Female
if ≤ 0.7
if ≤ 0.8
eGFR = 130 × (Scr/0.7)-0.219  × (Scys/0.8)-0.323  × (0.9961)Age
Female
if ≤ 0.7
if > 0.8
eGFR = 130 × (Scr/0.7)-0.219  × (Scys/0.8)-0.778  × (0.9961)Age
Female
if > 0.7
if ≤ 0.8
eGFR = 130 × (Scr/0.7)-0.544  × (Scys/0.8)-0.323  × (0.9961)Age
Female
if > 0.7
if > 0.8
eGFR = 130 × (Scr/0.7)-0.544  × (Scys/0.8)-0.778  × (0.9961)Age
Male
if ≤ 0.9
if ≤ 0.8
eGFR = 135 × (Scr/0.9)-0.144  × (Scys/0.8)-0.323  × (0.9961)Age
Male
if ≤ 0.9
if > 0.8
eGFR = 135 × (Scr/0.9)-0.144  × (Scys/0.8)-0.778  × (0.9961)Age
Male
if > 0.9
if ≤ 0.8
eGFR = 135 × (Scr/0.9)-0.544  ×  (Scys/0.8)-0.323  × (0.9961)Age
Male
if > 0.9
if > 0.8
eGFR = 135 × (Scr/0.9)-0.544  ×  (Scys/0.8)-0.778  × (0.9961)Age
(Inker et al, 2021)
10.7.3. Adverse Event Grading for Kidney Safety Laboratory Abnormalities
AE grading for decline in kidney function (ie, eGFR or eCrCl) will be according to KDIGO
criteria.
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10.8. Appendix 8: ECG Findings of Potential Clinical Concern
ECG Findings That May Qualify as AEs

Marked sinus bradycardia (rate <40 bpm) lasting minutes.

New PR interval prolongation >280 Ms.

New prolongation of QTcF to >480 ms (absolute) or by ≥60 ms from baseline.

New-onset atrial flutter or fibrillation, with controlled ventricular response rate: ie, 
rate <120 bpm.

New-onset type I second-degree (Wenckebach) AV block of >30 seconds’
duration.

Frequent PVCs, triplets, or short intervals (<30 seconds) of consecutive ventricular 
complexes.
ECG Findings That May Qualify as SAEs

QTcF prolongation >500 ms.

New ST-T changes suggestive of myocardial ischemia.

New-onset LBBB (QRS complex >120 ms).

New-onset right bundle branch block (QRS complex >120 ms).

Symptomatic bradycardia.

Asystole:

In awake, symptom-free participants in sinus rhythm, with documented periods 
of asystole ≥3.0 seconds or any escape rate <40 bpm, or with an escape rhythm 
that is below the AV node; 

In awake, symptom-free participants with atrial fibrillation and bradycardia 
with 1 or more pauses of at least 5 seconds or longer; 

Atrial flutter or fibrillation, with rapid ventricular response rate: rapid = rate 
>120 bpm.

Sustained supraventricular tachycardia (rate >120 bpm) (“sustained” = short 
duration with relevant symptoms or lasting >1 minute).
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
Ventricular rhythms >30 seconds’ duration, including idioventricular rhythm (HR
<40 bpm), accelerated idioventricular rhythm (HR 40 bpm to <100 bpm), and 
monomorphic/polymorphic ventricular tachycardia (HR >100 bpm [such as
torsades de pointes]).

Type II second-degree (Mobitz II) AV block.

Complete (third-degree) heart block.
ECG Findings That Qualify as SAEs

Change in pattern suggestive of new myocardial infarction.

Sustained ventricular tachyarrhythmias (>30 seconds’ duration).

Second- or third-degree AV block requiring pacemaker placement.

Asystolic pauses requiring pacemaker placement.

Atrial flutter or fibrillation with rapid ventricular response requiring cardioversion.

Ventricular fibrillation/flutter.

At the discretion of the investigator, any arrhythmia classified as an adverse 
experience.
The enumerated list of major events of potential clinical concern are recommended as “alerts” or 
notifications from the core ECG laboratory to the investigator and the sponsor study team, and not to be 
considered as all-inclusive of what to be reported as AEs/SAEs.
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10.9. Appendix 9: Infusion-Related Reactions
Participants will be monitored in the clinic for 4 hours following IV study drug 
administration for IRR. IRR may include, but are not limited to: erythema, induration, 
ecchymosis, pain, and pruritus. 
If an IRR occurs during study intervention administration, the following treatment 
recommendations are provided and may be modified per local treatment standards and 
guidelines as appropriate:

Grade 1 (mild): Infusion rate modification not indicated. Administer symptomatic 
treatment (eg, antihistamines, antipyretics, antiemetics) as needed. Closely monitor 
participant until resolution. Prophylaxis with diphenhydramine 50 mg (or equivalent) 
and/or acetaminophen/paracetamol 325 to 1000 mg is recommended at least 30 min prior 
to future study intervention infusions.

