Phase 2 Multicenter, Randomized, Double-blind, Placebo-controlled, Multiple Dosing Interval, 2-period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred Posoleuccel (ALVR105) Multivirus-specific T Cells in Kidney Transplant Recipients With Either High or Low Levels of BK Viremia
Phase: PHASE2
Conditions: BK Virus Nephropathy, BK Virus Infection
Sponsor: AlloVir

Protocol Number: P-105-201 
 
Official Title: Phase 2 Multicenter, Randomized, Double-blind, Placebo- Controlled, Multiple Dosing 
Interval, 2-Period Study of the Safety, Tolerability and Effectiveness of Adoptively Transferred 
Posoleucel (ALVR105) Multivirus-Specific T Cells in Kidney Transplant Recipients with either High or 
Low Levels of BK Viremia 
 
NCT Number: NCT04605484 
 
Document Date: 30-Sep-2021 

CLINICAL STUDY PROTOCOL 
 
Phase 2 multicenter, randomized, double-blind, placebo-controlled, multiple 
dosing interval, 2-period study of the safety, tolerability and effectiveness of 
adoptively transferred posoleucel (ALVR105) multivirus-specific T cells in 
kidney transplant recipients with either high or low levels of BK viremia 
Investigational Product: Posoleucel (ALVR105, formerly known as Viralym-M) 
Protocol Number: P-105-201 
 
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: 4.0 
Original Protocol: 06 Jul 2020 
Amendment 1: 24 May 2021 
Amendment 2: 14 June 2021 
Amendment 3: 30 September 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. 

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DOCUMENT HISTORY  
  
Document  
Date  
Original Protocol  
06-July-2020 
Amendment 1   
24-May-2021 
Amendment 2 
14-June-2021 
Amendment 3 
30-September-2021 
  
  
AMENDMENT 3: RATIONALE FOR CHANGES 
 
This amendment updates and supersedes Amendment 2 dated 14-June-2021. 
 
Modifications made to the protocol as a part of Amendment 3 and a brief rationale for the 
changes are summarized below.  
 
Major Revisions include:  
• Eliminated Cohorts A and B 
• Study now consists of a single cohort with 60 patients with screening (central 
laboratory) BK viral load between 350 and 10,000,000 copies/mL. Increasing from the 
previous maximum of 50,000 copies/mL to a maximum of 10,000,000 copies/mL allows 
for inclusion of a greater number of patients, including those with higher viral loads, in 
order to include patients with an even greater unmet medical need. 
• Added stratification based on screening BK viral load 
• Stratum 1 will consist of patients with a BK viral load 
 at 
screening 
• Stratum 2 will consist of patients with a BK viral load 
 
at screening 
• Stratification will allow for equal randomization among active and placebo arms for 
patient populations 
. 
• Changed local BK viral load (ie, pre-screening values) requirement from 1,000 to 
<10,000 copies/mL for Cohort A and 10,000 to 50,000 copies/mL for Cohort B to any 
positive local BK viral load, and clarified that whole blood or plasma results may be 
used for local BK viral load 
• Allowing results from local laboratories simplifies screening for sites, while making the 
final determination of eligibility reliant on the standardized VL testing at the central 
laboratory to ensure consistent screening data.  
• Allowed local BK viral load (ie, pre-screening values) to be within 90 days prior to 
screening (instead of 21 days) 
• Increasing the window for pre-screening simplifies screening for sites, while retaining the 
rigor and consistency of central laboratory testing for final determination of eligibility. 

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• For patients in Period 1 who have undetectable BK plasma viral loads at 2 or more 
consecutive assessments at least 2 weeks apart and who no longer require dosing visits, 
allowed subsequent study visits (excluding Weeks 8 and 12) to be conducted by a 
Sponsor-approved home health vendor in conjunction with a Sponsor-approved 
telehealth provider 
• Allowing more home-health visits reduces patient burden. 
• For all patients, allowed study visits after Week 12 to be conducted by a Sponsor-
approved home health vendor in conjunction with a Sponsor-approved telehealth 
provider 
• Allowing more home-health visits reduces patient burden. 
• Eliminated long-term follow-up period (ie, Weeks 48 to 96) 
• Study duration is now 26 weeks (2-week screening period, 12-week treatment period, 
12-week follow-up period). 
• Patients will be eligible for enrollment in a long-term observational study (ALVR105-
401) and will be encouraged to enroll in this study. 
• Eliminating the long-term follow-up reduces patient burden in this study, while allowing 
more flexible visit timing in the observational study. Also allows twice as much long-
term- follow up in the observational study (— up to 4 years— compared to the original 
protocol). 
• Eliminated sirolimus and everolimus as prohibited medications 
• Removed from prior/concomitant therapy in exclusion criterion #10 (Section 5.2). 
• Added as medications  that cannot be started during the first 12 weeks of the study to 
Excluded Medications and/or Procedures (Section 6.8.1). 
• Allowing patients with persistent BK viremia whose immunosuppression therapy prior to 
enrollment included these medications,  to allow them to participate in the study, while 
avoiding the confounding factor of initiating these medications during the treatment 
period.  
• Added interim administrative analyses and removed interim analyses 1 to 3 from the 
original protocol 
• The first administrative interim analysis will be performed by the Sponsor when 12 
patients in Stratum 1 
 have 
completed 8 weeks in the study 
• The second administrative interim analysis will be performed when 30 patients have 
completed 8 weeks in the study 
• Administrative interim analyses may be omitted or added at the discretion of the 
Sponsor to allow for long term planning, and to assess ending the study early. 
• Added United States Adopted Name and International Nonproprietary Name, 
posoleucel, in lieu of ALVR105 
 
AMENDMENT 2: RATIONALE FOR CHANGES 
 

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This amendment updates and supersedes Amendment 1 dated 24-May-2021. 
 
Modifications made to the protocol as a part of Amendment 2 and a brief rationale for the 
changes are summarized below.  
 
Major Revisions include:  
 
• Update to Data Safety and Monitoring Board (Section 10.1.5.1) 
• Removed requirement of pause to enrollment while the DSMB reviews safety data from 
the first 3 subjects enrolled in each respective cohort. The rationale for this change is that 
the recently published data demonstrates the well tolerated safety profile of virus-specific 
3rd party T cells (VSTs) when used to treat BK virus following kidney transplant. 
Moreover, the on-going ALVR105 studies of initial treated HCT patients show no 
reported cases of graft-versus-host disease (GVHD) and/or cytokine release syndrome 
(CRS), and the infusions were well tolerated. 
 
AMENDMENT 1: RATIONALE FOR CHANGES  
  
This amendment updates and supersedes P-105-201 Original Protocol, dated 06 July 2020, as 
follows:  
  
Modifications made to the protocol as a part of Amendment 1 and a brief rationale for the 
changes are summarized below.  
  
Major Revisions include:  
 
• Updates to Schedule of Activities (Section 1.3)  
• Shortened maximum screening period from 21 to 14 days. This was done given the 
change to allow a single viral load at the central lab to qualify a patient, assuming the 
patient’s viral load at the local lab (done as standard of care) is 
 
copies/mL for Cohort A. 
• Deleted CMV viral load from screening as the CMV-based exclusion criteria has been 
removed. 
• Amended language to allow for up to 3 home health visits for clinical and viral load 
assessments in the follow up period after the initial 12 week dosing period. This is done 
to minimize visits to hospitals and clinics during the COVID-19 pandemic, except when 
necessary for dosing in the initial 12 week period. 
• Deleted language around locally obtained donor specific antibodies as these are no 
longer required to qualify since they are obtained in the study. 
• Visit window days have been changed from 14 days to 7 days for weeks 14 to 24, as 
visits are every 2 weeks during this period of time. 
  
• 
Revisions to Inclusion and Exclusion criteria to broaden enrollment (section 5.1 and 5.2 
and in Synopsis) 

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• 
Updated the inclusion criteria to remove the 2-year eligibility window after kidney 
transplant to allow additional patients with BK viremia outside this 2-year post-
transplant window to also be eligible.  
• Updated the inclusion criteria to eliminate the exclusion for > 12 weeks of BK viremia 
to also allow participation of patients with stable persistent BK viremia of greater than 
12 weeks duration. 
• Eliminated the exclusion for > 12 weeks of BK viremia to allow participation of patients 
with stable persistent BK viremia of greater than 12 weeks duration. 
• Removed the 2-year eligibility window after transplant to allow additional patients with 
BK viremia outside this 2-year post-transplant window to be eligible. 
• Removed exclusion for patients with donor specific antibodies at transplant since the 
data on these antibodies can be accurately compared between central lab data obtained 
at randomization and subsequently. 
• Added belatacept to the list of prohibited medications. 
 
• Study treatment preparation (section 6.1.2) now refers to the Cell Therapy Manual 
• 
IP preparation and infusion procedure description has been removed from the protocol, 
and referral to the Cell Therapy Manual has been added, as the IP management is more 
extensively described in the Cell Therapy Manual.  
 
• Study treatment withdrawal (section 7.1) versus patient discontinuation (section 7.2) 
after receipt of a prohibited study treatment or after pregnancy. 
• 
Clarified by changes in sections 7.1 and 7.2 that patients who receive a prohibited 
medication or become pregnant may continue in the study for the purposes of observation 
but are ineligible to receive study treatment. 
 
• CHARMS study data in section 2.3.2.2 is now referenced to the IB. 
• 
As ALVR105 safety and efficacy data from the CHARMS study is more extensively 
described in the investigational brochure (IB), the specific data have been removed from 
section 2.3.2.3 and reference to the IB has been added. 
 
