Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Phase: PHASE2
Conditions: Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Sponsor: AlloVir

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
Page 1 of 106 
 
CLINICAL STUDY PROTOCOL 
Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study 
to Assess the Safety and Efficacy of Viralym-M (ALVR105) Compared to 
Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV 
Infection and/or Disease, in High-Risk Patients After Allogeneic 
Hematopoietic Cell Transplant 
Investigational Product: ALVR105 (Viralym-M) 
Protocol Number: P-105-202 
IND: 15092 
EudraCT: N/A 
Sponsor: 
AlloVir Kirby Grove 
2925 Richmond Avenue, Suite 1200 
Houston, TX 77098 United States 
Telephone: 936-662-3626 
Fax: 979-289-7437 
FINAL PROTOCOL 
Version Number: 3.0 
Original Protocol: 13 July 2020 
Amendment 1: 27 October 2020 
Amendment 2:  07 Apr 2021 
Confidentiality Statement 
The information in this document is confidential and is not to be disclosed without the 
written consent of AlloVir except to the extent that disclosure would be required by law 
and for the purpose of evaluating and/or conducting a clinical study for AlloVir. You are 
allowed to disclose the contents of this document only to your Institutional Review Board 
or Independent Ethics Committee and study personnel directly involved with conducting 
this protocol. Persons to whom the information is disclosed must be informed that the 
information is confidential and proprietary to AlloVir and that it may not be further 
disclosed to third parties. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 7 of 106 
 
INVESTIGATOR AGREEMENT 
By signing below, I agree that: 
I have read this protocol, Phase 2, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to 
Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or 
Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant. I approve this 
document and I agree that it contains all necessary details for carrying out the study as 
described. I will conduct this study in accordance with the design and specific provision of 
this protocol and will make a reasonable effort to complete the study within the time 
designated. I will provide copies of this protocol and access to all information furnished by 
AlloVir to study personnel under my supervision. I will discuss this material with them to 
ensure they are fully informed about the study product and study procedures. I will let them 
know that this information is confidential and proprietary to AlloVir and that it may not be 
further disclosed to third parties. I understand that the study may be terminated or enrollment 
suspended at any time by AlloVir, with or without cause, or by me if it becomes necessary to 
protect the best interests of the study patients. 
I agree to conduct this study in full accordance with Food and Drug Administration 
Regulations, Institutional Review Board/Ethic Committee Regulations, and International 
Council for Harmonisation Guidelines for Good Clinical Practices and applicable national or 
regional regulations and guidelines. 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator’s Signature 
Date 
 
 
 
Investigator’s Printed Name 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 8 of 106 
 
 
TABLE OF CONTENTS 
 
Signature Page ............................................................................................................................... 2 
INVESTIGATOR AGREEMENT.................................................................................................. 7 
1. 
Protocol Summary ................................................................................................................. 16 
1.1. 
Synopsis ..................................................................................................................... 16 
1.2. 
Schema ....................................................................................................................... 21 
1.3. 
Schedules of Activities .............................................................................................. 22 
2. 
INTRODUCTION ................................................................................................................. 35 
2.1. 
Study Rationale .......................................................................................................... 35 
2.2. 
Background ................................................................................................................ 35 
2.2.1. 
Overview of Nonclinical Studies with ALVR105 ...................................... 36 
2.2.2. 
Overview of Clinical Studies with Virus-Specific T Cells ......................... 36 
2.3. 
Benefit/Risk Assessment ........................................................................................... 37 
2.3.1. 
Potential Benefits ........................................................................................ 37 
2.3.2. 
Potential Risks ............................................................................................. 37 
3. 
OBJECTIVES AND ENDPOINTS ....................................................................................... 39 
4. 
STUDY DESIGN .................................................................................................................. 42 
4.1. 
Overall Design ........................................................................................................... 42 
4.2. 
Scientific Rationale for Study Design ....................................................................... 44 
4.3. 
Justification for Dose ................................................................................................. 44 
4.4. 
End of Study Definition ............................................................................................. 45 
4.4.1. 
Meals and Dietary Restrictions ................................................................... 45 
5. 
STUDY POPULATION ........................................................................................................ 46 
5.1. 
Inclusion Criteria ....................................................................................................... 46 
5.2. 
Exclusion Criteria ...................................................................................................... 48 
5.3. 
Lifestyle Restrictions ................................................................................................. 49 
5.3.1. 
Caffeine, Alcohol, and Tobacco .................................................................. 49 
5.3.2. 
Activity ........................................................................................................ 49 
5.4. 
Screen Failures ........................................................................................................... 49 
6. 
STUDY INTERVENTION(S) AND CONCOMITANT THERAPY ................................... 50 
6.1. 
Study Intervention(s) Administered .......................................................................... 50 
6.1.1. 
Cell Line Selection ...................................................................................... 50 
6.1.2. 
Study Intervention Administration .............................................................. 51 
6.2. 
Preparation/Handling/Storage/Accountability ........................................................... 51 
6.2.1. 
Study Drug Preparation and Dispensing ..................................................... 52 
6.2.2. 
Storage and Accountability ......................................................................... 52 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 9 of 106 
 
6.3. 
Measures to Minimize Bias: Randomization and Blinding ....................................... 52 
6.4. 
Study Intervention Compliance ................................................................................. 53 
6.5. 
Dose Modification ..................................................................................................... 53 
6.5.1. 
Retreatment Criteria .................................................................................... 54 
6.6. 
Continued Access to Study Intervention after the End of the Study ......................... 54 
6.7. 
Treatment of Overdose .............................................................................................. 54 
6.8. 
Concomitant Therapy ................................................................................................ 54 
6.8.1. 
Excluded Medications and/or Procedures ................................................... 54 
6.8.2. 
Restricted Medications and/or Procedures .................................................. 55 
6.8.3. 
Documentation of Prior and Concomitant Medication Use ........................ 55 
6.8.4. 
Rescue Medication ...................................................................................... 55 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL ............................................................................. 56 
7.1. 
Discontinuation of Study Intervention....................................................................... 56 
7.1.1. 
Temporary Discontinuation ......................................................................... 56 
7.1.2. 
Rechallenge ................................................................................................. 56 
7.2. 
Participant Discontinuation/Withdrawal from the Study .......................................... 56 
7.3. 
Early Termination ...................................................................................................... 57 
7.4. 
Lost to Follow up ....................................................................................................... 57 
8. 
STUDY ASSESSMENTS AND PROCEDURES ................................................................. 58 
8.1. 
Study Periods ............................................................................................................. 58 
8.1.1. 
Pre-screening visit (optional) ...................................................................... 58 
8.1.2. 
Screening period .......................................................................................... 58 
8.1.3. 
Treatment period ......................................................................................... 59 
8.1.4. 
Follow-up period ......................................................................................... 59 
8.2. 
Efficacy Assessments ................................................................................................ 59 
8.2.1. 
Definitions and Determination of Viremia .................................................. 59 
8.2.2. 
Viral Load ................................................................................................... 59 
8.2.3. 
Resolution of Viral Infections ..................................................................... 59 
8.2.4. 
Quality of Life ............................................................................................. 60 
8.2.5. 
Virus-specific T Cell Assessment ............................................................... 60 
8.3. 
Infection Assessments ............................................................................................... 60 
8.3.1. 
Confirmatory Plasma Samples for Suspected Infection .............................. 61 
8.3.2. 
Samples When Initiating Anti-viral Therapy .............................................. 61 
8.4. 
Safety Assessments .................................................................................................... 61 
8.4.1. 
Physical Examinations ................................................................................ 61 
8.4.2. 
Vital Signs ................................................................................................... 61 
8.4.3. 
Electrocardiograms ...................................................................................... 62 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 10 of 106 
 
8.4.4. 
Clinical Safety Laboratory Assessments ..................................................... 62 
8.4.5. 
Pregnancy Testing ....................................................................................... 63 
8.4.6. 
Suicidal Ideation and Behavior Risk Monitoring ........................................ 63 
8.5. 
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety Reporting
 ................................................................................................................................... 63 
8.5.1. 
Time Period and Frequency for Collecting AE and SAE Information ....... 63 
8.5.2. 
Method of Detecting AEs and SAEs ........................................................... 64 
8.5.3. 
Follow-up of AEs and SAEs ....................................................................... 64 
8.5.4. 
Regulatory Reporting Requirements for SAEs ........................................... 64 
8.5.5. 
Pregnancy .................................................................................................... 65 
8.5.6. 
Cardiovascular and Death Events................................................................ 65 
8.5.7. 
Adverse Events of Special Interest .............................................................. 65 
8.6. 
Pharmacokinetics ....................................................................................................... 66 
8.7. 
Genetics and/or Pharmacogenomics .......................................................................... 66 
8.8. 
Biomarkers ................................................................................................................. 67 
8.9. 
Immunogenicity Assessments ................................................................................... 67 
8.10. Medical Resource Utilization and Health Economics ............................................... 67 
9. 
STATISTICAL CONSIDERATIONS .................................................................................. 68 
9.1. 
Statistical Hypotheses ................................................................................................ 68 
9.2. 
Sample Size Determination ....................................................................................... 68 
9.3. 
Analysis Populations ................................................................................................. 69 
9.4. 
Statistical Analyses .................................................................................................... 69 
9.4.1. 
General Considerations ............................................................................... 69 
9.4.2. 
Primary Efficacy Endpoint .......................................................................... 69 
9.4.3. 
Secondary Efficacy Endpoints .................................................................... 70 
9.4.4. 
Exploratory Endpoints ................................................................................. 71 
9.4.5. 
Safety Analysis ............................................................................................ 72 
9.4.6. 
Other Analyses ............................................................................................ 72 
9.5. 
Interim Analyses ........................................................................................................ 72 
9.5.1. 
Stopping Criteria ......................................................................................... 72 
10. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS......... 74 
10.1. Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ................... 74 
10.1.1. Regulatory and Ethical Considerations ....................................................... 74 
10.1.2. Financial Disclosure .................................................................................... 74 
10.1.3. Informed Consent Process ........................................................................... 75 
10.1.4. Data Protection ............................................................................................ 75 
10.1.5. Committee Structure.................................................................................... 75 
10.1.6. Dissemination of Clinical Study Data ......................................................... 76 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 11 of 106 
 
10.1.7. Data Quality Assurance ............................................................................... 76 
10.1.8. Source Documents ....................................................................................... 76 
10.1.9. Study and Site Start and Closure ................................................................. 77 
10.1.10. Publication Policy........................................................................................ 78 
10.2. Appendix 2: Clinical Laboratory Tests ...................................................................... 79 
10.3. Appendix 3: AEs and SAEs: Definitions and Procedures for Recording, Evaluating, 
Follow-up, and Reporting .......................................................................................... 82 
10.3.1. Definition of AE .......................................................................................... 82 
10.3.2. Definition of SAE ........................................................................................ 84 
10.3.3. Recording and Follow-Up of AE and/or SAE ............................................. 85 
10.3.4. Reporting of SAEs ...................................................................................... 87 
10.4. Appendix 4: Contraceptive and Barrier Guidance ..................................................... 89 
10.4.1. Definitions ................................................................................................... 89 
Woman of Nonchildbearing Potential (WONCBP) .............................................................. 89 
10.4.2. Contraception Guidance .............................................................................. 91 
10.5. Appendix 5: Graft Versus Host Disease .................................................................... 92 
10.6. Appendix 6: Cytokine Release Syndrome Scale ....................................................... 95 
10.7. Appendix 7: Monitoring for and Management of Cytokine Release Syndrome ....... 96 
10.8. Appendix 8: Endpoint Definitions ............................................................................. 98 
11. REFERENCES .................................................................................................................... 105 
 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 12 of 106 
 
 
LIST OF TABLES 
Table 1: 
Schedule of Activities–Pre-screening Period and Screening Period (All Cohorts) .... 22 
Table 2: 
Schedule of Activities – Treatment -- Period 1 for Patients ≥12 Years of Age (Week 1 
to 14, All Cohorts) ...................................................................................................... 26 
Table 3: 
Schedule of Activities – Treatment -- Period 1 for Patients < 12 Years of Age (Week 
1 to 14, All Cohorts) ................................................................................................... 30 
Table 4: 
Schedule of Activities: Short-Term Follow-Up--Period 2, All Ages (Weeks 18 to 26, 
All Cohorts) ................................................................................................................ 33 
Table 5: 
Protocol-Required Safety Laboratory Tests ................................................................ 80 
Table 6: 
MAGIC Criteria for Staging and Grading of Acute Graft Versus Host Disease ........ 92 
Table 7: 
Response Definitions for Acute Graft Versus Host Disease ...................................... 92 
Table 8: 
National Institutes of Health Global Severity of Chronic Graft Versus Host Disease 93 
Table 9: 
National Institutes of Health Response Determinations for Chronic Graft Versus Host 
Disease ........................................................................................................................ 93 
Table 10: ASTCT Consensus Cytokine Release Syndrome Grading Scale ............................... 95 
 
LIST OF FIGURES 
Figure 1: Study Flow Chart ........................................................................................................ 21 
 
 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 13 of 106 
 
LIST OF ABBREVIATIONS 
Abbreviation 
Definition or Term 
AdV 
Adenovirus 
AE 
Adverse event 
AESI 
Adverse event of special interest 
ALT 
Alanine aminotransferase 
ALVR105 
Viralym-M, ALVR-105 
AST 
Aspartate aminotransferase 
ASTCT 
American Society for Transplantation and Cell Therapy 
BKV 
BK virus 
CBC 
Complete blood count 
CFR 
Code of Federal Regulations 
CMV 
Cytomegalovirus 
CR 
Complete response 
CRF 
Case report form 
CRS 
Cytokine release syndrome 
CTCAE 
Common Terminology Criteria for Adverse Events 
CTL 
Cytotoxic T lymphocyte 
DNA 
Deoxyribonucleic acid 
DSMB 
Data Safety Monitoring Board 
EBV 
Epstein-Barr virus 
ECG 
Electrocardiogram 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
ET 
Early termination visit 
FDA 
Food and Drug Administration 
FSH 
Follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GGT 
Gamma-glutamyltransferase 
GI 
Gastrointestinal 
GVHD 
Graft versus host disease 
HBV 
Hepatitis B virus 
HC 
Hemorrhagic cystitis 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 14 of 106 
 
 
Abbreviation 
Definition or Term 
HCT 
Hematopoietic cell transplant 
HCV 
Hepatitis C virus 
HHV-6 
Human herpes virus 6 
HIV 
Human immunodeficiency virus 
HLA 
Human leukocyte antigen 
HRT 
Hormonal replacement therapy 
ICF 
Informed consent form 
ICH 
International Council on Harmonisation 
IEC 
Independent Ethics Committee 
IMP 
Investigational medicinal product 
IRB 
Institutional Review Board 
IRT 
Interactive response technology 
ITT 
Intent-to-Treat 
IV 
Intravenous, -ly 
IVIG 
Intravenous immunoglobulin 
JCV 
JC virus 
LLOQ 
Lower limit of quantitation 
MAGIC 
Mount Sinai Acute GVHD International Consortium 
MTD 
Maximum tolerated dose 
NCI 
National Cancer Institute 
NIMP 
Non-investigational medicinal product 
PBMC 
Peripheral blood mononuclear cell 
PML 
Progressive multifocal leukoencephalopathy 
PR 
Partial response 
Q 
Every 
qPCR 
Quantitative polymerase chain reaction 
QTL 
Quality tolerance limit 
RBC 
Red blood cell 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
SoA 
Schedule of Activities 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 15 of 106 
 
Abbreviation 
Definition or Term 
SSRE 
Sample size re-estimation 
SUSAR 
Suspected unexpected serious adverse reaction 
TEAE 
Treatment-emergent adverse event 
ULN 
Upper limit of normal 
VL 
Viral load 
VST 
Virus-specific T cell 
WOCBP 
Woman of childbearing potential 
WONCBP 
Woman of non-childbearing potential 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 16 of 106 
 