Grade 2 (moderate): Slow infusion rate to ≤ 50% of the original infusion rate and treat 
symptoms with appropriate medical therapy, including but not limited to antihistamines, 
antipyretics, and analgesics. Increase monitoring of vital signs as medically indicated 
until participant is deemed stable. Prophylaxis with diphenhydramine 50 mg (or 
equivalent) and/or acetaminophen/paracetamol 325 to 1000 mg is recommended at least 
30 min prior to future study intervention infusions.

Grade 3 (severe): Stop infusion and institute appropriate symptom-directed therapy, 
including but not limited to antihistamines, antipyretics, corticosteroids, bronchodilators, 
and O2. Increase monitoring of vital signs as medically indicated until participant is 
deemed stable.

If the reaction has not resolved within 6 hours, the remainder of the infusion will not 
be administered and study intervention will be permanently discontinued.

Following the completion or termination of a restarted infusion due to an IRR:

All participants must be monitored until resolution of symptoms or for 2 hours in 
the absence of additional symptoms.

Prophylaxis with diphenhydramine 50 mg (or equivalent) and/or 
acetaminophen/paracetamol 325 to 1000 mg is recommended at least 30 min prior 
to future study intervention infusions.

The next infusion should initiate at a rate of 2 hours per dose, or 50% of the rate 
at which the reaction occurred. If no IRRs are observed within the first 30 
minutes, the infusion rate may increase to 30-minutes-per dose rate as outlined in 
Section 6.1.1. 

If second occurrence of Grade 3 or greater IRR, permanently discontinue study 
intervention.
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
Grade 4 (life-threatening): Stop infusion and immediately institute appropriate 
symptom directed therapy and supportive measures as necessary, including but not 
limited to, corticosteroids, bronchodilators, O2/respiratory support, and vasopressors. 
Hospitalization and/or intensive care unit admission may be indicated. 

Permanently discontinue study intervention.
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10.10. Appendix 10: Common Terminology Criteria For Adverse Events 
CTCAE Terms
AEs are defined in Appendix 3. An AE is a term that is a unique representation of a specific 
event used for medical documentation and scientific analyses. Each CTCAE term as a 
MedDRA Lowest Level Term. The latest available version of CTCAE will be used
(NCI NIH, 2017).
Definitions
A brief definition is provided to clarify the meaning of each AE term.
Grades
Grade refers to the severity of the AE and are specified in Appendix 3. Further details are 
provided below. CTCAE v5.0 grades for GI disorders frequently observed in the FIH study
KAN-101-01 are provided in Table 4.
The CTCAE displays Grades 1 through Grade 5 with unique clinical descriptions of severity 
for each AE based on this general guideline:

Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated

Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting 
age appropriate instrumental ADL*

Grade 3: Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting 
selfcare ADL**