• 
Miscellaneous revisions to reflect administrative changes, correct typographical errors, 
or refer to current study documents such as the IB. 
• 
Changed references to the study treatment from Viralym-M to ALVR105 to conform to 
other Allovir protocols.  
• 
Removed transmission of infectious agent from the list of SAE examples to avoid 
confusion over whether such an event would always be an SAE. 
• 
Corrected typographical error that omitted a line in CTCAE grading to now include 
Grade 5 SAE. 
• 
Added names of certain the laboratory chemistry values obtained in the study to be 
consistent with the laboratory manual. 
 
 

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SIGNATURE PAGE 
STUDY TITLE:  
PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-
CONTROLLED, MULTIPLE DOSING INTERVAL, 2-PERIOD STUDY OF THE 
SAFETY, TOLERABILITY AND EFFECTIVENESS OF ADOPTIVELY 
TRANSFERRED POSOLEUCEL (ALVR105) MULTIVIRUS-SPECIFIC T CELLS IN 
KIDNEY TRANSPLANT RECIPIENTS WITH EITHER HIGH OR LOW LEVELS OF 
BK VIREMIA 
 
I, the undersigned, have read this protocol and agree that it contains all necessary information 
required to conduct the study. 
Signature 
 
 
 
 
 
 
 
Date 
 
 
 
AlloVir 
 
 
 
 
 
 
 

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INVESTIGATOR AGREEMENT 
By signing below, I agree that: 
I have read this protocol. 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. 
 
 
 
 
 
 
______________________________________________  
____________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
______________________________________________ 
Investigator’s Printed Name 

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TABLE OF CONTENTS 
Signature Page ................................................................................................................................ 6 
Investigator Agreement ................................................................................................................... 7 
Table of Contents ............................................................................................................................ 8 
List of Tables ................................................................................................................................ 13 
List of Figures ............................................................................................................................... 13 
List of Abbreviations .................................................................................................................... 14 
1 Protocol Summary .................................................................................................................. 17 
1.1 
Synopsis ........................................................................................................................ 17 
1.2 
Schema .......................................................................................................................... 19 
1.3 
Schedule of Activities ................................................................................................... 21 
2 Introduction ............................................................................................................................. 25 
2.1 
Study Rationale ............................................................................................................. 25 
2.2 
Background ................................................................................................................... 25 
2.3 
Posoleucel  ..................................................................................................................... 26 
2.3.1 
Overview of Nonclinical Studies with Posoleucel.......................................... 26 
2.3.2 
Overview of Clinical Studies with Virus-Specific T Cells ............................. 26 
2.3.2.1 
Results of an Initial Phase 1 Study with Viralym-C ......................... 26 
2.3.2.2 
Results of the ARMS Study with Donor-Derived Multivirus-
Specific T Cells (Administration Of Rapidly Generated Multivirus-
Specific Cytotoxic T-Lymphocytes For The Prophylaxis And 
Treatment Of EBV, CMV, Adenovirus, HHV6, And BK Virus 
Infections Post Allogeneic Stem Cell Transplant) ........................... 26 
2.3.2.3 
Results of the CHARMS Study with Third Party-Derived 
Multivirus-Specific T Cells, Posoleucel (Multivirus-specific T 
Cells for the Treatment of Virus Infections After Stem Cell 
Transplant) ....................................................................................... 27 
2.4 
Benefit/Risk Assessment ............................................................................................... 28 
2.4.1 
Potential Benefits ............................................................................................ 28 
2.4.2 
Potential Risks ................................................................................................ 28 
3 Objectives and Endpoints ....................................................................................................... 30 
4 Study Design ........................................................................................................................... 32 
4.1 
Overall Design ............................................................................................................... 32 

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4.2 
Scientific Rationale for Study Design ........................................................................... 33 
4.3 
Justification for Dose .................................................................................................... 34 
4.4 
End of Study Definition ................................................................................................ 34 
5 Study Population ..................................................................................................................... 35 
5.1 
Inclusion Criteria ........................................................................................................... 35 
5.2 
Exclusion Criteria .......................................................................................................... 36 
5.3 
Lifestyle Restrictions ..................................................................................................... 37 
5.3.1 
Meals and Dietary Restrictions ....................................................................... 37 
5.3.2 
Caffeine, Alcohol, and Tobacco ..................................................................... 37 
5.3.3 
Activity ........................................................................................................... 37 
5.4 
Screen Failures .............................................................................................................. 38 
6 Study Treatment(s) and Concomitant Therapy ....................................................................... 39 
6.1 
Study Treatment(s) Administered ................................................................................. 39 
6.1.1 
Cell Line Selection .......................................................................................... 41 
6.1.2 
Study Treatment Administration..................................................................... 41 
6.2 
Preparation/Handling/Storage/Accountability .............................................................. 42 
6.2.1 
Study Treatment Preparation and Dispensing................................................. 42 
6.2.2 
Storage and Accountability ............................................................................. 42 
6.3 
Measures to Minimize Bias: Randomization and Blinding........................................... 43 
6.4 
Study Treatment Compliance ........................................................................................ 44 
6.5 
Dose Modification ......................................................................................................... 44 
6.5.1 
Retreatment Criteria ........................................................................................ 44 
6.6 
Continued Access to Study Treatment after the End of the Study ................................ 44 
6.7 
Treatment of Overdose .................................................................................................. 44 
6.8 
Concomitant Therapy .................................................................................................... 44 
6.8.1 
Excluded Medications and/or Procedures ....................................................... 45 
6.8.2 
Supportive Care .............................................................................................. 45 
6.8.3 
Rescue Medication .......................................................................................... 46 
7 Discontinuation of Study Treatment and Patient Discontinuation/Withdrawal ..................... 47 
7.1 
Discontinuation of Study Treatment ............................................................................. 47 
7.1.1 
Rechallenge ..................................................................................................... 47 
7.2 
Patient Discontinuation/Withdrawal from the Study .................................................... 47 

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7.3 
Lost to Follow up .......................................................................................................... 48 
8 Study Assessments and Procedures ........................................................................................ 49 
8.1 
Efficacy Assessments .................................................................................................... 49 
8.1.1 
Viral Load ....................................................................................................... 49 
8.1.2 
Estimated Glomerular Filtration Rate ............................................................. 50 
8.1.3 
Human Leukocyte Antigen Antibodies .......................................................... 50 
8.2 
Safety Assessments ....................................................................................................... 50 
8.2.1 
Physical Examinations .................................................................................... 50 
8.2.2 
Vital Signs ....................................................................................................... 50 
8.2.3 
Electrocardiograms ......................................................................................... 50 
8.2.4 
Clinical Safety Laboratory Assessments ........................................................ 51 
8.2.5 
Pregnancy Testing ........................................................................................... 51 
8.2.6 
Suicidal Ideation and Behavior Risk Monitoring ........................................... 51 
8.3 
Adverse Events, Serious Adverse Events, and Other Safety Reporting ....................... 51 
8.3.1 
Time Period and Frequency for Collecting AE and SAE Information ........... 52 
8.3.2 
Method of Detecting AEs and SAEs .............................................................. 52 
8.3.3 
Follow-up of AEs and SAEs ........................................................................... 52 
8.3.4 
Regulatory Reporting Requirements for SAEs ............................................... 52 
8.3.4.1 
Expedited Reporting ......................................................................... 53 
8.3.5 
Pregnancy ........................................................................................................ 53 
8.3.6 
Cardiovascular and Death Events ................................................................... 54 
8.3.7 
Adverse Events of Special Interest ................................................................. 54 
8.3.7.1 
Special Situation Reports .................................................................. 54 
8.4 
Pharmacokinetics .......................................................................................................... 55 
8.5 
Genetics and/or Pharmacogenomics ............................................................................. 55 
8.6 
Biomarkers .................................................................................................................... 55 
8.7 
Immunogenicity Assessments ....................................................................................... 55 
8.8 
Medical Resource Utilization and Health Economics ................................................... 55 
9 Statistical Considerations ........................................................................................................ 56 
9.1 
Statistical Hypotheses ................................................................................................... 56 
9.2 
Sample Size Determination ........................................................................................... 56 
9.3 
Analysis Sets ................................................................................................................. 56 

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9.4 
Statistical Analyses ....................................................................................................... 56 
9.4.1 
General Considerations ................................................................................... 57 
9.4.2 
Primary Endpoint(s) ........................................................................................ 57 
9.4.3 
Secondary Endpoints ...................................................................................... 57 
9.4.4 
Tertiary/Exploratory Endpoint(s).................................................................... 57 
9.4.5 
Safety Analysis ............................................................................................... 57 
9.4.6 
Other Analyses ................................................................................................ 58 
9.5 
Interim Analyses ........................................................................................................... 58 
9.5.1 
Stopping Criteria ............................................................................................. 59 
9.5.1.1 
Stopping Criteria for Individual Patients .......................................... 59 
9.5.1.2 
Stopping Criteria for the Study ......................................................... 59 
10 Supporting Documentation and Operational Considerations ................................................. 60 
10.1 Appendix 1: Regulatory, Ethical, and Study Oversight Considerations ....................... 60 
10.1.1 
Regulatory and Ethical Considerations ........................................................... 60 
10.1.2 
Financial Disclosure........................................................................................ 60 
10.1.3 
Informed Consent Process .............................................................................. 61 
10.1.4 
Data Protection................................................................................................ 61 
10.1.5 
Committee Structure ....................................................................................... 61 
10.1.5.1 Data Safety and Monitoring Board ................................................... 61 
10.1.6 
Dissemination of Clinical Study Data............................................................. 61 
10.1.7 
Data Quality Assurance .................................................................................. 62 
10.1.8 
Source Documents .......................................................................................... 62 
10.1.9 
Study and Site Start and Closure .................................................................... 63 
10.1.10 Publication Policy ........................................................................................... 63 
10.2 Appendix 2: Clinical Laboratory Tests ......................................................................... 65 
10.3 Appendix 3: AEs and SAEs: Definitions and Procedures for Recording, Evaluating, 
Follow-up, and Reporting ............................................................................................. 67 
10.3.1 
Definition of AE ............................................................................................. 67 
10.3.2 
Definition of SAE ........................................................................................... 69 
10.3.3 
Recording and Follow-Up of AE and/or SAE ................................................ 70 
10.3.4 
Reporting of SAEs .......................................................................................... 71 
10.4 Appendix 4: Contraceptive and Barrier Guidance ........................................................ 74 
10.4.1 
Definitions....................................................................................................... 74 