1. 
PROTOCOL SUMMARY 
1.1. 
Synopsis 
Protocol Title: Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to 
Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the 
Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk 
Patients After Allogeneic Hematopoietic Cell Transplant 
Protocol Number: P-105-202 
Rationale: 
This is a phase 2 study to evaluate the efficacy and safety of ALVR105 (also known as Viralym-
M and formerly known as ALVR-105) for the prevention of clinically significant adenovirus 
(AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr virus (EBV), human 
herpesvirus 6 (HHV-6) and JC virus (JCV) infections and/or disease in patients at high risk for 
these viruses following allogeneic hematopoietic cell transplant (HCT). In healthy, 
immunocompetent individuals, T cell immunity plays a central role in defending against viruses. 
In HCT recipients, the use of potent immunosuppressive regimens (and subsequent associated 
immunocompromise) leaves patients susceptible to severe viral infections. In approximately 
90% of allogeneic HCT patients, the suppressed immune system allows viruses that were 
previously in a latent, quiescent state to reactivate and more than 60% of allogeneic HCT 
patients experience a reactivation of more than one virus, including BKV, CMV, AdV, EBV and 
HHV-6 (Hill 2017). Viral infections result in devastating morbidities and have become leading 
etiologies for transplant-related mortality. There is no approved anti-viral agent that can prevent 
such potentially devastating single and/or multi-virus infection(s) as a single therapy. Some off-
label use of antiviral agents is associated with significant toxicities (notably myelosuppression 
and renal toxicity which might impede their use) and the emergence of drug-resistant viruses. 
As delay in the recovery of endogenous virus-specific T cells (VST) is clearly associated with 
viral reactivation and disease in these patients, cellular immunotherapy to restore viral-specific 
immunity has been investigated as a potential therapeutic option. The development of Viralym- 
M for the prevention and preemptive treatment of AdV, BKV, CMV, EBV, HHV-6, and/or JCV 
infections represents an unmet medical need. 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 17 of 106 
 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
1. To compare the efficacy of ALVR105 to 
placebo in the proportion of patients with 
clinically significant AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV infection 
and/or end-organ disease as determined 
by an independent, blinded Clinical 
Adjudication Committee (CAC) through 
Week 14 
1. The proportion of patients with 
clinically significant AdV, BKV, 
CMV, EBV, HHV-6, and/or JCV 
infection (defined as infection and/or 
end-organ disease as determined by 
an independent, blinded CAC) 
through Week 14 
Secondary 
1. To compare the efficacy of ALVR105 to 
placebo in time to onset of AdV, BKV, 
CMV, EBV, HHV-6, and/or JCV viremia 
over 14 weeks, in patients at high risk, 
following allogeneic HCT 
2. To compare the efficacy of ALVR105 to 
placebo in area under the curve (AUC) 
for cumulative viral load for AdV, BKV, 
CMV, EBV, HHV-6, and JCV over 14 
weeks 
3. To compare the efficacy of ALVR105 to 
placebo in incidence of clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease (excludes 
asymptomatic viremia) through Week 14 
4. To compare the efficacy of ALVR105 to 
placebo in the proportion of patients with 
clearance of AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV viremia in allogenic 
HCT patients with detectable viremia 
prior to the start of treatment 
5. To compare the efficacy of ALVR105 to 
placebo in the proportion of patients with 
clinically significant AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV infection 
and/or end-organ disease as determined 
by an independent, blinded CAC through 
Week 26 (the end of the 12-week safety 
1. Time to onset of AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV viremia 
over 14 weeks 
2. AUC for cumulative viral load for 
AdV, BKV, CMV, EBV, HHV-6, 
and JCV over 14 weeks 
3. Proportion of patients with clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease 
(excludes asymptomatic viremia) 
through Week 14 
4. Proportion of patients with clearance 
of AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV viremia by Week 8 in 
HCT patients with detectable viremia 
prior to the start of treatment 
5. Proportion of patients with clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease and/or 
end-organ disease as determined by 
an independent, blinded CAC 
through Week 26 (the end of the 12-
week safety follow-up period) 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 18 of 106 
 
Objectives 
Endpoints 
follow-up period) 
6. To compare the efficacy of ALVR105 to 
placebo in reducing hospitalization in 
HCT recipients through Week 26 
7. To compare the efficacy of ALVR105 to 
placebo in reducing non-relapse mortality 
in allogeneic HCT recipients through 
Week 26 
8. To compare the efficacy of ALVR105 to 
placebo on patient-reported quality of life 
through Week 26 
9. To assess the safety and tolerability of 
ALVR105 when administered to adult 
and pediatric patients at high-risk for 
AdV, BKV, CMV, EBV, HHV-6, and/or 
JCV following allogeneic HCT 
6. Total number of hospital days related 
to AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV infection or disease 
through Week 26 
7. Proportion of patients with AdV, 
BKV, CMV, EBV, HHV-6, and/or 
JCV disease-related mortality as 
determined by an independent, 
blinded CAC through Week 26 
8. Quality of life assessments, FACT- 
BMT, EQ-5D-5L, EQ-5D-Y, and 
EQ-5D-Y Proxy Version 1, through 
Week 26 
9.1. Incidence of overall non-relapse 
related mortality AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV disease 
related mortality as determined by 
an independent, blinded CAC 
9.2. Severity and incidence of acute 
GVHD 
9.3. Severity and incidence of chronic 
GVHD 
9.4. Severity and incidence of cytokine 
release syndrome 
9.5. Severity and incidence of clinically 
significant cytopenias 
9.6. Severity and incidence of renal 
dysfunction 
9.7. Effect on measures of engraftment 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 19 of 106 
 
Objectives 
Endpoints 
Exploratory 
1. To assess the development of anti-
viral- specific T cells 
2. To assess healthcare resource utilization 
through Week 26 
1. Detection of anti- AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV -specific T 
cells through Week 26. 
2.1. Hospital readmission rate related to 
AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV viremia/disease through 
Week 26 
2.2. Total days in the ICU through 
Week 26 
2.3. Proportion of patients requiring 
mechanical ventilation related to 
AdV, BKV, CMV, EBV, HHV-6 
and/or JCV infection or disease 
through Week 26 
2.4. Duration of anti-viral therapy 
(foscarnet, ganciclovir, cidofovir 
or other) due to viremia and/or 
disease through Week 26 
 
For the open-label portion of the study, similar endpoints will be analyzed. Additional details can 
be found in the Statistical Analysis Plan (SAP). 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 22 of 106 
 
 
1.3. 
Schedules of Activities 
Table 1: 
Schedule of Activities–Pre-screening Period and Screening Period (All Cohorts) 
Pre-screening 
Visita 
Pre-screening 
Perioda 
Screening Visitb 
Screening Periodb 
Study Week 
NA 
Weekly Visits 
Up to 6 weeks 
before Study Drug 
Administration 
Weekly after Screening Visit 
until Study Drug 
Administration 
Study Day 
NA 
NA 
May be from 
Day -42 to Study 
Drug 
Administration 
Day 
May be from Day -42 to Study 
Drug Administration Day 
Visit Window (Days) 
NA 
±3 
NA 
±3 
Study Procedures 
Informed consent/assentc 
X 
X 
I/E criteria 
Xd 
X 
Demographics 
X 
Medical historyd 
X 
Documentation of HLA 
typinge 
X 
Prior and concomitant 
medications including 
 
X 
X 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 23 of 106 
 
Pre-screening 
Visita 
Pre-screening 
Perioda 
Screening Visitb 
Screening Periodb 
 
Study Week 
NA 
Weekly Visits 
Up to 6 weeks 
before Study Drug 
Administration 
Weekly after Screening Visit 
until Study Drug 
Administration 
Study Day 
NA 
NA 
May be from 
Day -42 to Study 
Drug 
Administration 
Day 
May be from Day -42 to Study 
Drug Administration Day 
Visit Window (Days) 
NA 
±3 
NA 
±3 
conditioning regimen for 
HCT 
Adverse eventsf 
X 
X 
Complete physical 
examination 
X 
Weight and heightg 
X 
Vital signsh 
X 
12-lead ECG 
X 
Clinical labsi 
X 
Pregnancy testj 
X 
Testing for HIV, HCV, HBVk 
X 
 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 24 of 106 
 
 
Pre-screening 
Visita 
Pre-screening 
Perioda 
Screening Visitb 
Screening Periodb 
Study Week 
NA 
Weekly Visits 
Up to 6 weeks 
before Study Drug 
Administration 
Weekly after Screening Visit 
until Study Drug 
Administration 
Study Day 
NA 
NA 
May be from 
Day -42 to Study 
Drug 
Administration 
Day 
May be from Day -42 to Study 
Drug Administration Day 
Visit Window (Days) 
NA 
±3 
NA 
±3 
BKV, AdV, CMV, JCV, 
EBV, and HHV-6 viral loadl 
X 
X 
X 
Xm 
Abbreviations: AdV = adenovirus; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ; β-HCG = beta human chorionic gonadotropin; BKV 
= BK virus; CBC = complete blood count; CMV = cytomegalovirus; EBV = Epstein-Barr virus; ECG = electrocardiogram; GGT = gamma- 
glutamyltransferase; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; HHV-6 = human herpesvirus 6; 
HLA = human leukocyte antigen; I/E = inclusion and exclusion; JCV = JC virus; LFT = liver function test; NA = not applicable; PBMCs = 
peripheral blood mononuclear cells 
 
Note: Visits may be done via a home health visit as agreed with the Sponsor. Please see the Study Manual for more information. 
 
a Adult patients and pediatric patients ≥12 years old may participate in an optional pre-screening period that may begin up to 4 weeks prior to 
administration of conditioning for HCT and continue until there is a decision on whether to screen for the study. Viremia testing during pre-screening 
will begin after HCT and will continue weekly, if possible. Pre- screening is not required for eligibility. 
b The Screening Visit could occur any time between the day of HCT and up to 42 (+7) days post-HCT. When this visit occurs during this time period may 
vary by patient depending upon when the decision is made to participate in the study. 
c Prior to conducting any study-related activities, written informed consent/assent to participate in the study must be provided by the patient and/or 
patient’s guardian. The ICF for the pre-screening period is separate from the ICF that is signed at Screening Visit for study participation. 
d  To include CMV sero status of both patient and HCT donor 
e The HLA type of the patient and their HCT cell donor(s) will be obtained from the medical record. 
f Adverse events will be monitored and documented from signing of the ICF for study participation until study participation is complete. 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 25 of 106 
 
g Height and weight will be measured at screening. At later assessments during the Treatment Period, only weight will be assessed. 
h Includes body temperature, blood pressure, heart rate, O2 saturation, and respiration rate and will be measured after resting for 5 minutes.  
i Clinical laboratory assessments collected as part of standard of care may be used to fulfill these requirements. CBC must include differential and LFTs 
must include alkaline phosphatase, bilirubin (total and direct), GGT, AST, and ALT. Urinalysis must be performed. Laboratory safety evaluations 
(hematology, chemistry, and urinalysis) specified in Section 8.4.4 will be performed prior to study therapy initiation. These samples will be sent to the 
appropriate central laboratory(ies) following the procedure(s) described in the study manual(s). 
j For female patients, at Screening a β-HCG blood test will be performed. A urine pregnancy test will also be performed at the site prior to study 
therapy initiation (SoA for Treatment Period, Table 2). 
k Serum will be screened for HIV, HBV, and HCV antibodies with reflex nucleic acid testing of plasma. Medical records of previous testing in the last 
3-6 months may be used. 
l Viral loads of BKV, AdV, CMV, JCV, and HHV-6 in plasma and of EBV in PCMBs will be measured weekly for adult patients and pediatric patients 
≥ 12 years old after allogenic HCT conditioning during pre-screening period and screening period until treatment assignment, if possible. Pediatric 
patients < 12 years old will have only one blood draw during the Screening visit and will not have weekly blood draws during the screening period. Viral 
load testing should NOT be done on day of HCT during pre-screening. The results of the repeat analyses from the screening period must be available at 
the time of treatment assignment, unless the timing of the Screening Visit is 1 week or less before treatment administration. Results of central laboratory 
testing for viral load will be used for the purpose of determining eligibility/inclusion. 
m Adult patients and pediatric patients ≥ 12 years old only 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 26 of 106 
 
Table 2: 
Schedule of Activities – Treatment -- Period 1 for Patients ≥12 Years of Age (Week 1 to 14, All Cohorts) 
Treatment Period 
Time 
Period 
Treat 
ment 
Assign 
ment 
Study Drug 
Administration 
Day 
Wk 1 
Wk 
2 
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12 
Wk 
13 
Wk 
14 
Study Day 
1a 
8 
14 
21 
28 
35 
42 
49 
56 
63 
70 
77 
84 
91 
98 
Visit 
Window 
(Days) 
NAb 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±3 
Study 
Procedures 
Review of 
I/E criteria 
X 
Prior & 
concomitant 
medications 
as well as 
conditioning 
regimen for 
HCT 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse 
eventsc 
X 
X 
X 
X 
X 
X 
X 
X 
Physical 
examination 
d 
X 
X 
X 
X 
X 
X 
X 
X 
Weight 
X 
X 
X 
X 
X 
Vital signse 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead 
ECGf 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical 
labsg 
X 
X 
X 
X 
X 
X 
X 
X 
Pregnancy 
testh 
X 
X 
X 
X 
X 
X 
X 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 27 of 106 
 
Treatment Period 
Time 
Period 
Treat 
ment 
Assign 
ment 
Study Drug 
Administration 
Day 
Wk 1 
Wk 
2 
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12 
Wk 
13 
Wk 
14 
Study Day 
1a 
8 
14 
21 
28 
35 
42 
49 
56 
63 
70 
77 
84 
91 
98 
Visit 
Window 
(Days) 
NA 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±3 
Study 
Procedures 
BKV, AdV, 
CMV, JCV, 
and HHV-6 
viral loadi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
EBV 
PCMBsi 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Treatment 
Assignmentj 
X 
Virus- 
Specific T 
Cell 
Assessment
k 
X 
 
 
 
X 
X 
 
 
X 
 
 
X 
 
X 
Study 
treatment 
administrati
onl 
X 
X 
X 
X 
X 
X 
X 
Post 
infusion 
monitoring
m
X 
X 
X 
X 
X 
X 
X 
Infection 
assessmentn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 28 of 106 
 
 
Treatment Period 
Time 
Period 
Treat 
ment 
Assign 
ment 
Study Drug 
Administration 
Day 
Wk 1 
Wk 
2 
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12 
Wk 
13 
Wk 
14 
Study Day 
1a 
8 
14 
21 
28 
35 
42 
49 
56 
63 
70 
77 
84 
91 
98 
Visit 
Window 
(Days) 
NA 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±3 
Study 
Procedures 
Quality of 
Life (FACT- 
BMT, EQ- 
5D-5L, EQ- 
5D-Y, EQ- 
5D-Y Proxy 
Version 1)o 
X 
X 
X 
X 
X 
Abbreviations: AdV = adenovirus; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ; β-HCG = beta human chorionic gonadotropin; 
BKV = BK virus; CBC = complete blood count; CMV = cytomegalovirus; EBV = Epstein-Barr virus; ECG = electrocardiogram; ET = Early Termination 
Visit; GGT = gamma-glutamyl transferase; GVHD = graft versus host disease; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human 
immunodeficiency virus; HHV-6 = human herpesvirus 6; I/E = inclusion and exclusion; IVIG = intravenous immunoglobulin; JCV = JC virus; LFT = liver 
function test; NA = not applicable; PBMC = peripheral blood mononuclear cell; SoA = Schedule of Activities; VST = virus-specific T cell; Wk = week 
 
Note: Visits may be done via a home health visit as agreed with the Sponsor. Please see the Study Manual for more information. 
 
a Unless noted otherwise, Day 1 procedures must be performed within 72 hours prior to study treatment administration. 
b Dosing day may be up to +7 days with Sponsor approval. 
c Adverse event monitoring should include the collection of all adverse events through the treatment period in all patients, including those who have 
discontinued study treatment but are continuing in the study. For patients who have discontinued, only drug-related SAEs and SAEs leading to death will be 
collected until Week 26.d After treatment assignment, a targeted physical exam may be performed if a patient has any complaints. Post-HCT, the skin should 
be examined, even if the patient has no complaint, for evidence of rash/acute skin GVHD. 
e Includes body temperature, blood pressure, heart rate, O2 saturation, and respiration rate and will be measured after resting for 5 minutes. After treatment 
assignment, vital signs should be performed during and after infusions and if targeted physical examination is performed. 
f Performed within 1 hour after study treatment administration and at the end of study or early termination visit, which are listed in the SoA for the Short-
term Follow-up period (Table 3). 
gClinical laboratory assessments collected as part of standard of care may be used to fulfill these requirements. CBC must include differential and LFTs 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 30 of 106 
 