Grade 4: Life-threatening consequences; urgent intervention indicated

Grade 5: Death related to AE
A semi-colon indicates ‘or’ within the description of the grade.
A single dash (-) indicates a grade is not available.
Not all grades are appropriate for all AEs. Therefore, some AEs are listed with fewer than 5 
options for Grade selection. Grade 5 (Death) is not appropriate for some AEs and is therefore 
not an opinion. 
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Table 4.
CTCAE v5.0 Grades for GI Disorders Observed in KAN-101-01 (FIH 
Study)
CTCAE Term
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Nausea
Loss of appetite 
without 
alteration in 
eating habits
Oral intake 
decreased without 
significant weight 
loss, dehydration or 
malnutrition
Inadequate oral caloric or 
fluid intake; tube feeding, 
TPN, or hospitalization 
indicated
-
-
Abdominal 
pain
Mild pain
Moderate pain, 
limiting
instrumental ADL
Severe pain; limiting 
selfcare ADL
-
-
Vomiting
Intervention not 
indicated
Outpatient IV 
hydration; medical 
intervention 
indicated
Tube feeding, TPN, or 
hospitalization indicated
Life-
threatening 
consequences
Death
Constipation
Occasional or 
intermittent 
symptoms; 
occasional use of 
stool softeners, 
laxatives, dietary 
modification, or 
enema
Persistent symptoms 
with regular use of 
laxatives or enemas; 
limiting 
instrumental ADL
Obstipation with manual 
evacuation indicated; 
limiting selfcare ADL
Life-
threatening 
consequences; 
urgent 
intervention 
indicated
Death
Diarrhea
Increase of <4 
stools per day 
over baseline; 
mild increase in 
ostomy output 
compared to 
baseline
Increase of 4 - 6 
stools per day over 
baseline; moderate 
increase in ostomy 
output compared to 
baseline; limiting 
instrumental ADL
Increase of >=7 stools per 
day over baseline; 
hospitalization indicated; 
severe increase in ostomy 
output compared to 
baseline; limiting selfcare 
ADL
Life-
threatening 
consequences; 
urgent 
intervention 
indicated
Death
Dyspepsia
Mild symptoms; 
intervention not 
indicated
Moderate 
symptoms; medical 
intervention 
indicated
Severe symptoms; 
operative intervention 
indicated
-
-
Flatulence
Mild symptoms; 
intervention not 
indicated
Moderate 
symptoms; 
psychosocial 
sequelae
-
-
-
Activities of Daily Living
* Instrumental ADL refer to preparing meals, shopping for groceries or clothes, using the 
telephone, managing money, etc.
** Selfcare ADL refer to bathing, dressing and undressing, feeding self, using the toilet, 
taking medications, and not bed ridden. 
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10.11. Appendix 11: Marsh Criteria for Diagnosis of Celiac Disease
Diffuse intraepithelial lymphocytosis, normal villi, consistent with celiac 
disease
Marsh type 1
Diffuse intraepithelial lymphocytosis and crypt hyperplasia, consistent 
with celiac
disease
Marsh type 2
Partial villus atrophy, crypt hyperplasia and intraepithelial 
lymphocytosis, consistent
with celiac disease
Marsh type 3a
Subtotal villus atrophy, crypt hyperplasia and intraepithelial 
lymphocytosis, consistent
with celiac disease
Marsh type 3b
Total villus atrophy, crypt hyperplasia and intraepithelial lymphocytosis, 
consistent with
celiac disease
Marsh type 3c
Villus atrophy, crypt hypoplasia and intraepithelial lymphocytosis, 
consistent with celiac
disease
Marsh type 4
Lagana & Bhagat. 2019
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10.12. Appendix 12: Protocol Amendment History
The protocol amendment summary of changes table for the current amendment is located 
directly before the TOC. The protocol amendment summary of changes tables for past 
amendment(s) can be found below:
Amendment 2 (06 Nov 2023)
Document 
Version Date
Summary of Changes
Rationale for 
Changes
Protocol 
Amendment 2
06 November 
2023
Extended the screening period 
to 28 days in Part B prior to 
run-in GC in following 
sections: 

Synopsis,

Schema (Section 
1.2.2),

SoA (Section 1.3.2) 
for Part B,

Overall Design Part B 
(Section 4.1.2).
Screening window is 
extended to 28 days to
accommodate 
potential longer time 
needed for HLA 
genotyping and CeD 
serology.  
Clarified  fasting requirement 
on the days for safety 
laboratory and GC in 
following sections: 

SoA (Section 1.3.2) in 
Part B,

Section 8.2.1 and 
8.3.4 
To provide 
consistency and 
clarity for fasting 
requirements for 
safety laboratory tests 
and GC. 
Clarified urine pregnancy 
tests collected prior to run-in 
GC, and that urine pregnancy 
test prior to EGD should be 
performed per local practice 
guidelines in SoA (Section 
1.3) in Part B.
Text clarification for 
urine pregnancy test 
requirements.
Changed cutoff of tTG in 
inclusion criterion #4 from 
<2x ULN to ≤10 U/mL in 
sections: 

Synopsis 

Inclusion Criteria 
(Section 5.1).
To provide clear 
definition for
‘negative or weak 
positive’ based on 
central laboratory 
cutoff.
Clarified using premedication 
for study intervention in 
Allow permitted 
premedication for 
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Document 
Version Date
Summary of Changes
Rationale for 
Changes
Section 6.1.1 and 6.9.3. in 
Part B.
management of AEs 
during study 
intervention. 
Inserted Marsh criteria for 
diagnosis of celiac disease in 
Appendix 10.11, citation to 
Appendix 10.11 in Inclusion 
Criterion #2and the added 
reference to Section 11, 
References.
The insertion provides 
the reference to Marsh 
score.
Other minor administrative 
changes for clarification.
Provide consistency 
throughout the 
document.
Amendment 1 (21 Jun 2023)
Document 
Version Date
Summary of Changes
Rationale for 
Changes
Protocol 
Amendment 1
16 June 2023
Changes made to the 
following sections of the 
protocol to Part A and Part B 
of the study design to 
eliminate 6.0 mg/kg in Part A 
as dose Cohort 3, and define 
0.6 mg/kg, 1.2 mg/kg, and 3.0 
mg/kg as active study drug 
arms and placebo in Part B;