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10.4.2 
Contraception Guidance.................................................................................. 76 
10.5 Appendix 5: Graft Versus Host Disease Scales ............................................................ 77 
10.6 Appendix 6: Cytokine Release Syndrome Scale ........................................................... 79 
10.7 Appendix 7: Modification of Immunosuppression ....................................................... 80 
11 References ............................................................................................................................... 81 

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LIST OF TABLES 
Table 1 
Period 1 (Weeks -2 to 12) ........................................................................................... 21 
Table 2 
Period 2 (Weeks 14 to 24; Follow-Up Period) ........................................................... 24 
Table 3 
Study Treatment Information ...................................................................................... 40 
Table 4 
Protocol-Required Safety Laboratory Tests .............................................................. 666 
Table 5 
MAGIC Criteria for Staging and Grading of Acute Graft Versus Host Disease ........ 77 
Table 6 
Response Definitions for Acute Graft Versus Host Disease ...................................... 78 
Table 7 
Cytokine Release Syndrome Scale ............................................................................. 79 
 
LIST OF FIGURES 
Figure 1 
Study Flow Chart ........................................................................................................ 20 
Figure 2 
Schema for Immunosuppression Modification ........................................................... 80 
 

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LIST OF ABBREVIATIONS 
Abbreviation 
Definition or Term 
AdV 
adenovirus 
AE 
adverse event 
AESI 
adverse event of special interest 
ALT 
alanine aminotransferase 
ALVR105 (posoleucel) Viralym-M  
AST 
aspartate aminotransferase 
ATG 
anti-thymocyte globulin 
BKV 
BK viremia 
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 and Safety Monitoring Board 
EBV 
Epstein-Barr virus 
ECG 
electrocardiogram 
eCRF 
electronic case report form 
EDC 
electronic data capture 
eGFR 
estimated glomerular filtration rate 
ET 
Early Termination visit 
FDA 
Food and Drug Administration 
FSH 
follicle-stimulating hormone 
GCP 
Good Clinical Practice 
GI 
gastrointestinal 
GVHD 
graft versus host disease 
HBV 
hepatitis B virus 

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Abbreviation 
Definition or Term 
HC 
hemorrhagic cystitis 
HCT 
hematopoietic cell transplant 
HCV 
hepatitis C virus 
HHV-6 
human herpesvirus 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 
IFN 
interferon 
IRB 
Institutional Review Board 
IRT 
interactive response technology 
ITT 
Intent-to-Treat 
IV 
Intravenous, -ly 
IVIG 
intravenous immunoglobulin 
JCV 
JC virus 
MAGIC 
Mount Sinai Acute GVHD International Consortium 
LLOQ 
lower limit of quantification 
MDRD 
Modified Dose in Renal Disease 
MTD 
maximum tolerated dose 
NCI 
National Cancer Institute 
PBMC 
peripheral blood mononuclear cell 
PBO 
placebo 
Posoleucel; PSL 
ALVR105 (Viralym M) 
PML 
progressive multifocal leukoencephalopathy 
PR 
partial response 
qPCR 
quantitative polymerase chain reaction 
RBC 
red blood cell 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SoA 
Schedule of Activities 

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Abbreviation 
Definition or Term 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
TEAE 
treatment-emergent adverse event 
ULN 
upper limit of normal 
VL 
Viral load 
Viralym-M 
ALVR105 (posoleucel) 
WOCBP 
woman of childbearing potential 
WONCBP 
woman of non-childbearing potential 
 

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1 
PROTOCOL SUMMARY 
1.1 
Synopsis 
Protocol Title:  Phase 2 multicenter, randomized, double-blind, placebo-controlled, multiple 
dosing interval, 2-period study of the safety, tolerability and effectiveness of adoptively 
transferred posoleucel (ALVR105) multivirus-specific T cells in kidney transplant recipients 
with either high or low levels of BK viremia 
Protocol Number: P-105-201 
Rationale:    
This is a proof-of-concept study of posoleucel (PSL, ALVR105, formerly Viralym-M), and the 
principal objective is to assess the safety and tolerability of PSL in kidney transplant recipients. 
The key secondary objective is to test the hypothesis that the administration of PSL to kidney 
transplant recipients with BK viremia will demonstrate superiority in suppressing BK viral load 
compared with placebo. 
Objectives and Endpoints:   
Objectives 
Endpoints 
Primary 
• To compare the safety and tolerability of 
PSL to placebo in kidney transplant 
recipients 
 
• Treatment-emergent adverse events 
(TEAEs) and changes in vital signs, 
physical exams, clinical laboratory 
assessments, and electrocardiograms 
(ECGs). 
Key Secondary  
• To assess the overall efficacy of PSL to 
suppress BK viral load compared with 
placebo 
 
• Change in BK viremia in patients 
receiving PSL compared to patients 
receiving placebo. 
Other Secondary 
• To compare the relative efficacy of different 
dosing regimens of PSL to placebo 
 
• Change in BK viremia in patients 
receiving different dosing regimens of 
PSL compared to patients receiving 
placebo 
 
Overall Design:    
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group 
multiple dosing interval, 2-period study of the safety, tolerability and efficacy of adoptively 
transferred PSL virus-specific T cells in kidney transplant recipients with BK viremia. 
An independent Data and Safety Monitoring Board (DSMB) will be convened for this study to 
routinely monitor patient safety; the DSMB will conduct the Interim Analyses according to the 
DSMB Charter. 

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This study is comprised of 2 periods. Period 1 includes a 2-week window for screening 
assessments followed by a 12-week treatment period for eligible patients. Period 2 consists of a 
12-week follow-up. Overall, the total duration of patient participation in the study is 
approximately 26 weeks (2 weeks for screening, 12 weeks of treatment, and 12 weeks of 
follow-up). The overall enrollment period is anticipated to be approximately 12 months. 
Patients will be stratified 
 
 
 
Brief Summary: 
The principal objective of this proof-of-concept study is to assess the safety and tolerability of 
PSL in kidney transplant recipients with BK viremia. The key secondary objective is to test the 
hypothesis that the administration of PSL to kidney transplant recipients will demonstrate 
superiority in suppressing BK viral load compared with placebo.  
Condition/Disease 
Male and female patients ≥18 years of age: 
• who had a kidney transplant performed ≥28 days prior to enrollment, and 
• who are diagnosed with BK viremia.  
Study Duration 
The total duration of patient participation is approximately 26 weeks, including 2 weeks for 
screening, a 12-week treatment period, and 12 weeks of follow-up. 
Treatment Duration 
Eligible patients will receive treatment with either PSL or placebo for 12 weeks.  
Health Measurement/Observation 
Patients will be monitored following randomization for safety, BK viral load, renal function, 
and immune function, including modification of immunosuppression reduction. 
Visit Frequency 
Study visits will occur weekly from Day 1 through Day 15, then every other week through 
Week 24. 
Expanded Access 
PSL is not available through an expanded access program for this study population. 
Intervention Groups and Duration: 
Patients will receive infusions of either PSL or placebo for 12 weeks. 
 
 
 
 Cryopreservation media (without cells) will serve as the 
placebo and will be identical in volume and appearance upon administration. All infusions will 
be administered intravenously (IV) (via peripheral or central line) over approximately 
 
as a slow push. Patients will receive the same dose for all infusions. 

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The study will consist of 3 treatment arms. To maintain the blind, all patients will receive an 
infusion (either PSL or placebo) 
 for the first 3 weeks of the dosing period, followed by 
) dosing for the remaining 9 weeks. The treatment arms and 
associated infusions are as follow: 
Administrative interim analyses are planned for the study. The Sponsor’s study team and 
Investigators will remain blinded to individual patient data during and after the administrative 
interim analyses. The first interim analysis will be performed by the Sponsor when 12 patients 
in Stratum 1 have completed 8 weeks in the study. The second interim analysis will be 
performed when 30 patients have completed 8 weeks in the study. Interim analyses may be 
omitted or added at the discretion of the Sponsor to allow for long term planning, and to assess 
ending the study or either arm early. Stopping rules for the study are detailed in Section 9.5.1. 
After the first 3 doses, patients who have undetectable BK plasma viral load at 2 or more 
consecutive assessments at least 2 weeks apart will discontinue PSL infusions. If a patient’s 
viral load becomes undetectable, the patient may be followed every 14 days for study 
evaluations as per the Schedule of Activities (SoA) (Section 1.3). No patients are permitted to 
receive a subsequent infusion of PSL/placebo if they develop new onset graft versus host 
disease (GVHD) (≥Stage 1; see Appendix 5, Section 10.5) or cytokine release syndrome (CRS 
>Grade 2; see Appendix 6, Section 10.6) at the proposed time for infusion of any subsequent 
dose. 
1.2 
Schema 
A summary of study design is shown in Figure 1. 
 