Table 3: 
Schedule of Activities – Treatment -- Period 1 for Patients < 12 Years of Age (Week 1 to 14, All Cohorts) 
Treatment 
Period 
Time 
Period 
Treat 
ment 
Assign 
ment 
Study Drug 
Administration 
Day 
Wk 
1 
Wk 
2 
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12 
Wk 
13 
Wk 
14 
Study Day 
1a 
8 
14 
21 
28 
35 
42 
49 
56 
63 
70 
77 
84 
91 
98 
Visit 
Window 
(Days) 
NAb 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±3 
Study 
Procedures 
Review of I/E 
criteria 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prior & 
concomitant 
medications as 
well as 
conditioning 
regimen for HCT 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
 
 
 
 
 
X 
Adverse 
eventsc 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
Physical 
examination 
d 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
Weight 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
Vital signse 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
12-lead 
ECGf 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Clinical labsg 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
Pregnancy testh 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
BKV, CMV, 
JCV, and 
HHV-6 viral 
loadi 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 31 of 106 
 
Treatment 
Period 
Time 
Period 
Treat 
ment 
Assign 
ment 
Study Drug 
Administration 
Day 
Wk 
1 
Wk 
2 
Wk 
3 
Wk 
4 
Wk 
5 
Wk 
6 
Wk 
7 
Wk 
8 
Wk 
9 
Wk 
10 
Wk 
11 
Wk 
12 
Wk 
13 
Wk 
14 
Study Day 
1a 
8 
14 
21 
28 
35 
42 
49 
56 
63 
70 
77 
84 
91 
98 
Visit 
Window 
(Days) 
NAb 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±5 
±3 
±3 
Study 
Procedures 
EBV PBMCsi 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
X 
X 
AdV viral load  
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Treatment 
Assignmentj 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Virus- Specific 
T Cell 
Assessmentk 
 
X 
 
 
 
X 
 
X 
 
 
X 
 
 
X 
 
X 
Study treatment 
administrati 
onl 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Post infusion 
monitoringm 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
X 
 
 
Infection 
assessmentn 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Quality of Life 
(FACT- BMT, 
EQ- 5D-5L, EQ- 
5D-Y, EQ- 
5D-Y Proxy 
Version 1)o 
X 
 
 
 
X 
 
 
 
X 
 
 
 
X 
 
X 
Abbreviations: AdV = adenovirus; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ; β-HCG = beta human chorionic gonadotropin; BKV = 
BK virus; CBC = complete blood count; CMV = cytomegalovirus; EBV = Epstein-Barr virus; ECG = electrocardiogram; ET = Early Termination Visit; GGT = 
gamma-glutamyl transferase; GVHD = graft versus host disease; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; 
HHV-6 = human herpesvirus 6; I/E = inclusion and exclusion; IVIG = intravenous immunoglobulin; JCV = JC virus; LFT = liver function test; NA = not 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 33 of 106 
 
rate, O2 saturation, respiration rate, and blood pressure, will be measured at the end of the infusion, and at 15, 30, 45, and 60 minutes after the end of the 
infusion. Patients must also remain on continuous pulse oximetry for ≥30 minutes after the end of the infusion. Post-infusion monitoring should be 
completed for all infusions of study treatment. 
n The infection assessment will be performed for all patients who require either treatment for disease or initiation of preemptive therapy during both the 
primary study period and the follow-up period through Week 26 (Section 8.3). It is very important to ensure that all procedures, as outlined in the SoA, are 
performed immediately prior to the initiation of treatment of viral diseases or initiation of preemptive therapy (ie, on the day anti-viral therapy is initiated). 
Most importantly, a plasma sample for AdV, BKV, CMV, HHV-6, and JCV and a PBMC sample for EBV for PCR testing at the central laboratory should 
be collected. Patients who develop viral infections will continue to be followed in the study and complete all remaining visits through Week 26. 
o Assessment of quality of life (using FACT-BMT, EQ-5D-5L, EQ-5D-Y, EQ-5D-Y Proxy Version 1questionnaires, as age-appropriate) should be completed prior to any 
study procedures at this visit. 
 
Table 4: 
Schedule of Activities: Short-Term Follow-Up--Period 2, All Ages (Weeks 18 to 26, All Cohorts) 
Study Week 
Week 18 
Week 22 
Week 26/ETa 
Study Day 
126 
154 
182 
Visit Window (Days) 
±3 
±3 
±3 
Study Procedures 
Prior & concomitant medications 
X 
X 
X 
Adverse eventsb 
X 
X 
X 
Weight 
X 
Vital signs 
X 
X 
X 
12-lead ECG 
X 
Clinical Labs 
X 
BKV, AdV, CMV, JCV, and HHV-6 viral loadc 
 
X 
X 
EBV PCMBsd 
 
X 
 
Virus-Specific T Cell assessmente 
X 
X 
X 
Infection assessmentf 
X 
X 
X 
Quality of Life (FACT-BMT and EQ-5D-5L, EQ-5D-Y, 
EQ-5D-Y Proxy Version 1)f 
X 
X 
X 
Abbreviations: AdV = adenovirus; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BKV = BK virus; CBC = complete blood count; 
CMV = cytomegalovirus; EBV = Epstein-Barr virus; ECG = electrocardiogram; ET = Early Termination Visit; GVHD = graft versus host disease; 
HHV-6 = human herpesvirus 6; JCV = JC virus; LFT = liver function test; PBMCs = peripheral blood mononuclear cells 
Note: Visits may be done via a home health visit as agreed with the Sponsor. Please see the Study Manual for more information. 
a The Early Termination Visit will be performed for all patients who are prematurely discontinued from the study up to Week 26. It is very important to 
ensure that all procedures are performed in such patients at this visit prior to discontinuing the patient from the trial. Most importantly, a plasma sample 
for AdV, BKV, CMV, HHV-6, and JCV and a PCMB sample for EBV for PCR testing at the central laboratory should be collected at this visit. 

AlloVir 
Clinical Study Protocol P-105-202 
 
Page 34 of 106 
 
b Adverse event monitoring should include the collection of all adverse events through follow-up in all patients, including those who have discontinued 
study treatment but are continuing in the study. Positive pregnancy and partner pregnancy information up to 90 days after last study drug administration 
will be collected. 
c Viral loads of AdV, BKV, CMV, HHV-6, and JCV in plasma and in PCMBs for EBV will be measured and evaluated at the central lab. Additional post- 
infusion samples may be collected if clinically indicated. If patient develops any clinically significant infection of AdV, BKV, CMV, EBV, HHV-6, or 
JCV at any point during the study periods, infection assessments should be completed prior to initiating standard of care therapy (see Section 8.3). 
d Patient peripheral blood mononuclear cells will be assessed for the presence of virus-reactive T cells using enzyme-linked immunospot. 
e The infection assessment will be performed for all patients who require either treatment for disease or initiation of preemptive therapy during both the 
primary study period and the follow-up period through Week 26 (Section 8.3). It is very important to ensure that all procedures, as outlined in the SoA, are 
performed immediately prior to the initiation of treatment of viral diseases or initiation of preemptive therapy (ie, on the day anti-viral therapy is initiated). 
Most importantly, a plasma sample for AdV, BKV, CMV, HHV-6, and JCV and a PCMB sample for EBV for PCR testing at the central laboratory should 
be collected. After developing an infection, such patients will continue to be followed in the study and complete all remaining visits through Week 26. 
f Assessment of quality of life (using FACT-BMT, EQ-5D-5L, EQ-5D-Y, and EQ-5D-Y Proxy Version 1questionnaires, as age-appropriate) should be 
completed prior to any study procedures at this visit. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 35 of 106 
 
2. 
INTRODUCTION 
ALVR105 (also known as Viralym-M and formerly known as ALVR-105) is a cellular therapy 
consisting of third-party, multivirus-specific T cells with specificity for adenovirus [AdV], BK 
virus [BKV], JC virus [JCV], human herpesvirus 6 [HHV- 6], Epstein-Barr virus [EBV], and 
cytomegalovirus [CMV] in 
 
 
AlloVir is developing ALVR105 (also known as ALVR105, formerly ALVR-105), a novel 
multivirus-specific cellular therapy, to treat or prevent a number of serious, virus-associated causes 
of morbidity and mortality after allogeneic HCT, including those caused by infection or 
reactivation with BKV (and the related polyomavirus JCV), CMV, HHV-6, EBV, and AdV. 
2.1. 
Study Rationale 
This is a phase 2 study to evaluate the efficacy and safety of ALVR105 for the prevention of 
clinically significant adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein-Barr 
virus (EBV), human herpesvirus 6 (HHV-6) and JC virus (JCV) infections and/or disease in 
patients at high risk for these viruses following allogeneic hematopoietic cell transplant (HCT). In 
healthy, immunocompetent individuals, T cell immunity plays a central role in defending against 
viruses. In HCT recipients, the use of potent immunosuppressive regimens (and subsequent 
associated immunocompromise) leaves patients susceptible to severe viral infections. In 
approximately 90% of allogeneic HCT patients, the suppressed immune system allows viruses that 
were previously in a latent, quiescent state to reactivate and more than 60% of allogeneic HCT 
patients experience a reactivation of more than one virus, including BKV, CMV, AdV, EBV and 
HHV-6 (Hill 2017). Viral infections result in devastating morbidities and have become leading 
etiologies for transplant-related mortality. There is no approved anti-viral agent that can prevent 
such potentially devastating single and/or multi-virus infection(s) as a single therapy. Some off-
label use of antiviral agents is associated with significant toxicities (notably myelosuppression and 
renal toxicity which might impede their use) and the emergence of drug- resistant viruses. 
As delay in the recovery of endogenous virus-specific T cells (VST) is clearly associated with viral 
reactivation and disease in these patients, cellular immunotherapy to restore viral-specific 
immunity has been investigated as a potential therapeutic option. The development of ALVR105 
for the prevention and preemptive treatment of AdV, BKV, CMV, EBV, HHV-6, and/or JCV 
infections represents an unmet medical need. 
2.2. 
Background 
During the period of immune recovery after allogeneic HCT, viral infections and reactivations, 
which are normally controlled by T cell immunity, are an important cause of morbidity and 
mortality. The risk for infection is dictated by a number of factors, including the degree of 
immunosuppression and the immune status of the donor. Reactivation of latent viruses such as 
CMV and BKV, or primary infection with a virus such as AdV, has become increasingly 
prominent. In a study at a large US HCT center, in approximately 90% of allogeneic HCT patients, 
the suppressed immune system allows viruses that were previously in a latent, quiescent state to 
reactivate and more than 60% of allogeneic HCT patients experience a reactivation of more than 
one virus, including BKV, CMV, AdV, EBV and HHV-6 (Hill 2017). In another recent study of 
infections following haploidentical allogeneic HCT, Slade, et al documented that 72% of patients 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 36 of 106 
 
experienced at least one severe viral infection (Slade 2017). Fifteen percent of patients developed 
CMV infection despite prophylaxis, and 19% developed BK virus-associated –hemorrhagic 
cystitis. One of 3 children is reported to have an AdV infection within 6 months following 
allogeneic HCT (Sedláček 2019). Progression to AdV disease is associated with significant 
morbidity and mortality rates of up to 50% (Zecca 2019). Similarly, Mulanovich and colleagues 
(2011) reported that, among patients receiving either cord blood or T-cell depleted transplants, viral 
infections were frequent and the most common cause of death in both groups. Even among T cell-
replete transplants using the post-cyclophosphamide protocol, Crocchiolo (2015) reported the 
incidence of viral infections to be 70%, with CMV and BKV being the most frequent and the most 
clinically threatening etiologies. The increased risk of mortality in the first 60 days post-transplant 
was approximately 18 times greater for patients with a CMV viral load ≥250 IU/ml (Green 2016). 
2.2.1. 
Overview of Nonclinical Studies with ALVR105 
Consistent with guidance from the United States Food and Drug Administration (FDA), AlloVir 
proceeded to clinical studies following completion of in vitro studies. No nonclinical animal 
pharmacology, pharmacokinetic, or toxicology studies of ALVR105 have been conducted or are 
planned. For additional information related to nonclinical studies with ALVR105, see the 
Investigator’s Brochure. 
2.2.2. 
Overview of Clinical Studies with Virus-Specific T Cells 
2.2.2.1. 
Results of the CHARMS Study with Third Party-Derived Multivirus-Specific T 
Cells, ALVR105 
To investigate the safety and clinical efficacy of ALVR105, a multivirus-specific T cell product 
reactive for BKV, AdV, HHV-6, EBV, and CMV generated from third-party, healthy, eligible 
donors, a Phase 1/2a clinical study was conducted in recipients of allogeneic HCT with drug- 
refractory infections with ≥1 of the 5 viruses targeted by ALVR105 (Tzannou, 2017). In this study, 
patients received a single IV infusion of 2×107 partially HLA-matched ALVR105 cells/m2, with the 
option to receive a second infusion after 4 weeks (actual range 14 days to >6 weeks) and additional 
infusions at biweekly intervals thereafter. Therapy with standard antiviral medications could be 
continued at the discretion of the treating physician (Tzannou, 2017). 
A total of 58 patients with drug-refractory infections following allogeneic HCT were infused with 
ALVR105 cell lines matched at 1 to 6 HLA antigens; 54 of these patients completed study 
treatment and the initial 28-day safety follow-up (the first 38 patients to complete the study are 
reported in Tzannou et al, 2017. Of the 71 total infections treated, 25 (35.2%) infections were BKV 
and 24 (33.8%) infections were CMV. Of the 58 patients who were treated (one of whom had 2 
courses of treatment), 48 patients were treated for a single virus, 10 patients were treated for 2 viral 
infections, and 1 patient was treated for infections by 3 different viruses. 
All infusions were well tolerated. None of the patients developed cytokine release syndrome 
(CRS). In the weeks after infusion, 1 patient developed recurrent Grade 3 gastrointestinal (GI) 
GVHD following rapid systemic corticosteroid taper, and 8 patients developed recurrent (n = 4) or 
de novo (n = 4) Grade 1 to 2 skin GVHD, which resolved with the administration of topical 
treatments (n = 7) and reinitiation of systemic corticosteroids after taper (n = 1). Between 3 and 
6 months after infusion, 2 patients experienced a flare of upper GI GVHD, which resolved after a 
brief systemic corticosteroid course. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 37 of 106 
 