Synopsis, 

Study Design Schema, 

Overall Design (4.1), 

Justification for Dose
(4.3), 

Study Intervention(s) 

Administered (6.1), 
and 

Statistical 
Considerations (9) 
Changes. 
Newly emerging 
clinical data from Part 
A supports 
progression to Part B 
following completion 
of 3.0 mg/kg cohort in 
Part A and safety 
review by DSMB. The 
Sponsor has made 
revisions, to the study 
design to eliminate the 
6.0 mg/kg dose cohort 
in Part A and confirm 
0.6 mg/kg, 1.2 mg/kg, 
3.0 mg/kg and placebo 
as treatment arms for 
Part B of the study. 
Clarification of PK sampling 
time points in Schedule of 
Activities.
Changes in PK 
sampling notes in both 
Part A and B to clarify 
the use of infusion 
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Document 
Version Date
Summary of Changes
Rationale for 
Changes
start time as reference 
timepoint for post-
dose PK collections.
Clarify requirements for 
EGD, HLA genotyping and 
CeD serology in rescreening 
participants in Schedule of 
Activities, Section 5.4, Screen 
Failures, Section 8.2.4 
Esophagogastroduodenoscopy 
With Biopsy, and Appendix 
10.2 Clinical Laboratory 
Tests
Changes made in 
these sections to be 
consistent throughout 
the protocol. 
Remove requirements that are 
not applicable for the study in 
Section 6.5 for Study 
Intervention Compliance
Removed 
requirements that are 
not applicable with the 
current version of 
IPM.
Other administrative changes 
throughout the document
Administrative 
Changes to make 
clarifications and 
consistencies 
throughout the 
document. 
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10.13. Appendix 13: Abbreviations
The following is a list of abbreviations that may be used in the protocol. 
Abbreviation
Term
Abs
absolute
ADA
anti-drug antibodies
ADL
activity/activities of daily living
AE
adverse event
AKI
acute kidney injury
ALP
alkaline phosphatase
ALT
alanine aminotransferase
ANC
absolute neutrophil count
ANCOVA
analysis of covariance
ANOVA
analysis of variance
aPTT
activated partial thromboplastin time
AST
aspartate aminotransferase
AUC
area under the curve
AUCinf (dn) 
dose normalized AUCinf
AUCinf
area under the plasma-concentration curve from time 0 extrapolated
to infinite time
AUClast
area under the plasma concentration-time profile from time 0 to the 
time of the last quantifiable concentration (Clast)
AUClast (dn)
dose normalized AUClast
AV
atrioventricular
AxMP
auxiliary medicinal product
-hCG
-human chorionic gonadotropin
BL
baseline 
BP
blood pressure
bpm
beats per minute
CDSD
Celiac Disease Symptom Diary
CeD
celiac disease
CFR
Code of Federal Regulations
CI
confidence interval
CIOMS
Council for International Organizations of Medical Sciences
CK
creatine kinase
CKD-EPI
chronic kidney disease epidemiology 
Clast
last quantifiable concentration
Cmax
maximum plasma concentration 
Cmax (dn) 
dose normalized Cmax
CO2
carbon dioxide (bicarbonate)
COVID-19
coronavirus disease 2019
CL
apparent systemic clearance
CRF
case report form
CRO
contract research organization
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Abbreviation
Term
CSR
Clinical Study Report
CT
clinical trial
CTCAE
Common Terminology Criteria for Adverse Events
CTIS
Clinical Trial Information System
CV
cardiovascular
DBP
diastolic blood pressure
DCT
data collection tool
DGP
deamidated gliadin peptide(s)
DILI
drug-induced liver injury
DLT
dose limiting toxicity(ies)
DNA
deoxyribonucleic acid
DSMB
Data Safety Monitoring Board
DU
dispensable unit
EAE
experimental autoimmune encephalomyelitis
EC
ethics committee
ECG
electrocardiogram or electrocardiography
eCrCl
estimated creatinine clearance
eCRF
electronic case report form
EDB
exposure during breastfeeding
EDP
exposure during pregnancy
EFD
embryonic fetal development
EGD
esophagogastroduodenoscopy
eGFR
estimated glomerular filtration rate
eSAE
electronic serious adverse event
ET
early termination
EU