 

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1.3 
Schedule of Activities  
Table 1 
Period 1 (Weeks -2 to 12) 
At the discretion of the Investigator, and with the exception of Weeks 8 and 12 (which must be conducted at the site), study visits for patients who have 
undetectable BK plasma viral load at 2 or more consecutive assessments at least 2 weeks apart after 3 doses may be conducted by a Sponsor-approved 
home health vendor in conjunction with a Sponsor-approved telehealth provider. These visits may be conducted via video or telephone call. 
Study Week 
Weeks 
-2 to -1 
Day 1 
Week 1 
Week 2 
Week 4 
Week 6 
Week 8 
Week 10 
Week 12 
Study Day 
-14 to -1 
1[1] 
8 
15 
29 
43 
57 
71 
85 
Visit Window (Days) 
NA 
NA 
±2 
±3 
±3 
±3 
±3 
±3 
±3 
Study Procedures 
 
 
 
 
 
 
 
 
 
Informed consent[2] 
X 
 
 
 
 
 
 
 
 
I/E criteria 
X 
X 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
 
Prior & concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events[3] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Complete physical examination[4] 
X 
X 
 
 
 
 
 
 
X 
Targeted physical examination[4] 
 
 
X 
X 
X 
X 
X 
X 
 
Weight and height[5] 
X 
X 
 
 
X 
 
X 
 
X 
Vital signs[6] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG[7] 
X 
X[7] 
 
X[7] 
 
 
 
 
 
Documentation of HLA typing[8] 
X 
 
 
 
 
 
 
 
 
Clinical labs[9]  
X 
X 
 
X 
X 
X 
X 
X 
X 
Testing for HIV, HCV, and HBV[22] 
X 
 
 
 
 
 
 
 
 
BKV plasma viral load[10,11] 
X 
X 
 
X 
X 
X 
X 
X 
X 
Urine for biomarker[12] 
 
X 
 
 
X 
 
X 
 
X 
AdV, CMV, JCV, HHV-6 plasma, and EBV 
viral load[10] 
 
X 
 
 
X 
 
X 
 
X 
Pregnancy test 
X[13] 
X[14] 
 
 
X[14] 
 
X[14] 
 
X[14] 
FSH[15] 
X 
 
 
 
 
 
 
 
 
Randomization[16] 
 
X 
 
 
 
 
 
 
 
Provide patient cards 
 
X 
 
 
 
 
 
 
 

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Study Week 
Weeks 
-2 to -1 
Day 1 
Week 1 
Week 2 
Week 4 
Week 6 
Week 8 
Week 10 
Week 12 
Study Day 
-14 to -1 
1[1] 
8 
15 
29 
43 
57 
71 
85 
Visit Window (Days) 
NA 
NA 
±2 
±3 
±3 
±3 
±3 
±3 
±3 
Study treatment administration[17] 
 
X 
X 
X 
X 
X 
X 
X 
X 
Post infusion monitoring[18] 
 
X 
X 
X 
X 
X 
X 
X 
X 
Banked PBMCs for virus specific 
immunity[19] 
X 
 
 
X 
X 
X 
X 
 
X 
Blood for donor DNA[20] 
 
 
 
 
X 
 
 
 
X 
Kidney biopsy pathologic specimens for 
review (if clinically indicated)[23] 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Donor-specific antibodies [24] 
 
X 
 
 
 
 
 
 
X 
1. 
Unless noted otherwise, the Day 1 procedures must be performed within 96 hours of randomization and prior to study treatment administration. 
2. 
Prior to conducting any study-related activities, written informed consent to participate in the study must be provided by the patient. 
3. 
Adverse events will be monitored and documented from randomization through Week 24 in all patients.  
4. 
Complete physical examinations require the patient to be at the site, and will include, at a minimum, assessments of the Cardiovascular, Respiratory, Gastrointestinal and 
Neurological systems. Targeted physical examinations or assessments will include careful skin examination for GVHD, and other aspects as clinically indicated. 
5. 
Height and weight will be measured at screening; only weight will be measured at other specified later visits. For home visits, stated weight may be used. 
6. 
Includes body temperature, blood pressure, heart rate, and respiration rate and will be measured after resting for 5 minutes. For visits with infusions, vital signs will be 
measured within 30 minutes prior to infusion, at the end of the infusion, and at 15, 30, 45, and 60 minutes after the end of the infusion. A ±5 minute window will be permitted 
for all vital sign assessments. 
7. 
Performed within 1 hour after study treatment administration and at the end of study or early termination visit. ECGs will be obtained with the patient in a semi-supine 
position after a 5-minute rest. 
8. 
The HLA type of the patient and their donor kidney will be obtained from the medical record. 
9. 
CBC must include differential and LFTs must include alkaline phosphatase, bilirubin, AST, and ALT. Urinalysis must be performed. 
10. Viral loads of BKV in plasma will be measured. The results of analyses from screening must be available at the time of randomization. Results of central laboratory testing for 
viral load will be used for the purpose of determining eligibility/inclusion. Additional post-infusion samples may be collected, as clinically indicated. AdV, CMV, JCV, EBV, 
and HHV-6 viral loads will also be assessed. A whole blood or plasma BK viral load from the local laboratory may be used for the patient to qualify for screening if obtained 
≤90 days before the start of screening and with any positive BK viral load (may be reported as either copies/mL or IU/mL). 
11. Viral DNA isolated from blood samples will be stored for potential future sequencing/genotyping from the samples collected at baseline for viral load determination. Viral 
sequencing/genotyping will also potentially be performed in the event of viral recurrence and this sequencing result be compared with the baseline results.  
12. Urine samples will be obtained and will be stored for urinary polyomavirus haufen testing. 
13. A serum pregnancy test will be performed at screening for all patients of childbearing potential. 
14. A urine pregnancy test will be performed at the site prior to study therapy initiation for patients of childbearing potential.  If the result is negative, the patient will be eligible 
for study treatment administration and the remainder of the Day 1 testing/procedures will be performed. If the urine pregnancy result is positive, the patient must not receive 
study treatment. An on-site urine pregnancy test will also be performed at Weeks 4, 8, and 12 for patients of childbearing potential who are eligible for dosing. Dosing may 
only be completed following a negative test. 
15. FSH 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. 

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16. Randomization will occur after all screening procedures are complete, after all eligibility criteria are met, and prior to study treatment administration. Randomization will 
mark the end of the screening period. Patients who meet all of the inclusion criteria and none of the exclusion criteria will be randomized to receive sequential infusions of 
PSL cells or placebo. 
17. Patients will receive infusions of either PSL or placebo after all blood drawing procedures listed for their visit in the SoA. Patients in the active treatment arms will receive the 
same 
 cells dose for all infusions. Placebo infusions will be administered as appropriate to maintain the blind. As GVHD and CRS are a theoretical safety concern, the 
incidence and severity of GVHD and CRS will be monitored during the study. No patients are permitted to receive an infusion of PSL or placebo if they develop GVHD 
(≥Stage 1; see Appendix 5, Section 10.5) or CRS >Grade 2. If any patient develops GVHD or CRS >Grade 2, study treatment infusions should be stopped immediately, and 
the patient treated per standard of care. 
18. Patients will be monitored closely and must remain in the clinic for 1 hour after the end of each infusion. Vital signs, including body temperature, heart rate, respiration rate, 
and blood pressure, will be measured within 30 minutes prior to infusion, at the end of the infusion, and at 15, 30, 45, and 60 minutes after the end of the infusion. A ± 5 
minute window is permitted for all vital sign measurements. 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. 
19. Blood will be collected into a cell separation tube and processed to generate a PBMC fraction and a plasma fraction. These fractions will be cryopreserved for potential future 
evaluation of virus-specific T cell immune function/virus-specific T cell persistence and for potential future evaluation of cytokines and/or other humoral markers of 
inflammation and/or immune function. In addition, a tube of whole blood will be collected for exploratory determination of virus-specific- T cell immune function in whole 
blood. 
20. Blood will be obtained for (virus-specific T cell) donor DNA quantitation at Weeks 4, 12 and 24. Week 24 DNA may not be quantitated, depending on earlier results. 
21. Week 24 procedures should be performed on any patient who terminates the study early before Week 24. 
22. Serum will be screened for HIV, HBV and HCV antibodies with reflex nucleic acid testing of plasma. 
23. Severity of Biopsy (for clinical indication) Proven Acute Rejection will be adjudicated by a blinded review via expert pathologists. No biopsies are required per the protocol. 
24. Donor-specific antibody results should be derived from samples sent to the central laboratory. 
Abbreviations:  AdV = adenovirus; ALT = alanine aminotransferase; AST = aspartate aminotransferase; BKV = BK viremia; CBC = complete blood count; CMV = 
cytomegalovirus; CRS = cytokine release syndrome DNA = deoxyribonucleic acid; EBV = Epstein-Barr virus; ECG = electrocardiogram; ET = Early Termination Visit; FSH = 
follicle-stimulating hormone; GVHD = graft versus host disease; HBV = hepatitis B virus; HCV = hepatitis C virus; HIV = human immunodeficiency virus; HHV-
6 = human herpesvirus 6; HLA = human leucocyte antigen; I/E = inclusion and exclusion; JCV = JC virus; LFT = liver function test; NA = not applicable; PBMC = peripheral 
blood mononuclear cell; PSL=posoleucel; SoA = Schedule of Activities 
 

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Table 2 
Period 2 (Weeks 14 to 24; Follow-Up Period)  
At the discretion of the Investigator, all study visits during Period 2 may be conducted by a Sponsor-approved home health vendor in conjunction with 
a Sponsor-approved telehealth provider. These visits may be conducted via video or telephone call. 
Study Week 
Week 14 
Week 16 
Week 18 
Week 20 
Week 22 
Week 24/ET [1] 
Study Day 
99 
113 
127 
141 
155 
169 
Visit Window (Days) 
±7 Days 
±7 Days 
±7 Days 
±7 Days 
±7 Days 
±7 Days 
Study Procedures 
 
 
 
 
 
 
Prior & concomitant medications 
X 
X 
X 
X 
X 
X 
Adverse events[3] 
X 
X 
X 
X 
X 
X 
Targeted physical examination[4] 
X 
X 
X 
X 
X 
X 
Weight[5] 
 
X 
 
X 
 
X 
Vital signs[6] 
X 
X 
X 
X 
X 
X 
12-lead ECG[7] 
 
 
 
 
 
X 
Clinical labs[9]  
 
X 
 
X 
 
X 
BKV plasma viral load[10,11] 
X 
X 
X 
X 
X 
X 
AdV, CMV, JCV, EBV, and HHV-6 plasma viral 
load[10] 
 
X 
 
X 
 
X 
Banked PBMCs for virus-specific immunity[19] 
 
X 
 
X 
 
X 
Blood for donor DNA[20] 
 
 
 
 
 
X 
Obtain any clinically indicated kidney biopsy 
pathologic specimens for review[23] 
X 
X 
X 
X 
X 
X 
Donor-specific antibodies[24] 
 
 
 
 
 
X 
See footnotes and abbreviations following Table 1. 
 