Fifty-four (93%) of 58 evaluable patients had either a partial or complete clinical or virological 
response (either PR [defined as >50% reduction in viral load, or >50% improvement of clinical 
signs and symptoms] or CR [defined as return of the viral load to the normal range and resolution 
of clinical signs and/or symptoms]); no response was observed in 2 patients with AdV, and 1 each 
with CMV and HHV-6. Of note, all 23 patients with BKV-associated hemorrhagic cystitis (HC), 2 
of 3 patients with CMV colitis, the patient with CMV encephalitis (n = 1), the patients with AdV 
enteritis (n = 1) and AdV HC (n = 1), and 2 patients with HHV-6 encephalitis had improvement or 
resolution of symptoms within 6 weeks of treatment. In most responders (CR or PR), a post-
infusion increase in the frequency of circulating VSTs was detected. 
In addition to patients with post-HCT CMV, EBV, AdV, BKV, and HHV-6-associated infections, 
patients with JCV infections were also enrolled in this Phase 1/2 study. This decision was based on 
the identical nature of BKV and JCV T cell epitopes and on results of previous studies. More 
recently, it was demonstrated that partially HLA-matched third-party BKV-specific T cells could 
produce similar results in 3 immunosuppressed patients with progressive multifocal 
leukoencephalopathy (PML). Post-infusion, 2 patients experienced an alleviation of the clinical 
signs and imaging features of PML while the third patient had a reduction in JC viral load and 
stabilization of symptoms (Muftuoglu 2018) Given these promising results in the context of a 
complete lack of proven antiviral medications effective against JCV and the potentially devastating 
complications associated with JCV, patients with JCV infection will be included in the Phase 3 
study. 
2.3. 
Benefit/Risk Assessment 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of ALVR105 may be found in the Investigator’s Brochure. 
2.3.1. 
Potential Benefits 
A serious unmet medical need exists for patients experiencing viral infections and diseases such as 
AdV, BKV, CMV, EBV, HHV-6, and JCV following allogeneic HCT. Viral diseases post HCT are 
one of the highest causes of non-relapse morbidity and mortality in the post-transplant period. 
Despite the emergence of multiple anti-viral therapies, there is a major medical need due to 1) 
emergent resistance to therapy, 2) toxicity of available anti-virals, and 3) a subset of viruses: AdV, 
BKV, HHV-6, EBV, and JCV for which there are no approved and/or clearly effective therapies. 
The CHARMS study and other related clinical studies strongly suggest that ALVR105 is a safe and 
effective broad-spectrum therapy to treat commonly observed and severe virus-associated diseases 
after allogenic HCT. The results of these studies provide preliminary evidence of ALVR105's 
efficacy for multiple opportunistic viral infections in allogeneic HCT recipients, and its safety 
profile has the potential to be significantly better than that of standard, and inadequately effective, 
currently available antiviral therapy. 
2.3.2. 
Potential Risks 
ALVR105 primarily targets cells infected with AdV, BKV (and/or JCV), CMV, EBV, and/or 
HHV-6. The main risks of administration are inflammation at sites of existing disease or GVHD 
due to cross-reactivity with the recipient’s HLA antigens. Adverse events attributable to virus- 
specific T cell administration may potentially occur in a small percentage of the treated population. 
These can include both hematologic and non-hematologic effects, as reported in the CHARMS 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 38 of 106 
 
study. 
Studies of donor-derived virus-specific T cells suggest that virus-specific T cells do not persist in 
patients who receive methylprednisolone in doses ≥1 mg/kg/day. Therefore, if patients develop 
severe inflammatory reactions thought to be attributable to ALVR105, a therapeutic option is to 
administer methylprednisolone (1 to 2 mg/kg/day). In patients who develop skin rash or skin 
GVHD, excellent responses have been noted with the administration of topical steroids. 
As with other biological therapies delivered by IV infusion, the side effects of ALVR105 infusion 
include allergic reactions (anaphylaxis), decreased oxygenation, nausea/vomiting, arrhythmia, and 
hypotension. 
A detailed breakdown of the timepoints and blood volumes to be collected during the course of this 
study is provided in the Laboratory Manual. 
In order to minimize the volume of blood collected during the study trial, the blood volume of 
individual samples has been reduced to the maximum extent feasible wherever possible. This has 
been performed in a manner that is expected to maintain the scientific integrity of the study and 
related data, while minimizing the risks to the patients. 
In order to minimize the volume of blood collected during the study, especially for pediatric 
patients, the blood volume of individual samples has been reduced to the maximum extent feasible 
wherever possible. For pediatric patients < 12 years of age, collection of blood samples for the 
evaluation of viral load for all six viruses (AdV, BKV, CMV, EBV, and/or HHV-6, and JCV) is 
limited to every other week and blood volume is sufficient for testing only AdV viremia in the 
other weeks. Pediatric patients also do not participate in pre-screening blood samples. This 
reduction in volume of blood collection has been done in a manner that is expected to maintain the 
scientific integrity of the study while minimizing the risks to patients. For maximum blood draw 
volumes, see the Laboratory Manual. 
For the collection of other study-related material from the patients, there are no invasive procedures 
that are required for the study conduct beyond those that are used as part of the routine and 
standard clinical care of patients undergoing allogeneic HCT. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 39 of 106 
 
3. 
OBJECTIVES AND ENDPOINTS 
Objectives 
Endpoints 
Primary 
1. To compare the efficacy of ALVR105 
to placebo in the proportion of patients 
with clinically significant AdV, BKV, 
CMV, EBV, HHV-6, and/or JCV 
infection and/or end-organ disease as 
determined by an independent, 
blinded Clinical Adjudication 
Committee (CAC) through Week 14 
1. The proportion of patients with 
clinically significant AdV, BKV, 
CMV, EBV, HHV-6, and/or JCV 
infection (defined as infection and/or 
end-organ disease as determined by 
an independent, blinded CAC) 
through Week 14 
Secondary 
1. To compare the efficacy of 
ALVR105 to placebo in time to onset 
of AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV viremia over 14 weeks, in 
patients at high risk, following 
allogeneic HCT 
2. To compare the efficacy of 
ALVR105 to placebo in area under 
the curve (AUC) for cumulative 
viral load for AdV, BKV, CMV, 
EBV, HHV-6, and JCV over 14 
weeks 
3. To compare the efficacy of ALVR105 
to placebo in incidence of clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease (excludes 
asymptomatic viremia) through Week 
14 
4. To compare the efficacy of ALVR105 
to placebo in the proportion of patients 
with clearance of AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV viremia in 
allogeneic HCT patients with 
detectable viremia prior to the start of 
treatment 
1. Time to onset of AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV viremia 
over 14 weeks 
2. AUC for cumulative viral load for 
AdV, BKV, CMV, EBV, HHV-6, and 
JCV over 14 weeks 
3. Proportion of patients with clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease 
(excludes asymptomatic viremia) 
through Week 14 
4. Proportion of patients with clearance 
of AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV viremia by Week 8 in 
HCT patients with detectable viremia 
prior to the start of treatment 
5. To compare the efficacy of ALVR105 
to placebo in the proportion of patients 
with clinically significant AdV, BKV, 
CMV, EBV, HHV-6, and/or JCV 
5. Proportion of patients with clinically 
significant AdV, BKV, CMV, EBV, 
HHV-6, and/or JCV disease and/or 
end-organ disease as determined by an 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 40 of 106 
 
Objectives 
Endpoints 
infection and/or end-organ disease as 
determined by an independent, blinded 
CAC through Week 26 (the end of the 
12-week safety follow- up period) 
6. To compare the efficacy of ALVR105 
to placebo in reducing hospitalization 
in HCT recipients through Week 26 
7. To compare the efficacy of ALVR105 
to placebo in reducing non-relapse 
mortality in allogeneic HCT recipients 
through Week 26 
8. To compare the efficacy of 
ALVR105 to placebo on patient- 
reported quality of life through Week 
26 
9. To assess the safety and tolerability of 
ALVR105 when administered to adult 
and pediatric patients at high-risk for 
AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV following allogeneic HCT 
independent, blinded CAC through 
Week 26 (the end of the 12-week safety 
follow- up period) 
6. Total number of hospital days related 
to AdV, BKV, CMV, EBV, HHV-6, 
and/or JCV infection or disease 
through Week 26 
7. Proportion of patients with AdV, 
BKV, CMV, EBV, HHV-6, and/or 
JCV disease-related mortality as 
determined by an independent, blinded 
CAC through Week 26 
8. Quality of life assessments, FACT- 
BMT, EQ-5D-5L, EQ-5D-Y, and EQ-
5D-Y Proxy Version 1, through Week 
26 
9.1. Incidence of overall non-relapse 
related mortality AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV disease 
related mortality as determined by an 
independent, blinded CAC 
9.2. Severity and incidence of acute 
GVHD 
9.3. Severity and incidence of chronic 
GVHD 
9.4. Severity and incidence of cytokine 
release syndrome 
9.5. Severity and incidence of clinically 
significant cytopenias 
9.6. Severity and incidence of renal 
dysfunction 
9.7. Effect on measures of engraftment 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 41 of 106 
 
Objectives 
Endpoints 
Exploratory 
1. To assess the development of 
antiviral-specific T cells 
2. To assess healthcare resource 
utilization through Week 26 
1. Detection of anti- AdV, BKV, CMV, 
EBV, HHV-6, and/or JCV - specific T 
cells through Week 26. 
2.1. Hospital readmission rate related to 
AdV, BKV, CMV, EBV, HHV- 6, 
and/or JCV viremia/disease through 
Week 26 
2.2. Total days in the ICU through 
Week 26 
2.3. Proportion of patients requiring 
mechanical ventilation related to 
AdV, BKV, CMV, EBV, HHV-6 
and/or JCV infection or disease 
through Week 26 
2.4. Duration of anti-viral therapy 
(foscarnet, ganciclovir, cidofovir or 
other) due to viremia and/or disease 
through Week 26 
 
For the open-label portion of the study, similar endpoints will be analyzed. Additional details can 
be found in the Statistical Analysis Plan (SAP). 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 45 of 106 
 
actual doses administered in the CHARMS study demonstrated that, on average, patients who 
weighed ≥40 kg received 
 per infusion (n = 45). For patients <40 kg, the dose will 
be  
 
 
4.4. 
End of Study Definition 
The end of the study (“study completion”) is defined as the date of the last protocol-specified 
visit/assessment (including telephone contact) for the last patient in the study. 
A participant is considered to have completed the study if he/she has completed all phases of the 
study including the Week 26 visit. 
Patients will be asked to have a follow up telephone call at approximately 52 weeks (12 months) 
after the end of study visit to collect mortality data. 
4.4.1. 
Meals and Dietary Restrictions 
This section is not applicable. 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 46 of 106 
 
5. 
STUDY POPULATION 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria 
Patients must meet all the following criteria in order to be eligible to participate in the study: 
 
Age 
1. Be ≥1 year of age at the day of screening. 
Type of Participant and Disease Characteristics  
 
 
 
 
 
 
 
For OL Cohort 
4. May meet viremia criterion for either Cohort A or Cohort B 
For OL Cohort, 
 
5. Be within 15 and 42 (+7) days of receiving a first allogeneic HCT at the time of 
treatment assignment and have demonstrated engraftment with an absolute 
neutrophil count >500/µL.  
6. High-risk: Patients meeting one or more of the following criteria at the time of treatment 
assignment: 
o Human leukocyte antigen (HLA)-related (sibling) donor with at least one mismatch 
at one of the following three HLA-gene loci: HLA-A, -B or -DR 
o Haploidentical donor 
o Unrelated donor with at least one mismatch at one of the following four HLA-gene 
loci: HLA-A, -B, -C and -DRB1 
o Use of umbilical cord blood as stem cell source 
o Ex vivo graft manipulation resulting in T cell depletion 
o Lymphocyte count <180/mm3 and/or cluster of differentiation 4 (CD4) T cell count 
<50/mm3  
 
Sex 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 47 of 106 
 
7. Male and/or female 
a. 
Male participants: 
Male participants are eligible to participate if they agree to the following during the 
study intervention period and for at least 90 days after the last dose of study 
intervention: 
• Refrain from donating sperm PLUS, either: 
• Be abstinent from heterosexual 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 contraception /barrier as detailed below 
• Agree to use a male condom and should also be advised of the benefit for a 
female partner to use a highly effective method of contraception as a condom 
may break or leak when having sexual intercourse with a woman of 
childbearing potential (WOCBP) who is not currently pregnant 
b. Female participants: 
• A female participant is eligible to participate if she is not pregnant 
or breastfeeding, and 1 of the following conditions applies: 
• Is a woman of non-childbearing potential (WONCBP) as defined 
in Section 10.4.1 
OR 
• Is a WOCBP and using an acceptable contraceptive method as described in 
Section 10.4.2 during the study intervention period and for at least 90 days 
after the last dose of study intervention. The Investigator should evaluate the 
potential for contraceptive method failure (eg, noncompliance, recently 
initiated) in relationship to the first dose of study intervention. 
• A WOCBP must have a negative highly sensitive serum pregnancy test 
within 14 days before the first dose of study intervention, see Section 8.4.5. 
• Additional requirements for pregnancy testing during and after 
study intervention are located in Section 8.4.5. 
• 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. 
 
 
Informed Consent 
8. Willing and able to provide written informed consent as described in Section 10.1.3 to 
participate in the study, or a parent or legal guardian is willing and able to provide 
written informed consent and the potential pediatric patient is able to provide assent in a 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 48 of 106 
 
manner approved by the Institutional Review Board (IRB) and local regulations 
 
5.2. 
Exclusion Criteria 
Patients who meet any of the following criteria will be excluded from participation in the study: 
Medical Conditions 
1. Has a history of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease 
within 6 months prior to treatment assignment 
2. Has evidence of AdV, BKV, CMV, EBV, HHV-6, and/or JCV viremia for more 
than 3 viruses, from a central or local laboratory at any time during Screening prior 
to treatment assignment 
3. Evidence of active Grade >2 acute GVHD (for additional information on acute 
GVHD grading and severity, see Appendix 5 [Section 10.5] or CRS Appendix 6 
[Section 10.6], respectively). 
4. Presence of non-minor uncontrolled or progressive bacterial or fungal infections (ie, 
evidence of bacteremia, fungemia, disseminated, and/or organ-specific infection not 
well controlled by present therapies) 
5. Presence of progressive, uncontrolled viral infections with evidence of end organ disease 
6. Known history or current (suspected) diagnosis requiring treatment of 
CRS associated with the administration of peptides, proteins, and/or 
antibodies 
7. Evidence of encephalopathy at screening 
8. Relapse of primary malignancy other than minimal residual disease. 
 
Prior/Concomitant Therapy 
9. Donor lymphocyte infusion performed within 21 days prior to randomization 
10. Received within 7 days prior to treatment assignment any of the following: ganciclovir, 
valganciclovir, foscarnet, acyclovir (at doses >3200 mg PO per day or >25 mg/kg IV 
per day), valacyclovir (at doses >3000 mg PO per day), famciclovir (at doses >1500 mg 
PO per day) 
11. Received any investigational antiviral agent/biologic therapy within 30 days prior to 
screening or plans to receive during the study any of the following: cidofovir, CMV 
hyper-immune globulin, or any investigational CMV antiviral agent/biologic therapy. 
12. Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose 
>0.5 mg/kg/day) within 7 days prior to screening 
13. Prior therapy with antithymocyte globulin, alemtuzumab (Campath-1H), or other 
immunosuppressive T cell-targeted monoclonal antibodies within 28 days of treatment 
assignment 
14. Receipt of mechanical ventilation of any type, within 1 month prior to the 
administration of ALVR105 (unless related to airway control) 
15. Undergoing dialysis at any time during the screening period 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 49 of 106 
 
 
Prior/Concurrent Clinical Study Experience 
16. Received a previous allogeneic HCT (Note: Receipt of a previous autologous HCT 
is acceptable) 
17. Receipt of another investigational antiviral vaccine or treatment during the study 
or within 28 days prior to treatment assignment or study treatment administration 
Diagnostic assessments 
18. Aspartate aminotransferase or alanine aminotransferase serum levels >5 × the upper 
limit of normal (ULN) or direct bilirubin serum levels >2 × the ULN reference per 
central laboratory. 
19. Presence of any progressive, uncontrolled viral infections (ie, evidence of viremia, 
dissemination, and/or organ-specific infection not well controlled by present 
therapies) not targeted by ALVR105. 
Other Exclusions 
20. Pregnant, breastfeeding, or planning to become pregnant during the study 
21. Has a history or current evidence of any condition, therapy, lab abnormality, or other 
circumstance that might confound the results of the study, interfere with the patient's 
participation for the full duration of the study, or would be put at undue risk as judged 
by the Investigator, such that it is not in the best interest of the patient to participate in 
this study 
5.3. 
Lifestyle Restrictions 
This section is not applicable. 
5.3.1. 
Caffeine, Alcohol, and Tobacco 
This section is not applicable. 
5.3.2. 
Activity 
This section is not applicable. 
5.4. 
Screen Failures 
Screen failures are defined as participants who consent to participate in the clinical study but are 
not randomized into the clinical study. A minimal set of screen failure information is required to 
ensure transparent reporting of screen failure participants to meet the Consolidated Standards of 
Reporting Trials publishing requirements and to respond to queries from regulatory authorities. 
Minimal information includes demography, screen failure details, eligibility criteria, and any 
serious adverse events (SAEs). 
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened in consultation with the Medical Monitor. 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 54 of 106 
 