European Union
EudraCT
European Union Drug Regulating Authorities Clinical Trials 
(European Clinical Trials Database)
FAS
full analysis set
FDA
Food and Drug Administration
FIH
First-in-human
FSH
follicle-stimulating hormone
FU
follow-up
GC
gluten challenge
GCP
Good Clinical Practice
GFD
gluten-free diet
GGT
gamma-glutamyl transferase
GI
gastrointestinal
GLP
good laboratory practice
HBcAb
hepatitis B core antibody
HBsAb
hepatitis B surface antibody
HBsAg
hepatitis B surface antigen
HBV
hepatitis B virus
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Abbreviation
Term
HCV
hepatitis C virus
HCVAb
hepatitis C virus antibody
HIV
human immunodeficiency virus
HLA
human leukocyte antigen
HLA-DQA1 and 
HLA-DQB1 
human leukocyte antigen loci
HLA-DQ2.5
human leukocyte antigen loci encoded by HLA-DQA1*05 and 
HLA-DQB1*02 (homozygotes or heterozygotes) genotype
HLA-DQ8
human leukocyte antigen serotype with the HLA-DQ serotype group
HR
heart rate
HRT
hormone replacement therapy
hsCRP
high-sensitivity C-reactive protein
IB
Investigator’s Brochure
IBS
Irritable Bowel Syndrome
ICD
Informed Consent Document
ICH
International Council for Harmonisation of Technical Requirements 
for Pharmaceuticals for Human Use
ID
Identification
IEL
intraepithelial lymphocytes
IgA
immunoglobulin A
IgG
immunoglobulin G
IL-2
interleukin-2
IMP
investigational medicinal product
IND
Investigational New Drug
INR
international normalized ratio
IPAL
Investigational Product Accountability Log
IPM
investigational product manual
IRB
Institutional Review Board
IRR
infusion-related reaction
IRT
Interactive Response Technology
ISF
Investigator Site File
IV
intravenous(ly)
kel
elimination rate constant
KDIGO
Kidney Disease: Improving Global Outcomes
LBBB
left bundle branch block
LFT
liver function test
LSM
least-squares mean
MAD
multiple ascending dose
MedDRA
Medical Dictionary for Regulatory Activities
MHC
major histocompatibility complex
MQI
medically qualified individual
MTD
maximum tolerated dose
N/A
Not Applicable
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
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Abbreviation
Term
NCI
National Cancer Institute
NIMP
noninvestigational medicinal product
NOAEL
no observed adverse effect level
NTD
non-tolerated dose
OH
orthostatic hypotension
OTC
over the counter
PBMC
peripheral blood mononuclear cell
PBO
placebo
PD
pharmacodynamic(s)
PGIC
Patient Global Impression of Change
PGIS
Patient Global Impression of Severity
PI
Primary Investigator
PK
pharmacokinetic(s)
PO
by mouth; oral(ly)
PR
pulse rate
PRO
patient reported outcomes
PSSA
Pfizer’s Serious Adverse Event Submission Assistant
PT
Preferred Term; prothrombin time
QTc
corrected QT interval
QTcF
QTc corrected using Fridericia’s formula
qual
qualitative
Rand.
Randomization
RBC
red blood cell
RNA
ribonucleic acid
RR
respiratory rate
SAD
single ascending dose
SAE
serious adverse event
SAP
Statistical Analysis Plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SBP
systolic blood pressure
Scr
serum creatinine
Scys
serum cystatin C
SM
safety margin
SoA
schedule of activities
SOC
System Organ Class
SOP
standard operating procedure
SRSD
Single Reference Safety Document
SUSAR
Suspected Unexpected Serious Adverse Reactions
t½
terminal phase half-life
T bili
total bilirubin
TEAE
treatment-emergent adverse events
TPN
total parenteral nutrition
tTG
transglutaminase
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 133
Abbreviation
Term
Tmax
time to reach Cmax
ULN
upper limit of normal
US
United States
UTI
urinary tract infection
V
apparent volume of distribution
WBC
white blood cell
WOCBP
woman/women of childbearing potential
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KAN-101
Protocol KAN-101-02
Final Protocol Amendment 3, 30 Jan 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (01 April 2022)
Page 134
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