 

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2 
INTRODUCTION 
AlloVir is developing  posoleucel (PSL, ALVR105, formerly Viralym-M), a novel multivirus-
specific cellular therapy, to treat a number of serious, virus-associated causes of morbidity and 
mortality after transplant, including those caused by infection or reactivation with BK viremia 
([BKV] and the related polyomavirus JC virus [JCV]), cytomegalovirus (CMV), human 
herpesvirus 6 (HHV-6), Epstein-Barr virus (EBV), and adenovirus (AdV). 
PSL (ALVR105) is a biological product consisting of PSL cells (third-party, multivirus-specific 
T cells with specificity for BKV, JCV, AdV, HHV-6, EBV, and CMV) in cryopreservation 
media.  
2.1 
Study Rationale 
This is a proof-of-concept study of PSL, and the principal objective is to assess the safety and 
tolerability of PSL in kidney transplant recipients with BK virus-associated nephropathy. The 
key secondary objective is to test the hypothesis that the administration of PSL to kidney 
transplant recipients will demonstrate superiority in suppressing BK viral load compared with 
placebo. 
2.2 
Background 
In healthy, immunocompetent individuals, T cell immunity defends against viral infections. In 
transplant recipients, the use of potent immunosuppressive regimens (and subsequent associated 
immune compromise) leaves patients susceptible to severe viral infections and diseases. Viral 
infections are major causes of mortality and morbidity, and they have become leading etiologies 
for -transplant-related mortality. 
BKV is a polyomavirus that causes disease primarily in immunocompromised individuals. After 
primary infection, the virus remains latent in genitourinary cells. In immunosuppressed kidney 
transplant recipients, the virus can reactivate and cause tubulointerstitial nephritis, and in some 
cases, ureteral stenosis (Goldberg 2016). Nephropathy secondary to BKV infection occurs in up 
to 10% of transplant recipients (Jawdeh 2017) and is usually seen within the first year following 
transplantation. There are no US Food and Drug Administration (FDA)-approved therapies for 
BKV infection in kidney transplant recipients. The current treatment consists of reduction in 
immunosuppression with close monitoring of allograft function; however, immunosuppression 
reduction may expose kidney transplant recipients to the risk of graft rejection.  
The cellular immune response to BKV plays a critical role in the control of BK virus replication. 
Several immune parameters predict an increased risk of high-level BK viremia; these include a 
low pre-transplant CD4+ T cell count (DeWolfe 2017), indicators of T cell exhaustion such as T 
cells with lower production of protective cytokines and interferon (IFN)-ɣ (Mueller 2011), and a 
lower number of BKV-specific polyfunctional CD8+ T cells (Schmidt 2014). 
Thus, development of an adoptively-transferred T cell treatment, such as PSL, may meet an 
unmet medical need for BKV infection in kidney transplant recipients. 

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2.3 
Posoleucel  
Posoleucel (PSL, ALVR105) is a biological product consisting of PSL cells 
 
 
.  
For additional information on PSL, refer to the current Investigator’s Brochure (IB). 
2.3.1 
Overview of Nonclinical Studies with Posoleucel  
Consistent with guidance from the FDA, AlloVir proceeded to clinical studies following 
completion of in vitro studies. No nonclinical animal pharmacology, pharmacokinetic, or 
toxicology studies of PSL have been conducted or are planned. For additional information 
related to nonclinical studies with PSL, see the Investigator’s Brochure. 
2.3.2 
Overview of Clinical Studies with Virus-Specific T Cells 
2.3.2.1 
Results of an Initial Phase 1 Study with Viralym-C 
Initially, AlloVir completed a Phase 1 study to assess the safety and efficacy of Viralym-C, a 
third-party, CMV-specific T cell product, in pediatric and adult allogeneic hematopoietic cell 
transplant (HCT) recipients with refractory CMV infections (Tzannou 2019). Similar to PSL, 
Viralym-C is generated from peripheral blood mononuclear cells (PBMCs) after expansion in the 
presence of overlapping viral peptides and cytokines. Unlike PSL, Viralym-C is only directed 
against a single virus, CMV. Although Viralym-C is a single virus-specific T cell product, the 
results of this study support the safety and efficacy of AlloVir’s allogeneic, virus-specific T cell 
products when used in a clinical setting. Briefly, a bank of 8 Viralym-C lines was generated from 
8 carefully selected, healthy, CMV-seropositive, transplant donor-eligible volunteers and was 
predicted to provide a suitably matched cell line for at least 95% of potential patients. Ten 
patients were treated with Viralym-C: each patient received a single intravenous (IV) infusion of 
2×107 partially human leukocyte antigen (HLA)-matched virus-specific T cells/m2 with the 
option to receive a second infusion after 4 weeks and additional infusions at biweekly intervals 
thereafter. Of the 10 treated patients, 8 patients received a single infusion and 2 patients required 
2 infusions for sustained benefit. There were no immediate infusion-related toxicities, and there 
were no cases of de novo or recurrent graft versus host disease (GVHD). Based on viral load 
(measured by quantitative polymerase chain reaction [qPCR]) and/or resolution of signs and/or 
symptoms, Viralym-C appeared to control CMV infections in all patients with 8 complete 
responses (CRs) and 2 partial responses (PRs) achieved within 4 weeks of infusion. One patient 
with CMV retinitis had complete resolution of disease following Viralym-C infusion. 
2.3.2.2 
Results of the ARMS Study with Donor-Derived Multivirus-Specific T Cells 
(Administration Of Rapidly Generated Multivirus-Specific Cytotoxic T-
Lymphocytes For The Prophylaxis And Treatment Of EBV, CMV, Adenovirus, 
HHV6, And BK Virus Infections Post Allogeneic Stem Cell Transplant) 
In order to broaden the range of viral infections targeted by virus-specific T cells, AlloVir 
developed donor-derived multivirus-specific T cells with specificity for BKV, AdV, HHV-6, 
EBV, and CMV. This initial open-label Phase 1/2 study was conducted to assess the safety and 
toxicity of the multivirus-specific T cells in patients at risk of developing AdV, BKV, CMV, 
EBV, and/or HHV-6 infections after allogeneic HCT. The first stage of the study was a Phase 1 

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dose-escalation study to evaluate the safety of 3 dose levels and to determine the maximum 
tolerated dose (MTD) level. Upon the completion of Phase 1, additional patients were accrued at 
the MTD level to evaluate a clinically relevant endpoint for antiviral activity in Phase 2. 
Patients received 
 
 donor-derived multivirus-specific cytotoxic T 
lymphocytes (CTLs)/m2 in a single infusion in the dose-escalation phase of the study, and 
 
multivirus-specific CTLs/m2 for the fixed-dose Phase 2 efficacy component (actual number of 
cells infused ranged between 
 
 
 cells per patient). Patients were followed for 
toxicity for 30 days, GVHD for 6 weeks, and antiviral responses for 3 months; long-term follow-
up continued for 12 months following the final CTL infusion. 
A total of 21 patients were enrolled, and all 21 patients completed the study. All doses were well 
tolerated. There were no adverse events (AEs) experienced by patients enrolled in the study that 
were considered treatment related. Three patients developed Stage 2 skin GVHD (Grade 1 
overall) and 1 patient developed Stage 3 skin GVHD (Grade 2 overall) in the 6-week initial 
follow-up period; all patients responded to topical steroids. 
2.3.2.3 
Results of the CHARMS Study with Third Party-Derived Multivirus-Specific 
T Cells, Posoleucel (Multivirus-specific T Cells for the Treatment of Virus 
Infections After Stem Cell Transplant) 
To investigate the safety and clinical efficacy of PSL, a multivirus-specific T cell product 
reactive for BKV, AdV, HHV-6, EBV, and CMV generated from third-party, healthy 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 PSL. In this study, patients received a single IV 
infusion of 2107 partially HLA-matched PSL 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.  
A total of 58 patients with drug-refractory infections following allogeneic HCT were infused 
with PSL 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 2017). For additional information on PSL, refer to the current Investigator’s 
Brochure (IB). 
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 homologous nature of BKV and JCV and on results of previous studies. 
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 JCV 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 natural history associated with JCV, activity of PSL in patients with JCV viremia 
will be monitored in this study. 