6.5.1. 
Retreatment Criteria 
No further treatment is planned after the last dose of ALVR105 (or placebo) after Week 14. 
Patients will continue in the study for evaluation of safety, efficacy, and other endpoints after Week 
14 for an additional 3 months (through Week 26).  
6.6. 
Continued Access to Study Intervention after the End of the Study 
No further treatment will be provided after the last dose of ALVR105 (or placebo) after Week 14. 
However, patients will continue in the study for evaluation of safety, efficacy, and other endpoints 
for an additional 12 weeks (3 months). 
6.7. 
Treatment of Overdose 
For this study, any dose of ALVR105 greater than any dose over the IRT assigned dose (2x107 for 
patients < 40 kg or 4×107 cells for patients ≥ 40 kg) within a 24-hour period (±1 hour) will be 
considered an overdose. 
As there is no antidote, the Sponsor does not recommend specific treatment for an overdose. In the 
event of an overdose, the Investigator should: 
• Contact the Medical Monitor immediately. 
• Evaluate the patient to determine, in consultation with the Medical Monitor, 
whether study treatment should be interrupted or whether the dose should be 
reduced. 
• Closely monitor the patient for any AE/SAE and laboratory abnormalities until the 
next dosing day. 
• Document the quantity of the excess dose as well as the duration of the overdose. 
6.8. 
Concomitant Therapy 
Clinically available (ie, not investigational) antiviral agents prescribed for other infections, such as 
foscarnet and ganciclovir to treat CMV, are allowed. Data on their use will be collected along with 
other concomitant medications. 
6.8.1. 
Excluded Medications and/or Procedures 
All patients may receive available supportive therapy with approved treatments. Investigators 
should try to maintain stable treatment to the extent possible.  
Receipt of other investigational antiviral treatments (eg, brincidofovir or anti-BK virus monoclonal 
antibodies) within 28 days prior to randomization and throughout the duration of the study is 
prohibited. 
Treatment with supportive regimen therapies, other intravesicular agents for the control of bleeding 
(including, but not limited to, aminocaproic acid), antispasmodics, treatment for pain control 
(including opioids), and blood product transfusion support are permitted. Analgesic use will be 
collected on a daily basis. Clinically available (ie, not investigational) antiviral agents prescribed 
for other infections are allowed. Use of cidofovir or brincidofovir (eg, for the treatment of AdV) 
must be discussed with the Medical Monitor prior to initiation. All instances of the use of any 
antiviral agents during the study will be recorded in the eCRF (including the drug name, dose, and 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 55 of 106 
 
duration of treatment). 
T cell ablative therapies, such as antithymocyte globulin, alemtuzumab (Campath-1H), or other 
immunosuppressive T cell-targeted monoclonal antibodies, are prohibited during the course of the 
study. Daily doses of corticosteroids exceeding 0.5 mg/kg prednisone (or equivalent) are prohibited 
during the course of the study. Should patients require medically a higher dose of steroids, no 
further study drug will be administered until the steroids are tapered to a dose equivalent of 0.5 
mg/kg prednisone (or equivalent) or less. 
6.8.2. 
Restricted Medications and/or Procedures 
6.8.2.1. 
Supportive care 
The following supportive care measures are permitted: 
• Analgesics 
• Narcotics 
• IV hydration 
• Antispasmodics 
• Transfusion of red blood cells (RBCs) 
• Transfusion of platelets 
• Transfusion of fresh frozen plasma 
All supportive care measures must be documented in the patient study records and the eCRF. 
6.8.3. 
Documentation of Prior and Concomitant Medication Use 
All medications, including GVHD prophylaxis, used within 30 days before screening will be 
recorded. All concomitant medications and concurrent therapies will be documented as indicated in 
the SoA (Section 1.3). Dose, route, unit frequency of administration, indication for administration, 
and dates of medication will also be captured in source documents and on the appropriate eCRF. 
6.8.4. 
Rescue Medication 
This section is not applicable. 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 56 of 106 
 
7. 
DISCONTINUATION OF STUDY INTERVENTION AND 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
7.1. 
Discontinuation of Study Intervention 
The following criteria do not necessitate withdrawal from the study, but do render the patient 
ineligible to receive any additional infusions of study treatment: 
1. Development of irreversible, life-threatening, Grade 3 to 4 acute GVHD within 6 weeks, 
or a Grade 3 to 4 non-hematologic AE within 4 weeks from last ALVR105 dose that is 
considered related to study treatment administration. If this occurs, the patient’s toxicities 
will be followed until resolution or until the patient’s participation in the study ends. 
2. Receipt of any other hematopoietic stem cell product. 
3. Receipt of therapy for relapse of the patient’s primary malignancy. 
4. Occurrence of Grade 3 or 4 CRS that persists beyond 72 hours. If this occurs, the patient’s 
toxicities will be followed until resolution or until the patient’s participation in the study 
ends. 
If any of the above criteria are met, every effort should be made to keep the patient in the study and 
continue follow-up. 
7.1.1. 
Temporary Discontinuation 
Temporary discontinuation will be allowed only if discussed with and approved by the Medical 
Monitor. 
7.1.2. 
Rechallenge 
This section is not applicable. 
7.2. 
Participant Discontinuation/Withdrawal from the Study 
Participation of a patient in this clinical study may be discontinued for any of the following 
reasons: 
• The patient withdraws consent 
• The patient requests discontinuation from the study for any reason 
• Occurrence of any medical condition or circumstance that exposes the patient to 
substantial risk and/or does not allow the patient to adhere to the requirements of 
the protocol 
• Any SAE, clinically significant AE, severe laboratory abnormality, intercurrent illness, 
or other medical condition that indicates to the Investigator that continued participation 
is not in the best interest of the patient 
• Pregnancy 
• Requirement for prohibited concomitant medication 
• Patient failure to comply with protocol requirements or study-related procedures 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 57 of 106 
 
• Termination of the study by the Sponsor or the regulatory authority 
If the participant withdraws consent for disclosure of future information, the Sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. 
If a participant withdraws from the study, he/she may request destruction of any samples taken and 
not tested, and the Investigator must document this in the site study records. 
Patients who are discontinued from the study for any reason will not be replaced. Patients who 
discontinue the study early, should have the procedures scheduled for the Week 26/ET visit 
completed at the time of discontinuation from the study. The reason for patient withdrawal must be 
documented in the eCRF. 
7.3. 
Early Termination 
The ET Visit will be performed for all patients who are prematurely discontinued up to Week 26 
from the study; however, patients who decide only to discontinue therapy early will continue to 
complete trial procedures as per protocol. It is very important to ensure that all procedures, as 
outlined in the SoA ET visit, are performed in such patients at this visit prior to discontinuing the 
patient from the trial. Most importantly, a plasma sample for AdV, BKV, CMV, HHV-6, and JCV 
and a PCMB sample for EBV for PCR testing at the central laboratory should be collected at this 
visit. 
7.4. 
Lost to Follow up 
A participant will be considered lost to follow-up if he or she 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 and counsel the participant on the importance of maintaining the assigned 
visit schedule and ascertain whether or not 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, he/she will be considered to 
have withdrawn from the study. 
Discontinuation of specific sites or of the study as a whole are handled as part of Appendix 1 in 
Section 10.1.9. 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 58 of 106 
 
8. 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and their timing are summarized in the SoA. Protocol waivers 
or exemptions are not allowed. 
• Immediate safety concerns should be discussed with the Sponsor immediately upon 
occurrence or awareness to determine if the participant should continue or 
discontinue study intervention. 
• 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. 
• Procedures conducted as part of the participant’s routine clinical management (eg, 
blood count) and obtained before signing of the informed consent form (ICF) may be 
utilized for screening or baseline purposes provided the procedures met the protocol-
specified criteria and were performed within the time frame defined in the SoA. 
• Results (eg, Safety/Laboratory/analyte) that could unblind the study will not be 
reported to investigative sites or other blinded personnel until the study has been 
unblinded. 
• The amount of blood collected from each adult (≥18 years) and pediatric patient over 
the duration of the study are described in the Laboratory Manual. The maximum 
amount of blood collected, including any extra assessments that may be required, will 
not exceed 10.5 mL/kg or 550 mL, whichever is smaller, over any eight week period for adult 
patients.  
• For pediatric patients, blood sampling requirements for the study have been minimized 
by reducing the volume per sample collected (where possible), and by omitting 
collection at certain timepoints. 
• Repeat or unscheduled samples may be taken for safety reasons or for technical 
issues with the samples. 
8.1. 
Study Periods 
8.1.1. 
Pre-screening visit (optional) 
A pre-screening visit will be completed if possible at least 1 week prior to HCT. A separate ICF for 
pre-screening will be obtained.  
8.1.2. 
Screening period 
Screening of potential eligible patients may begin as soon as the day of HCT and within 42 (+7) 
days after transplantation. Patients will have plasma samples tested for AdV, BKV, CMV, HHV-6, 
and JCV viremia and PBMCs for EBV viremia using PCR assays weekly during the screening 
period. Patients should be tested at the first assessment during Screening by the central laboratory 
for AdV, BKV, CMV, EBV, HHV-6, and JCV viremia using PCR assays for each virus. Patients 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 60 of 106 
 
the lower limit of quantification (LLOQ) and complete resolution of clinical signs and symptoms 
as determined by the Investigator and the CAC (see Appendix 7, Section 10.7). 
8.2.4. 
Quality of Life 
Quality of life will be measured using the FACT-BMT and the age-appropriate version of the EQ-
5D at times indicated in Section 1.3. The FACT-BMT was designed to measure the QoL in patients 
undergoing bone marrow transplantation. It combines the general Functional Assessment of Cancer 
Therapy (FACT-G), assessing physical well-being, social/family well- being, emotional well-being 
and functional well-being, with the Bone Marrow Transplantation Sub-scale (BMTS) to measure 
BMT-specific concerns (McQuellon 1997). 
The EQ-5D is a group of instruments that was developed to assess patient-reported health-related 
QoL (EuroQol Group 1990). The EQ-5D-5L includes the EQ-5D descriptive system and the EQ 
visual analog scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, 
self-care, usual activities, pain/discomfort, and anxiety/depression. In the EQ-5D-5L, each 
dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and 
extreme problems. The patient is asked to indicate his or her health state by checking the box next 
to the most appropriate statement in each of the 5 dimensions. The versions used in children have 3 
responses to each question instead of 5. 
In this study, the EQ-5D-5L will be used for individuals ≥12 years of age, the EQ-5D-Y for 
children 8 to 11 years of age, and the EQ-5D-Y Proxy Version 1 for children ≤7 years of age. Data 
for children <4 years of age will also be collected using the EQ-5D-Y Proxy Version 1, but these 
results will be analyzed separately from the results for children 4 to 7 years of age. 
The EQ-5D-5L, the EQ-5D-Y, and the EQ-5D-Y Proxy Version 1 include the EQ Visual Analog 
Scale (VAS). The EQ VAS records the patient’s self-rated health on a vertical visual analog scale, 
where the endpoints are labeled “The best health you can imagine” and “The worst health you can 
imagine.” 
Quality of life measures should be completed as indicated in the SoA and prior to any study 
procedures at the visit. 
8.2.5. 
Virus-specific T Cell Assessment 
Patient peripheral blood mononuclear cells will be assessed for the presence of each of the viral- 
specific virus-reactive T cells using enzyme-linked immunospot. See Section 1.3. 
8.3. 
Infection Assessments 
Infection assessments will be performed for all patients who, in the opinion of the Investigator, 
might meet the criteria described in Appendix 8, Section 10.8. It is very important to ensure that all 
procedures, as outlined in the SoA, are performed for infection assessment immediately prior to the 
initiation of treatment of viral diseases or initiation of preemptive therapy (ie, on the day anti- viral 
therapy is initiated). 
A symptom checklist should be completed in the infection assessment eCRF. 
Patients will continue to be followed in the study and complete all remaining visits through Week 
26 as outlined in the SoA. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 61 of 106 
 
8.3.1. 
Confirmatory Plasma Samples for Suspected Infection 
Most importantly, a plasma sample for AdV, BKV, CMV, HHV-6, and JCV, and a PBMC sample 
for EBV for PCR testing at the central laboratory should be collected. Should confirmatory test 
results from the central laboratory not be available within the timeframe that the Investigator 
wishes to initiate anti-viral therapy, the Investigator may use a positive local laboratory test result 
to make the decision. Whenever it is deemed clinically necessary to use a local laboratory, a 
plasma sample should also be collected and sent to the central laboratory. 
8.3.2. 
Samples When Initiating Anti-viral Therapy 
If antiviral therapy is to be initiated, it is mandatory to send a plasma sample for AdV, BKV, CMV, 
HHV-6, and JCV and a PBMC sample for EBV for DNA PCR testing to the central laboratory 
immediately prior to (ie, on the day of) initiating treatment for AdV, BKV, CMV, EBV, HHV-6, or 
JCV disease or preemptive therapy in ALL instances. As clinically indicated, stool, urine, and/or 
CSF samples should be collected for AdV, BKV, CMV, EBV, HHV-6, and JCV and sent to the 
central laboratory as feasible (see Appendix 8, Section 10.8.)  
When local laboratory test results are used for initiating anti-viral therapy, two plasma (and PBMC 
for EBV) samples for PCR testing must be sent to the central laboratory. The first sample must be 
collected immediately prior to (ie, on the day of) initiating anti-viral therapy. The second sample 
must be collected 48-72 hours after initiating anti-viral therapy. The local laboratory result must 
also be reported in such instances. 
8.4. 
Safety Assessments 
Planned time points for all safety assessments are provided in the SoA (Section 1.3). 
8.4.1. 
Physical Examinations 
• A complete physical examination will include, at a minimum, assessments of 
the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems and 
skin. 
• Investigators should pay special attention to clinical signs related to previous 
serious illnesses. 
• Physical examinations will be performed and height and weight will be collected as 
indicated in Section 1.3. The complete physical examination will be overseen by either 
the Investigator or a Sub-Investigator who is a physician. New abnormal physical 
examination findings must be documented and will be followed by a physician or 
other qualified staff at the next scheduled visit. 
 
8.4.2. 
Vital Signs 
• Temperature, pulse rate, O2 saturation, respiratory rate, and blood pressure will 
be assessed. 
• Blood pressure and pulse measurements will be assessed with a completely 
automated device. Manual techniques will be used only if an automated device is not 
available. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 62 of 106 
 
• Vital signs will be measured in a semi-supine position after 5 minutes rest and will 
include temperature, systolic and diastolic blood pressure, and pulse and respiratory 
rate. 
8.4.3. 
Electrocardiograms 
• Single 12-lead electrocardiograms (ECG) will be obtained as outlined in the SoA 
(see Section 1.3) using an ECG machine that automatically calculates the heart rate 
and measures PR, QRS, QT, and QTc (corrected using Fredericia’s and Bazett’s methods) 
intervals. 
• The ECG will be performed within 1 hour after study treatment administration on 
visits with administration of study therapy. 
 
8.4.4. 
Clinical Safety Laboratory Assessments 
• See Appendix 2 (Section 10.2) for the list of clinical laboratory tests to be performed 
and to the SoA (Section 1.3) for the timing and frequency. 
• Samples will be sent to the appropriate central laboratory(ies) following the 
procedure(s) described in the lab manual. 
• The Investigator must review the laboratory report, document this review, and record any 
clinically significant changes occurring during the study as an AE. The laboratory reports 
must be filed with the source documents. 
• Abnormal laboratory findings associated with the underlying disease are not 
considered clinically significant unless judged by the Investigator to be more severe 
than expected for the participant's condition. 
• All laboratory tests with values considered clinically significantly abnormal during 
participation in the study or within 28 days 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 Medical Monitor. 
o If clinically significant 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. 
o All protocol-required laboratory tests, as defined in Appendix 2 (Section 10.2), 
must be conducted in accordance with the laboratory manual and the SoA (Section 
1.3). 
o If laboratory values from non-protocol specified laboratory tests performed at 
the institution’s local laboratory require a change in participant management or 
are considered clinically significant by the Investigator (eg, SAE or AE or dose 
modification), then the results must be recorded. 
• Assessment of blood cell counts and renal function will be monitored for anti-
viral toxicity 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 63 of 106 
 
8.4.5. 
Pregnancy Testing 
• A serum pregnancy test will be performed at screening for all female patients of 
childbearing potential. Prior to treatment assignment, a urine pregnancy test will be 
performed. If the urine pregnancy test result is negative, the patient will be eligible for 
treatment assignment and the remainder of the Day 1 testing/procedures will be 
performed. If the urine pregnancy result is positive, the patient must not be assigned to 
treatment and should reflex to a β-HCG blood test before screen failing. See Section 
1.3 
• A urine pregnancy test will be performed prior to each treatment for female patients 
who are of childbearing potential. See Section 1.3. 
8.4.6. 
Suicidal Ideation and Behavior Risk Monitoring 
This section is not applicable. 
8.5. 
Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Safety 
Reporting 
• The definitions of AEs and SAEs can be found in Appendix 3 (Section 10.3). 
• The definitions of unsolicited and solicited AEs can be found in Appendix 3 
(Section 10.3). 
• AEs will be reported by the participant (or, when appropriate, by a caregiver, surrogate, 
or the participant's legally authorized representative). 
• 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 for following up all AEs OR AEs that are serious, considered related to the 
study intervention or study procedures, or that caused the participant to discontinue the 
study intervention or study (see Section 7). 
• 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 
4 (Section 10.6). 
8.5.1. 
Time Period and Frequency for Collecting AE and SAE Information 
• All AEs and SAEs will be collected at the time points specified in the SoA (Section 
1.3) from signing of informed consent until study participation is complete. 
• Medical occurrences that begin before treatment assignment but after obtaining informed 
consent/assent will be recorded as Medical History/Current Medical Conditions, not as 
AEs. 
• All SAEs will be recorded and reported to the Sponsor or designee immediately and 
under no circumstance should this exceed 24 hours, as indicated in Appendix 3 
(Section 10.3). The Investigator will submit any updated SAE data to the Sponsor 
within 24 hours of it being available. 
• Investigators are not obligated to actively seek information on AEs or SAEs after 
conclusion of the study participation. However, if the Investigator learns of any SAE, 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 64 of 106 
 
including a death, at any time after a participant has been discharged from the study, 
and he/she considers the event to be reasonably related to the study intervention or 
study participation, the Investigator must promptly notify the Sponsor. 
8.5.2. 
Method of Detecting AEs and SAEs 
Care will be taken not to introduce bias when detecting AEs and/or SAEs. Open-ended and non-
leading verbal questioning of the participant is the preferred method to inquire about AE 
occurrences. 
8.5.3. 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each participant 
at subsequent visits/contacts. All SAEs, and AEs of special interest (as defined in Section 8.5.7), 
will be followed until resolution, stabilization, the event is otherwise explained, or the participant is 
lost to follow-up (as defined in Section 7.4). Further information on follow- up procedures is 
provided in Appendix 4 (Section 10.6). 
8.5.4. 
Regulatory Reporting Requirements for SAEs 
• Prompt notification by the Investigator to the Sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities towards 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, Institutional 
Review Boards (IRB)/Independent Ethics Committees (IEC), and Investigators. 
• An Investigator who receives an Investigator safety report describing an SAE or 
other specific safety information (eg, summary or listing of SAEs) from the Sponsor 
will review and then file it along with the Investigator’s Brochure and will notify the 
IRB/IEC, if appropriate, according to local requirements. 
• Investigator safety reports must be prepared for suspected unexpected serious 
adverse reactions (SUSAR) according to local regulatory requirements and Sponsor 
policy and forwarded to Investigators as necessary. 
8.5.4.1. 
Expedited Reporting 
The Sponsor/designee will report all relevant information about SUSARs that are fatal or life- 
threatening as soon as possible to the FDA, applicable competent authorities in all the Member 
States concerned, and the Central Ethics Committee, and in any case no later than 7 days after 
knowledge by the Sponsor/designee of such a case. Relevant follow-up information will 
subsequently be communicated within an additional 8 days. 
All other SUSARs will be reported to the FDA, applicable competent authorities concerned, and 
the Central Ethics Committee concerned as soon as possible but within a maximum of 15 days of 
first knowledge by the Sponsor/designee. 
The Sponsor/designee will also report any additional expedited safety reports required in 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 65 of 106 
 
accordance with the timelines outlined in country-specific legislation. 
The Sponsor/designee will also inform all Investigators as required per local regulation. 
The requirements above refer to the requirements relating to the investigational medicinal product. 
8.5.5. 
Pregnancy 
• Details of all pregnancies in female participants will be collected after the start of 
study intervention and until 90 days after the last dose of study intervention. 
• If a pregnancy is reported, the Investigator will record pregnancy information on the 
appropriate form and submit it to the Sponsor within 24 hours of learning of the 
[female participant or female partner of male participant (after obtaining the necessary signed 
informed consent from the female partner)] pregnancy. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy for medical reasons will be 
reported as an AE or SAE. 
• Abnormal pregnancy outcomes (eg, spontaneous abortion, fetal death, stillbirth, 
congenital anomalies, ectopic pregnancy) are considered SAEs and will be reported 
as such. 
• The patient will be followed to determine the outcome of the pregnancy. The Investigator 
will collect follow-up information on the participant and the neonate and the information 
will be forwarded to the Sponsor. 
• Any post-study pregnancy-related SAE considered reasonably related to the 
study intervention by the Investigator will be reported to the Sponsor as 
described in Section 8.5.4. While the Investigator is not obligated to actively 
seek this information in former study participants, he or she may learn of an 
SAE through spontaneous reporting. 
• Any female participant who becomes pregnant while participating in the study 
will discontinue study intervention. 
 
8.5.6. 
Cardiovascular and Death Events 
This section is not applicable. 
8.5.7. 
Adverse Events of Special Interest 
Adverse events of special interest (AESIs) include infusion-related AEs, acute and chronic GVHD, 
and CRS. Criteria for acute and chronic GVHD and CRS can be found in Appendix 5 (Section 
10.5) and Appendix 6 (Section 10.6), respectively. 
8.5.7.1. 
Special Situation Reports 
Special situation reports include reports of overdose, misuse, abuse, medication error, and reports 
of adverse reactions associated with product complaints. 
• Overdose: Refers to the administration of a quantity of a medicinal product given per 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 67 of 106 
 
8.8. 
Biomarkers 
• Biomarkers are not evaluated in this study. 
8.9. 
Immunogenicity Assessments 
• Immunogenicity assessments are not evaluated in this study. 
8.10. 
Medical Resource Utilization and Health Economics 
• Hospital length of stay and re-admission rates are assessed in this study. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 72 of 106 
 
9.4.5. 
Safety Analysis 
All safety data will be summarized by cohort, stratum,
 
. For Cohort OL, results will be presented by stratum and overall, 
as all patients in Cohort OL receive only ALVR105.. Categorical endpoints will be summarized 
using the number and percentage of patients within each category. Continuous endpoints will be 
summarized descriptively with summary statistics (number of non-missing observations, arithmetic 
mean, standard deviation, median, minimum, and maximum). 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities. A treatment 
emergent adverse event (TEAE) is defined as an AE with onset or worsening on or after the first 
dose of study treatment. TEAEs will be summarized by System Organ Class and Preferred Term 
and further by severity (according to the National Cancer Institute [NCI] Common Terminology 
Criteria for Adverse Events [CTCAE] v5.0) and by relationship to study treatment. The incidence 
of SAEs will be summarized. 
The incidence of AEs of special interest (AESIs), including acute and chronic GVHD and CRS, 
and their corresponding exact binomial 95% confidence intervals will be presented. 
Descriptive statistics will be provided for continuous clinical laboratory, vital sign, and ECG data 
for both the raw data and change from baseline. Abnormal laboratory results will be graded 
according to NCI CTCAE v5.0, if applicable. Shift tables, presenting the 2-way frequency 
tabulation for baseline and the worst post-baseline value according to the NCI CTCAE grade, will 
be provided for selected clinical laboratory tests. 
9.4.6. 
Other Analyses 
The baseline demographics of participants, such as age and gender, etc., will be summarized by 
cohort and treatment group using frequency counts and percentages for categorical variables and 
descriptive statistics for continuous variables. Continuous variables will be analyzed using a two- 
sided, two-sample t-test to test for a difference in means between treatment groups. Categorical 
variables will be analyzed using a two-sided, Fisher’s Exact Test to test for a difference in 
proportions between treatment groups. 
9.5. 
Interim Analyses 
A review by the DSMB will be done when approximately 30 patients in the OL Cohort have 
completed 30 days of treatment. At this time an assessment of benefit, risk, and process will be 
done, and study optimization will be considered. 
 
  
A sample size re-estimation (SSRE) and futility analyses will be performed.  
The planned interim analyses will be described in greater detail in a separate document. 
9.5.1. 
Stopping Criteria 
9.5.1.1. 
Stopping Criteria for Individual Patients 
As GVHD and CRS are theoretical safety concerns associated with administration of third-party 
allogeneic T cells, the incidence and severity of GVHD and CRS will be monitored during the 
study. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 73 of 106 
 
No patients will be permitted to receive subsequent infusions of ALVR105 or placebo if: 
1. They develop irreversible, life-threatening, Grade 3 to 4 acute GVHD within 6 weeks, or 
a Grade 3 to 4 non-hematologic AE within 4 weeks from last ALVR105 dose that is 
considered related to study treatment administration. If this occurs, the patient’s toxicities 
will be followed until resolution or until the patient’s participation in the study ends, 
2. Receive any other hematopoietic stem cell product, 
3. Receive therapy for relapse of the patient’s primary malignancy, 
4. Develop Grade 3 or 4 CRS that persists beyond 72 hours.  
  
9.5.1.2. 
Stopping Criteria for the Study 
Treatment assignment will be halted if 3 patients experience SAEs that meet the following criteria: 
• 
CTCAE Grade 3 
• 
Considered related by the Investigator 
• 
Occur during the Treatment Period following the initial dose 
• 
Cannot be reasonably attributed to the patient’s underlying disease, other 
medical condition, or concomitant medications 
If this occurs, treatment assignment will not resume until there has been a thorough review of all 
safety data to date and concluded that it is safe for the study to continue. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 74 of 106 
 
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: 
o Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
o Applicable International Council on Harmonisation (ICH) Good Clinical 
Practice (GCP) Guidelines 
o Applicable laws and regulations 
• The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be submitted to an IRB/IEC by the Investigator 
and reviewed and approved by the IRB/IEC before the study is initiated. 
• Any amendments to the protocol will require IRB/IEC 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: 
o Providing written summaries of the status of the study to the IRB/IEC annually 
or more frequently in accordance with the requirements, policies, and 
procedures established by the IRB/IEC 
o Notifying the IRB/IEC of SAEs or other significant safety findings as required 
by IRB/IEC procedures 
o Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 Code of Federal Regulations (CFR), ICH guidelines, the 
IRB/IEC, European regulation 536/2014 for clinical studies (if applicable), 
European Medical Device Regulation 2017/745 for clinical device research (if 
applicable), and all other applicable local regulations 
 
10.1.2. 
Financial Disclosure 
Investigators and sub-Investigators 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. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 75 of 106 
 
10.1.3. 
Informed Consent Process 
• The Investigator or his/her representative will explain the nature of the study to the 
participant or their legally authorized representative and answer all questions 
regarding the study. 
• Participants must be informed that their participation is voluntary. Participants or their 
legally authorized representative will be required to sign a statement of informed 
consent that meets the requirements of 21 CFR 50, local regulations, ICH guidelines, 
Health Insurance Portability and Accountability Act (HIPAA) requirements, where 
applicable, and the IRB/IEC or study center. 
• The medical record must include a statement that written informed consent was 
obtained before the participant was enrolled in the study and the date the written 
consent was obtained. The authorized person obtaining the informed consent must also 
sign the ICF. 
• Participants must be re-consented to the most current version of the ICF(s) during 
their participation in the study. 
• A copy of the ICF(s) must be provided to the participant or their legally 
authorized representative. 
10.1.4. 
Data Protection 
• Participants will be assigned a unique identifier by the Sponsor. Any participant 
records or datasets that are transferred to the Sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred. 
• The participant must be informed that his/her 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 who will be required to give consent for their 
data to be used as described in the informed consent 
• The participant must be informed that his/her medical records may be examined 
by Clinical Quality Assurance auditors or other authorized personnel appointed 
by the Sponsor, by appropriate IRB/IEC members, and by inspectors from 
regulatory authorities. 
 
10.1.5. 
Committee Structure 
10.1.5.1. Clinical Adjudication Committee 
The CAC will determine the definition of AdV, BKV, CMV, EBV, HHV-6, or JCV end organ 
disease (see CAC charter). 
10.1.5.2. Data Safety Monitoring Board 
A review by the DSMB will be done when approximately 30 patients have completed 30 days of 
treatment and throughout the study as indicated in the DSMB charter (see DSMB charter). 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 76 of 106 
 
10.1.6. 
Dissemination of Clinical Study Data 
Data generated by this study must be available for inspection by the FDA, the Sponsor or their 
designee, applicable foreign health authorities, and the IRB/IEC as appropriate. Patients or their 
legal representatives may request their medical information be given to their personal physician or 
other appropriate medical personnel responsible for their welfare. 
Patient medical information obtained during the study is confidential and disclosure to third parties 
other than those noted above is prohibited. 
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 Study Manual. 
• The Investigator must permit study-related monitoring, audits, IRB/IEC review, 
and regulatory agency inspections and provide direct access to source data 
documents. 
• Quality tolerance limits (QTLs) will be pre-defined to identify systematic issues that can 
impact participant safety and/or reliability of study results. These pre-defined parameters 
will be monitored during the study and important deviations from the QTLs and remedial 
actions taken will be summarized in the clinical study report. 
• Monitoring details describing strategy (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, remote, or on-site 
monitoring) are provided in the Monitoring Plan. 
• The Sponsor or designee is responsible for the data management of this study 
including quality checking of the data. 
• The Sponsor assumes accountability for actions delegated to other individuals 
(eg, Contract Research Organizations). 
• Records and documents, including signed ICFs, pertaining to the conduct of this study 
must be retained by the Investigator for 5 years after study completion unless local 
regulations or institutional policies require a longer retention period. No records may 
be destroyed during 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. 
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’s site. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 77 of 106 
 
• Data reported on the CRF or entered in the eCRF that are transcribed 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. 
• Definition of what constitutes source data can be found in the Study Manual. 
• The Investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF. 
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, legible, complete, 
original, attributable, 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, and all 
applicable regulatory requirements. 
 
10.1.9. 
Study and Site Start and Closure 
10.1.9.1. First Act of Recruitment 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
The first act of recruitment is the activation of the first open site in the Interactive Response System 
(IRS) and will be the study start date. 
10.1.9.2. Study/Site Termination 
The Sponsor or 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. 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, provided there is reasonable cause and 
sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the Sponsor or Investigator may include but are not 
limited to: 
For study termination: 
• Discontinuation of further study intervention development  
For site termination: 
• Failure of the Investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the Sponsor's procedures, or GCP guidelines 
• Inadequate or no recruitment (evaluated after a reasonable amount of time) of 
participants by the Investigator 
• Total number of participants included earlier than expected 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 78 of 106 
 
If the study is prematurely terminated or suspended, the Sponsor shall promptly inform the 
Investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization(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 
10.1.10. 
Publication Policy 
Following completion of the study, the data may be considered for publication in a scientific 
journal and/or for reporting at a scientific meeting. Each Investigator is obligated to keep data 
pertaining to the study confidential. The Investigator must consult with the Sponsor before any 
study data are submitted for publication. The Sponsor reserves the right to deny publication rights 
until mutual agreement on the content, format, interpretation of data in the manuscript, and journal 
selected for publication are achieved. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 79 of 106 
 
10.2. 
Appendix 2: Clinical Laboratory Tests 
• The tests detailed in Table 5: Protocol-Required Safety Laboratory Tests will be performed by 
the central laboratory. 
• Local laboratory results are only required in the event that the central laboratory results 
are not available in time for either study intervention administration and/or response 
evaluation. If a local sample is required, it is important that the sample for central 
analysis is obtained at the same time. Additionally, if the local laboratory results are 
used to make either a study intervention decision or response evaluation, the results 
must be recorded. 
• Protocol-specific requirements for inclusion or exclusion of participants are detailed 
in Section 5 of the protocol. 
• Additional tests may be performed at any time during the study as determined 
necessary by the Investigator or required by local regulations. 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 80 of 106 
 
Table 5: 
Protocol-Required Safety Laboratory Tests 
Clinical Chemistry Panel (Central Laboratory) 
Alanine aminotransferase 
Albumin 
Alkaline phosphatase 
Amylase 
Aspartate aminotransferase 
Bicarbonate 
Blood urea nitrogen 
Calcium 
Chloride 
Creatine kinase 
Creatinine 
Direct bilirubin Gamma-glutamyl transferase 
Glucose 
Inorganic phosphorus 
Lactate dehydrogenase 
Lipase 
Potassium 
Sodium 
Total bilirubin 
Total protein 
Uric acid 
 
Hematology (Central Laboratory) 
Hematocrit 
Hemoglobin 
Platelets 
Red blood cell count 
White blood cell count and differential [1] 
1. 
Manual microscopic review is performed only if white blood cell count and/or differential values are out of reference 
range. 
 