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2.4 
Benefit/Risk Assessment 
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of PSL may be found in the IB. 
2.4.1 
Potential Benefits 
A serious unmet medical need exists for patients experiencing viral infections and diseases such 
as BKV-associated nephropathy. Up to 10% of kidney transplant recipients will have BK plasma 
viral loads ≥10,000 copies/mL, a level that is predictive of an allograft biopsy indicating BK 
virus-associated nephropathy (Hirsch 2013; Bohl 2007; Schachtner 2015), which can progress to 
graft loss (Gardner 1984). Even with the best current treatments (principally immunosuppression 
reduction), many centers report allograft nephropathy, rejection, and graft failure more 
commonly than in non-BK viremic patients (Favi 2019; El-Husseini 2019; Sawinski 2015). 
There are no FDA- or European Medicines Agency-approved antiviral therapies for BK viremia 
or BK virus nephropathy in kidney transplant recipients. The CHARMS study and other related 
clinical studies strongly suggest that PSL is a safe and effective broad-spectrum therapy to treat 
commonly observed, severe virus-associated disease in immunocompromised patients. The 
results of these studies provide preliminary evidence of PSL’s efficacy in multiple opportunistic 
viral infections, including BKV, in immunocompromised patients. Since standard of care 
immunosuppression reduction in response to persistent high-level BK viremia has been 
associated with the development of donor-specific antibodies and graft rejection (Sawinski 
2015), a therapy such as PSL has the potential to be better than that of standard of care 
immunosuppression reduction. 
2.4.2 
Potential Risks 
PSL 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 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 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 PSL, 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 seen with administration of topical steroids. 
As with other biological therapies delivered by IV infusion, possible side effects of PSL infusion 
include allergic reaction (anaphylaxis), decreased oxygenation, nausea/vomiting, arrhythmia, and 
hypotension. 
A detailed breakdown of the time points for blood sample collection during the course of this 
study is provided in in Section 1.3.  
In order to minimize the volume of blood collected during the study, the blood volume of 
individual samples has been reduced to the maximum extent feasible. This has been done in a 
manner that is expected to maintain the scientific integrity of the study while minimizing the 
risks to patients.  

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No single blood draw will exceed approximately 72 mL, and the total blood volume collected 
during the first 8 weeks of the study will be approximately 280 mL (~4 mL/kg for a 70 kg 
patient). Over the entire 26-week course of the study, the total blood volume collected is outlined 
in the laboratory manual.  
For the collection of other study-related material from patients, there are no invasive procedures 
that are required for the study conduct beyond those procedures being used for the routine 
clinical care of these patients. 

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3 
OBJECTIVES AND ENDPOINTS 
 
Objectives 
Endpoints 
Primary 
• To compare the safety and tolerability of 
PSL to placebo in kidney transplant 
recipients 
 
• Treatment-emergent adverse events 
(TEAEs) and changes in vital signs, 
physical exams, clinical laboratory 
assessments, and electrocardiograms 
(ECGs) 
Key Secondary  
• To assess the overall efficacy of PSL to 
suppress plasma BK viral load compared 
with placebo 
 
• Change in BK viremia in patients 
receiving PSL compared to patients 
receiving placebo 
Other Secondary 
• To compare the relative efficacy of different 
dosing regimens of PSL to suppress BK 
viral load versus placebo 
 
• Change in BK viremia in patients 
receiving different dosing regimens of PSL 
compared to patients receiving placebo 
Exploratory 
• To assess change in estimated glomerular 
filtration rate (eGFR) over 24 weeks in 
recipients of PSL versus placebo 
 
• Change in eGFR by Modified Dose in 
Renal Disease (MDRD) formula in 
recipients of PSL versus placebo 
• To identify changes in donor-specific anti-
human leukocyte antigen (anti-HLA) 
antibodies in recipients of PSL versus 
placebo 
• Changes from baseline in levels of donor-
specific anti-HLA antibodies in recipients 
of PSL versus placebo 
• To determine the proportion of patients with 
resolution of BK viremia at 8 weeks post 
virus-specific T cell infusion 
• Proportion of patients with resolution of 
BK viremia at 8 weeks post - Virus-
Specific T cell infusion 
• To assess kidney allograft survival at 24 
weeks 
• Proportion of patients with eGFR 
>20 mL/min at 24 weeks 
• To assess the incidence of recrudescent or 
new infections with target viruses 
(including cytomegalovirus [CMV]), but 
principally BKV  
• Incidence of new target viral infections or 
recrudescent infections (ie, BKV, CMV, 
EBV, AdV, JCV, and/or HHV-6) as 
defined by onset of viremia and/or the 
presence of associated symptoms relative 
to baseline.  
• Length of BKV remission (ie, time from 
clearance of BK viremia to reappearance 
of BK viremia [plasma viral load 
>156 copies/mL × 2 measures that are at 
least 2 weeks apart] or end of study) 

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• To determine whether patients with 
initially low BK viral load (ie, <10,000 
copies/mL) can be prevented from 
developing viremia ≥10,000 copies/mL 
that leads to new or increased 
immunosuppression reduction 
• To determine whether patients with 
initially low BK viral load (ie, <10,000 
copies/mL) in the investigational arm(s) 
develop lower viral loads than the placebo 
arm 
• Number of patients with screening BK 
viremia <10,000 copies/mL who develop 
BK viremia ≥10,000 copies/mL 
(sustained or non-sustained) or who 
experience a medically significant event 
that leads to changes in 
immunosuppression reduction 
• The absolute viral load in patients in the 
investigational arms versus that in 
patients in the placebo arm with 
screening BK viremia <10,000 
copies/mL. 
 

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4 
STUDY DESIGN 
4.1 
Overall Design 
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, multiple dosing 
interval, 2-period study of the safety, tolerability and efficacy of adoptively transferred PSL 
virus-specific T cells in kidney transplant recipients with BK viremia. 
This study is comprised of 2 periods. Period 1 includes a 2-week window for screening 
assessments followed by a 12-week treatment period for eligible patients. Period 2 consists of a 
12-week follow-up. Overall, the total duration of patient participation in the study is 
approximately 26 weeks (2 weeks for screening, 12 weeks of treatment, and 12 weeks of follow-
up). The overall enrollment period is anticipated to be approximately 12 months. 
The protocol defines standardized consensus guidelines for the type of immunosuppression 
reduction in order to systematize the approach to immunosuppression reduction across sites 
(Appendix 7, Section 10.7). Administration of PSL in the active arms of the study may result in 
fewer patients meeting the criteria for initiation or intensification of immunosuppression 
reduction according to the protocol at their institution than in the placebo arm of the study, and 
changes to each patient’s immunosuppression will be monitored. 
Patients who meet all of the inclusion criteria and none of the exclusion criteria will be 
randomized to receive PSL or placebo infusions. Patients will be stratified 
 
 
 
 Patients will be monitored following randomization for safety, BK viral load, renal 
function, and immune function, including modification of immunosuppression reduction. 
Patients will receive infusions of either PSL or placebo for 12 weeks. The specific PSL cell line 
for infusion will be selected 
 
 
. Cryopreservation media (without cells) will serve as the placebo and will be 
identical in volume and appearance upon administration. All infusions will be administered 
intravenously (IV) (via peripheral or central line) over approximately 
 as a slow push. 
Patients will receive the same dose for all infusions. 
The study will consist of 3 treatment arms. To maintain the blind, all patients will receive an 
infusion (either PSL or placebo) 
 
 The treatment arms and associated infusions for 
Cohort A are as follow: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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• 
 
 
Administrative interim analyses are planned for the study. The Sponsor’s study team and 
Investigators will remain blinded to individual patient data during and after the administrative 
interim analyses. The first interim analysis will be performed by the Sponsor when 12 patients in 
Stratum 1 have completed 8 weeks in the study, and the second interim analysis will be 
performed when 30 patients have completed 8 weeks in the study. Interim analyses may be 
omitted or added at the discretion of the Sponsor to allow for long term planning, and to assess 
ending the study or either arm early, as described in the statistical analysis plan (SAP). See 
Figure 1 for a schematic representation of the study design. 
Stopping rules for each dosing interval arm and for the study are detailed in Section 9.5.1. 
After the fi
3 doses, patients who have undetectable BK plasma viral load at 2 or more 
consecutive assessments at least 2 weeks apart will discontinue PSL infusions. If a patient’s viral 
load becomes undetectable, such a patient may be followed every 14 days for study evaluations 
as per the Schedule of Activities (Section 1.3). No patients are permitted to receive a subsequent 
infusion of PSL if they develop new onset GVHD (≥Stage 1; see Appendix 5, Section 10.5) or 
cytokine release syndrome (CRS) (>Grade 2; see Appendix 6, Section 10.6) at the proposed time 
for infusion of any subsequent dose. 
An independent Data and Safety Monitoring Board (DSMB) will be convened for this study to 
routinely monitor patient safety and evaluate prespecified interim analyses to stop the study early 
(see Section 10.1.5). 
4.2 
Scientific Rationale for Study Design 
Even with the best current treatments (principally immunosuppression reduction), many centers 
report allograft nephropathy, rejection, and graft failure more commonly in patients with BK 
viremia than in those without (Favi 2019, El-Husseini 2019, Sawinski 2015). The unmet medical 
need in BK virus nephropathy is reflected in the continued use of (ineffective) antiviral 
treatments such as leflunomide, cidofovir, intravenous immunoglobulin G, and levofloxacin 
concurrently with immunosuppression reduction (Bruminhent 2019). 
PSL multivirus-specific T cells target BK virus infected cells, and thus offer a way to lower viral 
load in BK viremic kidney transplant recipients at risk for BK nephropathy. To date, 
immunosuppression reduction is the only therapy that has succeeded in lowering BK viral load, 
and even it has had limited success and can lead to increased risk of rejection and/or production 
of donor-specific antibodies. This proof-of-concept study will also identify the dosing interval 
for virus-specific T cell infusions needed to lower viral load in kidney transplant recipients on 
continued immunosuppression and potentially limit the damage caused by BK virus replication 
in the kidney allograft. 
The use of placebo in this clinical study is justified for the following reasons:  
1) A placebo control group is required to provide an objective, contemporaneous assessment 
of the therapeutic effects and AE profile of PSL. 
2) The use of an active control group in the study is not feasible since there are no approved, 
efficacious antiviral therapies for the treatment of BKV infections. 

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3) Investigators are permitted to administer standard of care immunosuppression reduction 
as per the algorithm included in Appendix 7 (Section 10.7). 
4.3 
Justification for Dose 
PSL is to be administered at a fixed cell dose. The fixed dose was selected based on data from 
previous clinical studies in which PSL cells were well tolerated, safe, and effective. 
 