Viral Load in Blood and Urine (Central Laboratory) 
Adenovirus 
BK virus 
Cytomegalovirus 
Epstein-Barr virus 
Human herpesvirus 6 
JC virus 
When viral load determination is performed in the laboratory, residual viral deoxyribonucleic acid (DNA) will be stored for 
potential viral sequencing and genotyping in the event of recurrent infection. 
Viral load determination at screening may be performed at a local or central laboratory for the purpose of determining 
eligibility/inclusion. If the results from the local laboratory are used for determination of eligibility/inclusion, an additional 
pre-randomization sample for viruria testing must be collected for assay at the central laboratory. These results do not have to 
be available at the time of randomization or study treatment infusion. Additional post-infusion samples may be collected, as 
clinically indicated. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 81 of 106 
 
Urinalysis (Local Laboratory) 
Bilirubin 
Blood 
Glucose 
Ketones 
Leukocyte esterase 
Nitrite pH 
Protein 
Specific gravity 
Urobilinogen 
Stool Specimen (Central Laboratory) 
Adenovirus 
Cytomegalovirus 
If a stool specimen is clinically indicated, stool samples will also be sent to the central laboratory for research purposes. 
 
Cerebrospinal Fluid Sample (Central Laboratory) Cytomegalovirus
 
Human 
herpesvirus 6 JC virus 
If a cerebrospinal fluid sample is clinically indicated, samples will also be sent to the central laboratory for research purposes 
as feasible. Cerebrospinal fluid samples required for clinical care of the patient take precedence over these research-related 
evaluations. 
 
Other Laboratory Assessments 
Serum pregnancy test [1] 
Urine pregnancy test [1] 
Follicle-stimulating hormone [2] 
Peripheral blood mononuclear cells (PBMCs) 
and plasma [3] 
Serology (HIV antibody, hepatitis B surface antigen [HBsAg], and hepatitis C virus antibody) 
along with confirmatory tests if requested 
Virus Specific T-cell Assessment 
1. 
For female patients of childbearing potential only. A serum (β-human chorionic gonadotropin) pregnancy test will be 
performed at screening. A urine pregnancy test will be performed prior to dosing for female patients who are of 
childbearing potential.  
2. 
Follicle-stimulating hormone will be tested at screening for women of nonchildbearing potential who are 
postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause. 
3. 
At each time-point indicated in the SoAs (Section 1.3), blood will be collected into a cell separation tube and processed 
to generate a PBMC fraction and a plasma fraction. Genomic DNA will be extracted from the PBMC fraction. The 
genomic DNA from PBMC and plasma fractions will be cryopreserved for potential future evaluation of virus-specific 
T cell persistence (PBMC fraction) and for future evaluation of cytokines and/or other humoral markers of 
inflammation/immune function (plasma fraction). 
 
Investigators must document their review of each laboratory safety report. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 89 of 106 
 
10.4. 
Appendix 4: Contraceptive and Barrier Guidance 
10.4.1. 
Definitions 
Woman of Childbearing Potential (WOCBP) 
Women in the following categories are considered WOCBP (fertile): 
1. Following menarche 
2. From the time of menarche until becoming post-menopausal unless permanently 
sterile (see below) 
• A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. 
o A high follicle-stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the absence 
of 12 months of amenorrhea, confirmation with more than one FSH measurement 
is required. 
o Females on HRT and whose menopausal status is in doubt will be required to use 
one of the non-estrogen hormonal highly effective contraception methods if they 
wish to continue their HRT during the study. Otherwise, they must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment. 
• Permanent sterilization methods (for the purpose of this study) include: 
o Documented hysterectomy 
o Documented bilateral salpingectomy 
o Documented bilateral oophorectomy 
o For individuals with permanent infertility due to an alternate medical cause other 
than the above, (eg, Mullerian agenesis, androgen insensitivity, gonadal 
dysgenesis), Investigator discretion should be applied to determining study entry. 
Note: Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview. 
• If fertility is unclear (eg, amenorrhea in adolescents or athletes) and a menstrual 
cycle cannot be confirmed before first dose of study intervention, additional 
evaluation should be considered. 
 
Woman of Nonchildbearing Potential (WONCBP) 
Women in the following categories are considered WONCBP: 
3. Premenopausal female with permanent infertility due to one of the following: 
a. Documented hysterectomy 
b. Documented bilateral salpingectomy 
c. Documented bilateral oophorectomy 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 90 of 106 
 
d. For individuals with permanent infertility due to an alternate medical cause other 
than the above, (eg, Mullerian agenesis, androgen insensitivity, gonadal 
dysgenesis), Investigator discretion should be applied to determining study entry. 
Note: Documentation can come from the site personnel’s review of the participant’s 
medical records, medical examination, or medical history interview. 
4. Postmenopausal female 
a. A postmenopausal state is defined as no menses for 12 months without an 
alternative medical cause. 
i. A high follicle stimulating hormone (FSH) level in the postmenopausal range 
may be used to confirm a postmenopausal state in women not using hormonal 
contraception or hormonal replacement therapy (HRT). However, in the 
absence of 12 months of amenorrhea, confirmation with more than one FSH 
measurement 
>40 IU/L or mIU/mL is required. 
ii. Females on HRT and whose menopausal status is in doubt must discontinue 
HRT to allow confirmation of postmenopausal status before study enrollment. 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 91 of 106 
 
10.4.2. 
Contraception Guidance 
CONTRACEPTIVES ALLOWED DURING THE STUDY INCLUDE: 
Highly Effective Methods That Have Low User Dependency Failure rate of <1% per year when used 
consistently and correctly. 
• Implantable progestogen-only hormone contraception associated with inhibition of ovulationb 
• Intrauterine device (IUD) 
• Intrauterine hormone-releasing system (IUS) b 
• Bilateral tubal occlusion 
• Azoospermic partner (vasectomized or due to a medical cause) 
Azoospermia is a highly effective contraceptive method provided that the partner is the sole sexual partner of the 
woman of childbearing potential and the absence of sperm has been confirmed. If not, an additional highly 
effective method of contraception should be used. Spermatogenesis cycle is approximately 90 days. 
Note: documentation of azoospermia for a male participant can come from the site personnel’s review of the 
participant’s medical records, medical examination, or medical history interview.) 
Highly Effective Methods That Are User Dependent Failure rate of <1% per year when used consistently and 
correctly. 
Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of 
ovulation 
− oral 
− intravaginal 
− transdermal 
− injectable 
Progestogen-only hormone contraception associated with inhibition of ovulation 
− oral 
− injectable 
Sexual abstinence 
Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual 
intercourse during the entire period of risk associated with the study intervention. The reliability of sexual 
abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the 
participant.) 
Effective Methodsd That Are Not Considered Highly Effective Failure rate of ≥1% per year when used 
consistently and correctly. 
• Progestogen-only oral hormonal contraception where inhibition of ovulation is not the primary mode of 
action 
• Male or female condom with or without spermicide 
• Cervical cap, diaphragm, or sponge with spermicide 
• A combination of male condom with either cervical cap, diaphragm, or sponge with spermicide (double- 
barrier methods)c 
a. 
Contraceptive use by men or women should be consistent with local regulations regarding the use of 
contraceptive methods for those participating in clinical studies. 
b. Failure rate of <1% per year when used consistently and correctly. Typical use failure rates differ 
from those when used consistently and correctly. 
c. 
Male condoms must be used in addition to hormonal contraception. If locally required, in 
accordance with Clinical Trial Facilitation Group (CTFG) guidelines, acceptable contraceptive 
methods are limited to those which inhibit ovulation as the primary mode of action. 
d. Considered effective, but not highly effective - failure rate of ≥1% per year. Periodic abstinence 
(calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides 
only, and lactational amenorrhea method (LAM) are not acceptable methods of contraception. 
e. 
Male condom and female condom should not be used together (due to risk of failure from friction). 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 92 of 106 
 
10.5. 
Appendix 5: Graft Versus Host Disease 
Table 6: 
MAGIC Criteria for Staging and Grading of Acute Graft Versus Host 
Disease 
Stage 
Skin 
(Active Erythema 
Only) 
Liver 
(Bilirubin) 
Upper GI 
Lower GI 
(Stool Output/Day) 
0 
No active 
(erythematous) 
GVHD rash 
<2 mg/dL 
No or intermittent 
nausea, vomiting, or 
anorexia 
Adult: <500 mL/day or <3 episodes/day. 
Child: <10 mL/kg per day or <4 
episodes/day. 
1 
Maculopapular rash 
<25% BSA 
2-3 mg/dL 
Persistent nausea, 
vomiting, or anorexia 
Adult: 500-999 mL/day or 
34 episodes/day. 
Child: 10-19.9 mL/kg per day or 4-6 
episodes/day. 
2 
Maculopapular rash 
25%50% BSA 
3.1-6 mg/dL 
- 
Adult: 1000-1500 mL/day or 57 
episodes/day. 
Child: 20-30 mL/kg per day or 7-10 
episodes/day. 
3 
Maculopapular rash 
>50% BSA 
6.1-15 mg/dL 
- 
Adult: >1500 mL/day or >7 episodes/day. 
Child: >30 mL/kg per day or >10 
episodes/day. 
4 
Generalized 
erythroderma 
(>50% BSA) plus 
bullous formation 
and desquamation 
>5% BSA 
>15 mg/dL 
- 
Severe abdominal pain with or without 
ileus or grossly bloody stool (regardless 
of stool volume). 
Overall clinical grade (based on most severe target organ involvement): 
Grade 0: No Stage 1 to 4 of any organ. 
Grade I: Stage 1 to 2 skin without liver, upper GI, or lower GI involvement. 
Grade II: Stage 3 rash and/or Stage 1 liver and/or Stage 1 upper GI and/or Stage 1 lower GI. 
Grade III: Stage 2 to 3 liver and/or Stage 2 to 3 lower GI, with Stage 0 to 3 skin and/or Stage 0 to 1 
upper GI. Grade IV: Stage 4 skin, liver, or lower GI involvement, with Stage 0 to 1 upper GI. 
BSA = body surface area; GI = gastrointestinal; GVHD = graft versus host disease; MAGIC = Mount Sinai Acute 
GVHD International Consortium. 
Source: Harris AC, Young R, Devine S, et al. International, multicenter standardization of acute graft-versus-host disease 
clinical data collection: a report from the Mount Sinai Acute GVHD International Consortium. Biol Blood Marrow 
Transplant. 
2016;22(1):4-10. 
 
Table 7: 
Response Definitions for Acute Graft Versus Host Disease 
Response Term 
Definition 
CR 
Complete resolution of all signs and symptoms of GVHD in all organs without intervening 
salvage therapies. 
PR 
Improvement of 1 stage in 1 or more organs involved by GVHD without progression in 
others. 
Mixed response 
Improvement in at least 1 involved organ with progression or newly developed GVHD in 1 or 
more organs. 
Progression 
Worsening in 1 or more organs by 1 or more stage without improvement in any involved 
organ. 
NR 
No improvement or deterioration in any organ within 14 days of therapy initiation. 
CR = complete response; GVHD = graft versus host disease; NR = no response; PR = partial response. 
Source: Center for International Blood & Marrow Transplant Research (CIBMTR). Clinical trial endpoints for patients with 
acute GVHD. 2009. https://www.cibmtr.org/Meetings/Materials/GVHDworkshop/pages/index.aspx. 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 93 of 106 
 
 
Table 8: 
National Institutes of Health Global Severity of Chronic Graft Versus Host 
Disease 
Mild Chronic GVHD 
Moderate Chronic GVHD 
Severe Chronic GVHD 
1 or 2 organs involved with no 
more than score 1 plus lung score 0 
3 or more organs involved with no 
more than score 1 or at least 
1 organ (not lung) with a score of 2 
or lung score 1 
At least 1 organ with a score of 3 or 
lung score of 2 or 3 
Key points: 
In skin: higher of the 2 scores to be used for calculating global severity. 
In lung: FEV1 is used instead of clinical score for calculating global severity. 
If the entire abnormality in an organ is noted to be unequivocally explained by a non-GVHD documented cause, that organ is 
not included for calculation of the global severity. 
If the abnormality in an organ is attributed to multifactorial causes (GVHD plus other causes), the scored organ will be used for 
calculation of the global severity regardless of the contributing causes (no downgrading of organ severity score). 
FEV1 = forced expiratory volume in the first second; GVHD = graft versus host disease. 
Source: Jagasia MH, Greinix HT, Arora M, et al. National Institutes of Health Consensus Development Project on Criteria 
for Clinical Trials in Chronic Graft-Versus-Host-Disease: I. The 2014 Diagnosis and Staging Working Group Report. Biol 
Blood Marrow Transplant. 2015;21:389-401.e1. 
 
Table 9: 
National Institutes of Health Response Determinations for Chronic Graft 
Versus Host Disease 
Organ 
Complete Response 
Partial Response 
Progression 
Skin 
NIH Skin Score 0 after 
previous involvement 
Decrease in NIH Skin Score 
by 1 or more points 
Increase in NIH Skin Score by 
1 or more points, except 0 to 1 
Eyes 
NIH Eye Score 0 after 
previous involvement 
Decrease in NIH Eye Score 
by 1 or more points 
Increase in NIH Eye Score by 
1 or more points, except 0 to 1 
Mouth 
NIH Modified Oral Mucosa 
Rating Score 0 after previous 
involvement 
Decrease in NIH Modified 
Oral Mucosa Rating Score of 
2 or more points 
Increase in NIH Modified 
Oral Mucosa Rating Score of 
2 or more points 
Esophagus 
NIH Esophagus Score 0 after 
previous involvement 
Decrease in NIH Esophagus 
Score by 1 or more points 
Increase in NIH Esophagus 
Score by 1 or more points, 
except 0 to 1 
Upper GI 
NIH Upper GI Score 0 after 
previous involvement 
Decrease in NIH Upper GI 
Score by 1 or more points 
Increase in NIH Upper GI 
Score by 1 or more points, 
except 0 to 1 
Lower GI 
NIH Lower GI Score 0 after 
previous involvement 
Decrease in NIH Lower GI 
Score by 1 or more points 
Increase in NIH Lower GI 
Score by 1 or more points, 
except from 0 to 1 
Liver 
Normal ALT, alkaline 
phosphatase, and total 
bilirubin after previous 
elevation of 1 or more 
Decrease by 50% 
Increase by 2×ULN 
Lungs 
Normal %FEV1 after 
previous involvement 
If PFTs not available, NIH 
Lung Symptom Score 0 after 
previous involvement 
Increase by 10% predicted 
absolute value of %FEV1 
If PFTs not available, 
decrease in NIH Lung 
Symptom Score by 1 or more 
points 
Decrease by 10% predicted 
absolute value of %FEV1 
If PFTs not available, increase 
in NIH Lung Symptom Score 
by 1 or more points, except 0 
to 1 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 94 of 106 
 
Organ 
Complete Response 
Partial Response 
Progression 
Joints and 
fascia 
Both NIH Joint and Fascia 
Score 0 and P-ROM score 25 
after previous involvement by 
at least 1 measure 
Decrease in NIH Joint and 
Fascia Score by 1 or more 
points or increase in P-ROM 
score by 1 point for any site 
Increase in NIH Joint and 
Fascia Score by 1 or more 
points or decrease in P-ROM 
score by 1 point for any site 
Global 
Clinician overall severity 
score 0 
Clinician overall severity 
score decreases by 2 or more 
points on a 0-10 scale 
Clinician overall severity 
score increases by 2 or more 
points on a 0-10 scale 
%FEV1 = percent predicted forced expiratory volume in the first second; ALT = alanine aminotransferase; GI = gastrointestinal; 
NIH = National Institutes of Health; PFT = pulmonary function test; P-ROM = photographic range of motion; ULN = upper 
limit of normal. 
Source: Lee ST, Wolff D, Kitko C, et al. Measuring therapeutic response in chronic graft-versus-host disease. Biol Blood 
Marrow Transplant. 2015;21(6):984-999. 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 95 of 106 
 
10.6. 
Appendix 6: Cytokine Release Syndrome Scale 
For patients who have a presumptive diagnosis of Cytokine Release Syndrome (CRS) based on the 
clinical judgement of the Investigator, CRS will be graded according to the ASTCT Consensus Grading 
for CRS (shown in Table 10) rather than by CTCAE. ASTCT characterizes CRS as: “A supraphysiologic 
response following any immune therapy that results in the activation or engagement of endogenous or 
infused T cells and/or other immune effector cells. Symptoms can be progressive, must include fever at 
the onset, and may include hypotension, capillary leak (hypoxia) and end organ dysfunction.” The 
ASTCT Consensus Grading was developed for chimeric antigen receptor (CAR)-T cell therapies in which 
sustained engagement between the CAR-T cells and targeted malignant cells is expected, leading to 
substantial rates of CRS. By contrast, CRS remains only a theoretical concern for virus-specific T cells. 
(For additional details, see Appendix 7, Section 10.7 below.) 
Table 10: 
ASTCT Consensus Cytokine Release Syndrome Grading Scale 
 
 
 
 
 
 
 
 
 
 
 
Note: Organ toxicities associated with CRS may be graded according to CTCAE v5.0 but they do not influence CRS 
grading.  
Note: Grade 5 CRS is defined as death due to CRS in which another cause is not the principle factor leading to the 
outcome. 
1. Fever is defined as temperature ≥38.0°C not attributable to any other cause. In patients who have CRS and then 
receive antipyretic or anticytokine therapy such as tocilizumab or steroids, fever is no longer required to grade 
subsequent CRS severity. In this case, CRS grading is driven by hypotension and/or hypoxia. 
2. CRS grade is determined by the more severe event: hypotension or hypoxia not attributable to any other cause. For 
example, a patient with temperature of 39.5°C, hypotension requiring 1 vasopressor, and hypoxia requiring low-flow 
nasal cannula is classified as grade 3 CRS. 
BiPAP = bilevel positive airway pressure; CPAP = continuous positive airway pressure; CRS = cytokine release 
syndrome; CTCAE = Common Terminology Criteria for Adverse Events. 
Source: Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and 
neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant. 2019;25(4):625-638. 
 