 
 
 
 
 
 
 
 
 
The use of PSL in a solid organ transplant population that may be receiving several different 
chronic immunosuppressive agents justifies the need for dose interval ranging in this study. 
 
 
 
 
 
; to date, there are no data for the use 
of PSL in the setting of solid organ transplant. The use of other T cell regimens for the treatment 
of viral infections specific to the solid organ transplant setting has demonstrated preliminary 
efficacy and safety when cell are administered weekly for 3 weeks followed by a variable period 
of rest, depending on the presence or absence of disease progression (Prockop 2019). Two-
week -Virus-Specific T cell dosing intervals have been described in several studies in which 
suppression of BK viral load was observed; however, an incomplete and/or delayed virologic 
response was often observed (Flower 2020). 
 
 
 
 
 
 During this time, clinical safety and viral load will be monitored very 
closely by the DSMB. T cell persistence data will also be collected.  
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 patient is considered to have completed the study if he/she has completed all phases of the 
study including the Week 24 visit. 

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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 
Age 
1. Patients must be ≥18 years of age at the time of signing the informed consent. 
Type of Patient and Disease Characteristics 
2. Patients who had a kidney transplant performed ≥28 days prior to enrollment. 
3. BKV, based on the following criteria (both criteria a and b must be met): 
a. Any positive whole blood or plasma BK viral load at a local laboratory obtained 
≤90 days before the start of screening. 
b. Confirmation of BK viremia of 350 copies/mL – 10,000,000 copies/mL as 
determined by the central laboratory at screening.  
4. At least 1 identified, suitably matched PSL cell line for infusion is available.  
Sex 
5. Male and/or female 
Contraceptive use by men and women should be consistent with local regulations 
regarding the methods of contraception for those participating in clinical studies. 
a. 
Male patients: 
Male patients are eligible to participate if they agree to the following during the 
study treatment period and for at least 90 days after the last dose of study treatment: 
• 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 patients:  
• A female patient is eligible to participate if she is not pregnant or breastfeeding, 
and 1 of the following conditions applies: 

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• She is a woman of non-childbearing potential (WONCBP) as defined in 
Section 10.4.1 
OR 
• She is a WOCBP and using an acceptable contraceptive method as described 
in Section 10.4.2 during the study treatment period and for at least 90 days 
after the last dose of study treatment. The Investigator should evaluate the 
potential for contraceptive method failure (eg, noncompliance, recently 
initiated) in relationship to the first dose of study treatment. 
• A WOCBP must have a negative highly sensitive serum pregnancy test within 
21 days before the first dose of study treatment, see Section 8.2.5. 
• Additional requirements for pregnancy testing during and after study treatment 
are located in Section 8.2.5. 
• 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 
6. Capable of giving signed informed consent as described in Section 10.1.3 which includes 
compliance with the requirements and restrictions listed in the informed consent form 
(ICF) and in this protocol.  
5.2 
Exclusion Criteria 
Medical Conditions 
1. Undergone allogeneic hematopoietic cell transplantation. 
2. Evidence or history of GVHD or CRS (Appendix 5 [Section 10.5] and Appendix 6 
[Section 10.6], respectively).  
3. Uncontrolled or progressive bacterial or fungal infections (ie, evidence of bacteremia, 
fungemia, dissemination, and/or organ-specific infection not well controlled by present 
therapies). 
4. Uncontrolled or progressive viral infections (ie, evidence of viremia, dissemination, 
and/or organ-specific infection not well controlled by present therapies) not targeted by 
PSL. 
5. Uncontrolled or progressive EBV-associated post-transplant lymphoproliferative 
disorder. 
6. Known or presumed pneumonia. 
7. Hemodynamic or respiratory instability defined as either of the following: 
a. Requirement for continuous infusions of inotropes or vasopressors for blood pressure 
support. 
b. Requirement for endotracheal intubation or mechanical ventilation. 

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8. Evidence of any medical condition that in the opinion of the Investigator might interfere 
with the patient’s ability to participate in the trial. 
Prior/Concomitant Therapy 
9. Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone dose 
>0.5 mg/kg/day or equivalent). 
10. Patients who received, or are planned to receive, abatacept or belatacept, within 3 months 
of screening, or who received equine anti-thymocyte globulin ([ATG] Atgam®) or rabbit 
ATG (Thymoglobulin ®) in doses of >4.5 mg/kg or alemtuzumab (Campath-1H) or other 
immunosuppressive T cell-targeted monoclonal antibodies <28 days prior to 
randomization. 
Prior/Concurrent Clinical Study Experience 
11. Receipt of other investigational antiviral treatments (eg, anti-BK monoclonal antibodies) 
within 28 days or 5 half-lives (whichever is longer) prior to randomization. 
Diagnostic assessments 
12. Liver dysfunction, defined as liver transaminases (ie, aspartate aminotransferase or 
alanine aminotransferase) >5 times the upper limit of normal (ULN) or direct bilirubin 
>2 times the ULN reference per local laboratory. 
13. Renal dysfunction, defined as estimated glomerular filtration rate (eGFR) (estimated by 
Modified Dose in Renal Disease [MDRD] formula) <20 mL/min/1.73 m2. 
Other Exclusions 
14. Pregnant or nursing or planning to become pregnant. 
15. ABO incompatible or complement-dependent lymphocytotoxic crossmatch positive 
transplant (isolated positive B cell crossmatches are not an exclusion criterion). 
16. Weight <40 kg. 
17. History of hypersensitivity to any of the components of the Investigational Product. 
5.3 
Lifestyle Restrictions 
This section is not applicable. 
5.3.1 
Meals and Dietary Restrictions 
This section is not applicable. 
5.3.2 
Caffeine, Alcohol, and Tobacco 
This section is not applicable. 
5.3.3 
Activity 
This section is not applicable. 

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5.4 
Screen Failures 
Screen failures are defined as patients 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 patients 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). If a matching PSL line is not available, resulting in the patient 
being a screen failure, the HLA type data will be collected in addition to the minimal information 
required to meet the Consolidate Standards of Reporting Trials.  
Individuals who do not meet the criteria for participation in this study (screen failure) may be 
rescreened following discussion with, and approval of, the Sponsor. 

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6 
STUDY TREATMENT(S) AND CONCOMITANT THERAPY 
Study treatment is defined as any investigational intervention(s), marketed product(s), placebo, 
or medical device(s) intended to be administered to a study patient according to the study 
protocol. 
6.1 
Study Treatment(s) Administered 
PSL is a third-party, donor-derived, “off-the-shelf,” Virus-specific T cell product with specificity 
for BKV, AdV, CMV, EBV, and HHV-6 (with additional cross-reactive specificity for JCV) that 
is cryopreserved and ready for immediate use. The placebo arm will receive separate IV 
infusions of cryopreservation media (without cells) as placebo. 
For more information, see the Investigator’s Brochure.  
PSL cell lines will be checked for cell concentration, viability, identity, phenotype, potency, 
endotoxin, mycoplasma, and sterility.  
 

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Table 3 
Study Treatment Information 
Arm Name 
 
 
 
 
Placebo 
Intervention Name 
PSL 
PSL 
Placebo 
Type 
Drug 
Drug 
Drug 
Dosage formulation 
Ampule (Cryovial) 
Ampule (Cryovial) 
Ampule (Cryovial) 
Unit dose strength(s) 
 
 
 
 
Dosage Level(s) 
 PSL cells 
 
 
 PSL cells 
 
 
 
 
  
Placebo 
 
 
Route of 
Administration  
IV slow push 
 
IV slow push 
 
IV slow push 
 
Use 
Experimental 
Experimental 
Placebo control 
IMP and NIMP 
IMP  
IMP  
IMP 
Sourcing 
Provided centrally by the Sponsor  
Provided centrally by the Sponsor  
Provided centrally by the Sponsor  
Packaging and 
Labeling 
Study treatment will be provided in 
cryovials. Each cryovial will be labeled 
as required per country requirement 
Study treatment will be provided in 
cryovials. Each cryovial will be labeled 
as required per country requirement 
Study treatment will be provided in 
cryovials. Each cryovial will be labeled 
as required per country requirement 
Current/ Former 
Name(s) or Alias(es) 
Posoleucel/ALVR105, Viralym M 
Posoleucel/ALVR105, Viralym M 
Not applicable 
Abbreviations: IMP = investigative medicinal product; IV = intravenous; Q = every. 
 

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6.1.1 
Cell Line Selection 
PSL cell lines will be selected for each patient based on an overall HLA match 
 
as outlined below. The HLA alleles used for evaluation of matching are 
HLA-A, HLA-B, HLA-DR, and HLA-DQ. 
The appropriate study treatment (ie, the cell lines for infusion) for patient administration will be 
selected 
 
. 
 