 
 
Grade 
CRS Parameter 
1 
2 
3 
4 
Fever [1] 
≥38.0°C 
≥38.0°C 
≥38.0°C 
≥38.0°C 
With 
Hypotension 
None 
Not requiring 
vasopressors 
Requiring 
vasopressors 
with or without 
vasopressin 
Requiring multiple 
vasopressors 
(excluding 
vasopressin) 
And/or [2] 
Hypoxia 
None 
Requiring lowflow 
nasal cannula 
(oxygen delivered 
at ≤6 L/minute) 
or blowby 
Requiring highflow 
nasal cannula 
(oxygen delivered 
at >6 L/minute), 
facemask, 
nonrebreather 
mask, or Venturi 
mask 
Requiring 
positive pressure 
(eg, CPAP, BiPAP, 
intubation, 
mechanical 
ventilation) 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 97 of 106 
 
References:  
1 KYMRIAH® (tisagenlecleucel) suspension for intravenous infusion, prescribing information. 
https://www.novartis.us/sites/www.novartis.us/files/kymriah.pdf. Accessed on 09 Nov 2020. 
 
2 Tzannou I, Papadopoulou A, Naik S, et al. Off-the-shelf virus-specific T cells to treat BK virus, human 
herpesvirus 6, cytomegalovirus, Epstein-Barr virus, and adenovirus infections after allogeneic hematopoietic 
stem-cell transplantation. J Clin Oncol. 2017;35(31):3547-3557.  
3 Porter DL and Maloney DG. Cytokine release syndrome (CRS). Post TW, ed. UpToDate. Waltham, MA. 
Updated 06 Apr 2020.  https://www.uptodate.com/contents/cytokine-release-syndrome-crs. Accessed on 09 Nov 
2020. 
4  Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release syndrome and 
neurologic toxicity associated with immune effector cells. Biol Blood Marrow Transplant. 2019;25(4):625-638. 
 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 100 of 106 
 
OR cytopathic adenoviral effect identified on biopsy 
 
OR 
 
• At least 2 suggestive signs or symptoms: diarrhea, abdominal pain, 
ileus, vomiting, GI hemorrhage AND 
• AdV isolated from the stool by culture or PCR AND 
• Other causative agents (e.g., bacterial, viral, amebic) ruled out AND 
endoscopic evidence of lesions (macroscopic or microscopic) not 
attributed to GVHD (i.e., biopsy-proven) 
 
Adenovirus 
pancreatitis6 
• Consistent clinical and imaging findings such as: 
o Suggestive signs or symptoms (abdominal pain, GI 
symptoms)  
o Amylase or lipase >5xULN 
o Imaging (eg, CT scan) findings suggesting pancreatitis 
 
AND 
 
• AdV identified by pancreatic biopsy or ERCP brushings/washings 
via antigen/IHC or culture OR 
• AdV detected by plasma PCR AND  
• Other causes (e.g., gallstones, hypertriglyceridemia, parasites, 
paramyxovirus, other viruses) ruled out 
 
Adenovirus 
hemorrhagic cystitis 
• Clinical signs and symptoms of cystitis, including dysuria, lower 
abdominal pain, and/or other bladder-associated pain or spasms 
AND 
• Grade ≥2 hematuria (per Bedi scale) AND 
• AdV viruria of >5 log10 copies/mL AND 
• 
No other cause for the HC is apparent 
Adenovirus 
nephritis 
• At least one of the following: 
o Suggestive signs or symptoms (impaired renal function, 
proteinuria, microscopic hematuria, hypertension, dysuria)  
o Enlarged kidney on imaging 
o Renal/bladder obstruction AND 
• AdV identified via renal biopsy via antigen/IHC or culture OR 
• AdV detected by urine PCR +/- plasma PCR and other causes (e.g., 
BK virus, JC virus, bacterial and drug-induced) ruled out 
Adenovirus 
encephalitis/myelitis6 
• At least one of the following signs/symptoms of encephalitis: 
o Abnormal CSF 
o Focal CNS deficit 
o Cognitive impairment 
o Visual symptoms 
o Seizure  
o Evidence of compatible lesions by CT scan or MRI  

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 104 of 106 
 
controlled phase II trial. Biol Blood Marrow Transplant. 2017;23(3):512‐521. 
doi:10.1016/j.bbmt.2016.12.621 
7. Ljungman P, Boeckh M, Hirsch HH, et al. Definitions of cytomegalovirus infection and disease 
in transplant patients for use in clinical trials. Clin Infect Dis. 2017;64(1):87‐91. 
doi:10.1093/cid/ciw668 
8. Ljungman P, Hakki M, Boeckh M. Cytomegalovirus in hematopoietic stem cell transplant 
recipients. Hematol Oncol Clin North Am. 2011;25(1):151-169. doi:10.1016/j.hoc.2010.11.011 
9. Ljungman P, de la Camara R, Robin C, et al. Guidelines for the management of cytomegalovirus 
infection in patients with haematological malignancies and after stem cell transplantation from 
the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis. 
2019;19(8):e260-e272. doi:10.1016/S1473-3099(19)30107-0 
10. Wingard JR. Prevention of viral infections in hematopoietic cell transplant recipients. Post TW, 
ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com (Accessed on June 15, 
2020.) 
11. US Food and Drug Administration. Cytomegalovirus in transplantation: Developing drugs to treat 
or prevent disease - Guidance for industry. https://www.fda.gov/media/112942/download 
(Accessed on June 15, 2020.) 
12. Razonable RR, Humar A. Cytomegalovirus in solid organ transplant recipients - Guidelines of the 
American Society of Transplantation Infectious Diseases Community of Practice. Clin 
Transplant. 2019;33(9):e13512. doi:10.1111/ctr.13512 
13. Azevedo LS, Pierrotti LC, Abdala E, et al. Cytomegalovirus infection in transplant 
recipients. Clinics (Sao Paulo). 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09 
14. Kotton CN, Kumar D, Caliendo AM, et al. The third international consensus guidelines on the 
management of cytomegalovirus in solid-organ transplantation. Transplantation. 
2018;102(6):900-931. doi:10.1097/TP.0000000000002191 
15. Mori T, Kato J. Cytomegalovirus infection/disease after hematopoietic stem cell 
transplantation. Int J Hematol. 2010;91(4):588-595. doi:10.1007/s12185-010-0569-x 
16. Boeckh M, Nichols WG, Papanicolaou G, Rubin R, Wingard JR, Zaia J. Cytomegalovirus in 
hematopoietic stem cell transplant recipients: Current status, known challenges, and future 
strategies. Biol Blood Marrow Transplant. 2003;9(9):543-558. doi:10.1016/s1083-
8791(03)00287-8 
17. Griffiths PD. Cytomegalovirus. In: Infections of the Central Nervous System, 4th Ed, Scheld WM, 
Whitley RJ, Marra CM (Eds), Wolters Kluwer Health, Philadelphia 2014. p. 168. 
18. Zöllner SK, Herbrüggen H, Kolve H, et al. Cytomegalovirus retinitis in children and adolescents 
with acute leukemia following allogeneic hematopoietic stem cell transplantation. Transpl Infect 
Dis. 2019;21(5):e13089.  
19. Gottschalk S, Rooney CM, Heslop HE. Post-transplant lymphoproliferative disorders. Annu Rev 
Med. 2005;56:29-44. doi:10.1146/annurev.med.56.082103.104727 
20. Rao N, Schepetiuk S, Choudhry M, et al. JC viraemia in kidney transplant recipients: to act or not 
to act? Clin Kidney J. 2012;5(5):471-473. doi:10.1093/ckj/sfs123 
21. Berger JR, Aksamit AJ, Clifford DB, et al. PML diagnostic criteria: consensus statement from the 
AAN Neuroinfectious Disease Section. Neurology. 2013;80(15):1430-1438. 
doi:10.1212/WNL.0b013e31828c2fa1 
22. Koralnik IJ. Progressive multifocal leukoencephalopathy (PML): Epidemiology, clinical 
manifestations, and diagnosis. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. 
https://www.uptodate.com (Accessed on June 15, 2020.) 
 
 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 105 of 106 
 
11. 
REFERENCES 
Ahmed IA, Farooqi MS, Vander L, et al. Outcomes of hematopoietic cell 
transplantation in patients with germline SAMD9/SAMD9L Mutations. Biol Blood 
Marrow Transplant. 
2019;25(11):2186–2196. doi:10.1016/j.bbmt.2019.07.007 
Braunlin E, Miettunen K, Lund T, et al. Hematopoietic cell transplantation for severe MPS 
I in the first six months of life: The heart of the matter. Mol Genet Metab. 
2019;126(2):117–120. doi:10.1016/j.ymgme.2018.11.007 
Crocchiolo R, Bramanti S, Vai A, et al. Infections after T-replete haploidentical 
transplantation and high-dose cyclophosphamide as graft-versus-host disease prophylaxis. 
Transpl Infect Dis. 2015;17(2):242-249. 
D'Souza A, Fretham C. Current uses and outcomes of hematopoietic cell transplantation 
(HCT): Center for International Blood & Marrow Transplant Research (CIBMTR) summary 
slides, 2019. Available at https://www.cibmtr.org (Accessed on April 29, 2020.) 
EuroQol Group (1990-12-01). "EuroQol--a new facility for the measurement of health-
related quality of life". Health Policy (Amsterdam, Netherlands). 16 (3): 199–208. 
doi:10.1016/0168- 8510(90)90421-9 
Green ML, Leisenring W, Xie H, et al. Cytomegalovirus viral load and mortality after 
haematopoietic stem cell transplantation in the era of pre-emptive therapy: a retrospective 
cohort study. Lancet Haematol. 2016;3(3):e119-e127. 
Hill JA, Mayer BT, Xie H, et al. The cumulative burden of double-stranded DNA virus 
detection after allogeneic HCT is associated with increased mortality. Blood. 
2017;129(16):2316-2325. doi:10.1182/blood-2016-10-748426. 
Lee DW, Santomasso BD, Locke FL, et al. ASTCT consensus grading for cytokine release 
syndrome and neurologic toxicity associated with immune effector cells. Biol Blood Marrow 
Transplant. 2019;25(4):625-638. 
Ljungman P, Boeckh M, Hirsch HH, et al. Definitions of cytomegalovirus infection and 
disease in transplant patients for use in clinical trials. Clin Infect Dis. 2017;64(1):87–91. 
doi:10.1093/cid/ciw668 
McQuellon, R., Russell, G., Cella, D. et al. Quality of life measurement in bone marrow 
transplantation: development of the Functional Assessment of Cancer Therapy-Bone 
Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant. 1997;19:357–368. 
https://doi.org/10.1038/sj.bmt.1700672 
Muftuoglu M, Olson A, Marin D, et al. Allogeneic BK virus-specific T cells for 
progressive multifocal leukoencephalopathy. N Engl J Med. 2018;379(15):1443–1451. 
doi:10.1056/NEJMoa1801540 
Mulanovich VE, Jiang Y, Lima M de, Shpall EJ, Champlin RE, Ciurea SO. Infectious 

AlloVir 
Clinical Study Protocol P-105-202 
Confidential & Proprietary Version 
3.0, 07 Apr 2021 
 
Page 106 of 106 
 
complications in cord blood and T-cell depleted haploidentical stem cell transplantation. 
Am J Blood Res. 2011;1(1):98-105. 
Papadopoulou A, Gerdemann U, Katari UL, et al. Activity of broad-spectrum T cells as 
treatment for AdV, EBV, CMV, BKV, and HHV6 infections after HSCT. Sci Transl Med. 
2014;6(242):242ra83. doi:10.1126/scitranslmed.300882. 
Sedláček, Petr, Petterson T, Robin M, Sivaprakasam P, Vainorius E, Brundage T, Chandak 
A, Mozaffari E, Nichols G, Voigt S. Incidence of Adenovirus Infection in Hematopoietic 
Stem Cell Transplantation Recipients: Findings from the AdVance Study. Biology of Blood 
and Marrow Transplantation, 2019 Apr; 25(4): 810-818. 
Shah NN, Ahn KW, Litovich C, et al. Outcomes of Medicare-age eligible NHL patients 
receiving RIC allogeneic transplantation: a CIBMTR analysis. Blood Adv. 2018;2(8):933–
940. doi:10.1182/bloodadvances.2018018531 
Slade M, Goldsmith S, Romee R, DiPersio JF, Dubberke ER, Westervelt P, Uy GL, 
Lawrence SJ. Epidemiology of infections following haploidentical peripheral blood 
hematopoietic cell transplantation. Transpl Infect Dis. 2017 Feb;19(1). 
Tzannou I, Papadopoulou A, Naik S, et al. Off-the-shelf virus-specific T cells to treat BK 
virus, human herpesvirus 6, cytomegalovirus, Epstein-Barr virus, and adenovirus infections 
after allogeneic hematopoietic stem-cell transplantation. J Clin Oncol. 2017;35(31):3547-
57. 
Tzannou I, Watanabe A, Naik S, et al. "Mini" bank of only 8 donors supplies CMV-
directed T cells to diverse recipients. Blood Adv. 2019;3(17):2571–2580. 
doi:10.1182/bloodadvances.2019000371 
Wais V, Bunjes D, Kuchenbauer F, Sorror ML. Comorbidities, age, and other patient-
related predictors of allogeneic hematopoietic cell transplantation outcomes. Expert Rev 
Hematol. 
2018;11(10):805–816. doi:10.1080/17474086.2018.1509703 
Wittes J, Wallenstein S. The power of the Mantel—Haenszel Test. J Am Stat 
Assoc. 1987;82:400, 1104-1109, DOI: 10.1080/01621459.1987.10478546 
Zecca M, Wynn R, Dalle JH, Feuchtinger T, Vainorius E, Brundage TM, et al. Association 
between adenovirus viral load and mortality in pediatric allo-HCT recipients: the 
multinational AdVance study. Bone Marrow Transpl. 2019 Feb 25. [Epub ahead of print]