 
 
 
 
 
 
 
 
6.1.2 
Study Treatment Administration 
Randomization of patients to PSL versus placebo will occur only after cell line matching and 
selection has been confirmed (to satisfy inclusion criteria).  
Premedication is not required, except for patients with a prior history of reaction to blood 
products. These patients may receive premedication with 0.25 to 0.5 mg/kg (maximum dose of 
25 mg) diphenhydramine (IV or oral) and/or 5 to 10 mg/kg (maximum dose of 1000 mg) 
acetaminophen (IV or oral) prior to study treatment administration. Premedication with 
corticosteroids is prohibited. 
At or close to the time of administration, the product will be thawed. For further details on 
product preparation prior to infusion, please see the Cell Therapy Manual. 
Patients will be monitored according to institutional standards for the administration of blood 
products and, at a minimum, according to the following requirements: 
• Patients in an outpatient setting must remain in the clinic for 1 hour after the end of the 
infusion. 
• Patients must remain on continuous pulse oximetry for 30 minutes after the end of the 
infusion. 
• Vital signs will be monitored within 30 minutes prior to the infusion, at the end of infusion, 
and at 15, 30, 45, and 60 (±5) minutes after the end of the infusion. 
All findings must be recorded in the electronic case report form (eCRF). 
Patients will receive supportive care for acute or chronic toxicity, including blood components, 
antibiotics, or other interventions as appropriate per local treatment guidelines. See Section 6.8.2 
for additional information. 
If a patient experiences an infusion reaction, 0.25 to 0.5 mg/kg (maximum dose of 25 mg) 
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(IV or oral) may be administered as treatment. The maximum recommended single and daily 
doses of diphenhydramine and acetaminophen should not be exceeded. In the case of suboptimal 
control of an infusion reaction or the need to use corticosteroids for treatment of an infusion 
reaction, doses of 0.5mg/kg/day of prednisone or equivalent should be considered first. 
6.2 
Preparation/Handling/Storage/Accountability 
1. The Investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study treatment received and any discrepancies are 
reported and resolved before use of the study treatment. 
2. Only patients enrolled in the study may receive study treatment and only authorized site 
staff may supply or administer study treatment. All study treatments must be stored in a 
secure, environmentally controlled, and monitored (manual or automated) area in 
accordance with the labeled storage conditions with access limited to the Investigator and 
authorized site staff. 
3. The Investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study treatment accountability, reconciliation, and record maintenance (ie, 
receipt, reconciliation, and final disposition records). 
4. Further guidance and information for the final disposition of unused study treatment are 
provided in the Cell Therapy Manual.  
6.2.1 
Study Treatment Preparation and Dispensing 
PSL and placebo will be supplied in cryovials, which are to be transported from vapor phase 
liquid nitrogen storage at the clinical site to the cell-thawing and preparation location in a liquid 
nitrogen dewar or other suitable container. Details of the cell thawing, preparation for dosing, 
and administration to the patient will be provided to clinical sites in a separate Cell Therapy 
Manual. 
6.2.2 
Storage and Accountability 
PSL or placebo is stored in the vapor phase of liquid nitrogen in a continuously monitored 
storage freezer. 
All material containing PSL or placebo will be treated and disposed of as hazardous waste in 
accordance with governing regulations and clinical site procedures. 
PSL and placebo accountability are the responsibility of the Principal Investigator and Sponsor. 
However, this responsibility may be delegated to a suitably qualified Investigator or designee 
who has had appropriate study-specific training that has been documented. The Sponsor will 
maintain records that will allow anonymous traceability of each PSL cell line to the third-party 
PBMC donor from whom it originated. These records will be maintained for 30 years after 
expiry for each cell line. 
Detailed records will be maintained to allow for accurate accountability of PSL and placebo as 
per applicable Sponsor and clinical site procedures. For further details and specifications, see the 
Cell Therapy Manual. 

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6.3 
Measures to Minimize Bias: Randomization and Blinding 
This study is blinded to safeguard the integrity of the AE determination process, and to ensure 
that decisions regarding discontinuation of infusions for apparent efficacy are made in an 
unbiased fashion. 
Study using 
IVRS/IWRS 
All patients will be centrally assigned to randomized study treatment 
using an Interactive Voice/Web Response System (IVRS/IWRS). Before 
the study is initiated, the telephone number and call-in directions for the 
IVRS and/or the log in information and directions for the IWRS will be 
provided to each site. 
Study treatment will be dispensed at the study visits summarized in the 
Schedule of Activities (SOA, Section 1.3). 
The Sponsor designee (eg, interactive response technology [IRT] vendor) will have a designated 
randomization administrator who will maintain the randomization codes in accordance with 
standard operating procedures to ensure the blind integrity is properly maintained. Care should 
be exercised to ensure that only Sponsor personnel who require knowledge of treatment 
assignments will be unblinded (eg, staff involved in Suspected Unexpected Serious Adverse 
Reaction [SUSAR] reporting). 
Blind Break 
(IVRS/IWRS) 
The IVRS/IWRS will be programmed with blind-breaking instructions. 
In case of an emergency, the Investigator has the sole responsibility for 
determining if unblinding of a patients’ intervention assignment is 
warranted. Patient safety must always be the first consideration in 
making such a determination. If the Investigator decides that 
unblinding is warranted, the Investigator should make every effort to 
contact the Sponsor prior to unblinding a patient’s intervention 
assignment unless this could delay emergency treatment of the patient. 
If a patient’s intervention assignment is unblinded, the Sponsor must 
be notified within 24 hours after breaking the blind. The date and 
reason that the blind was broken must be recorded in the source 
documentation and case report form, as applicable. 
Unblinding should only occur in the event of an emergency or AE for which it is necessary to 
know the study treatment to determine an appropriate course of therapy. If the patient’s study 
treatment must be unblinded, the Investigator or qualified designee should contact IRT for the 
study treatment information. The IRT documentation indicating the blind break at the site must 
be retained with the patient’s source documentation in such a way as to avoid unblinding the 
treatment assignment to other site or Sponsor blinded personnel. 
If possible, the Investigator should attempt to contact the Medical Monitor prior to unblinding. If 
not possible, the Investigator should notify the Medical Monitor as soon as possible of the 
unblinding without disclosing the treatment assignment of the unblinded patient. The 
Investigator must document the patient’s identification, the reason for breaking the blind, and the 
date and time for breaking the blind. Following unblinding, the Investigator must withdraw the 
patient from the study. 

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6.4 
Study Treatment Compliance 
When patients are dosed at the site, they will receive study treatment directly from the 
Investigator or designee, under medical supervision. The date and time of each dose 
administered in the clinic will be recorded in the source documents and on the appropriate eCRF. 
The dose of study treatment and study patient identification will be confirmed at the time of 
dosing by a member of the study site staff other than the person administering the study 
treatment. 
6.5 
Dose Modification 
This section is not applicable. 
6.5.1 
Retreatment Criteria 
As GVHD is a theoretical safety concern, the incidence and severity of GVHD will be monitored 
during the study. No patients will be permitted to receive a subsequent infusion of PSL if they 
develop new onset GVHD (≥Stage 1; see Appendix 5, Section 10.5) or CRS (>Grade 2; see 
Appendix 6, Section 10.6). 
After the first 3 doses, patients who have undetectable BK plasma viral load at 2 or more 
consecutive assessments at least 2 weeks apart will discontinue PSL infusions. If a patient’s viral 
load becomes undetectable in this way such patients may be followed every 14 days for study 
evaluations as per the SoA (Section 1.3). 
6.6 
Continued Access to Study Treatment after the End of the Study 
No further treatment will be provided after the last dose of PSL (or placebo) after Week 12. 
However, patients will continue in the study for evaluation of safety, efficacy, and other 
endpoints for an additional 12 weeks. 
6.7 
Treatment of Overdose 
For this study, any dose of PSL greater than 
cells 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 interval should be extended. 
• 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 
All medications, including transplant immunosuppression, used within 30 days before screening 
will be recorded. All concomitant medications and concurrent therapies will be documented as 

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indicated in 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. 
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. 
Standard of care immunosuppression reduction is permitted as per the guidelines for the type of 
immunosuppression reduction that are provided in Appendix 7 (Section 10.7). The typical 
immunosuppression regimen for kidney transplant patients, which includes a calcineurin 
inhibitor, an anti-metabolite, commonly mycophenolate mofetil or mycophenolic acid, with or 
without low dose prednisone, is included in Section 10.7, Figure 2. If a patient’s 
immunosuppression regimen includes sirolimus or everolimus, a change in these agents based on 
BK viral load is not usually made; for this reason they are not included in Figure 2, and patients 
taking these medications who require changes in dose of their sirolimus or everolimus will 
require discussion with the Medical Monitor. These guidelines should be followed in order to 
standardize the approach to immunosuppression across sites. Administration of PSL in the active 
arms of the study may result in fewer patients meeting the criteria for modification of 
immunosuppression reduction according to the protocol at their institution than in the placebo 
arm of the study, and changes to each patient’s immunosuppression will be monitored and may 
be summarized as an exploratory endpoint. 
6.8.1 
Excluded Medications and/or Procedures 
All patients may receive available supportive therapy with approved treatments, but initiation of 
therapy for the attempted treatment of BK virus infection with sirolimus, everolimus, cidofovir, 
brincidofovir, fluoroquinolones (eg, ciprofloxacin), intravenous immunoglobulin (IVIG) or 
leflunomide during the first 12 weeks after randomization is prohibited.  
Receipt of other investigational antiviral treatments (eg, anti-BK virus monoclonal antibodies) 
within 28 days or 5 half-lives (whichever is longer) prior to randomization and throughout the 
duration of the study is prohibited.  
T cell ablative therapies such as antithymocyte globulin, alemtuzumab (Campath-1H), or other 
immunosuppressive T cell-targeted monoclonal antibodies are prohibited during the study. Daily 
doses of corticosteroids exceeding 0.5 mg/kg prednisone (or equivalent) are also prohibited 
during the study. 
6.8.2 
Supportive Care 
The following supportive care measures are permitted: 
• Analgesics 
• Narcotics 
• IV hydration 
• Bladder irrigation 
• Antispasmodics 

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• Transfusion of red blood cells (RBCs) 
• Transfusion of platelets 
• Transfusion of fresh frozen plasma 
• Nephrostomy tube placement 
All supportive care measures must be documented in the patient study records and the eCRF. 
6.8.3 
Rescue Medication 
This section is not applicable. 

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7 
DISCONTINUATION OF STUDY TREATMENT AND PATIENT 
DISCONTINUATION/WITHDRAWAL 
7.1 
Discontinuation of Study Treatment 
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 ≥ Grade 1 acute GVHD within 6 weeks, or a Grade 3 to 4 non-hematologic 
AE within 4 weeks from last PSL 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 new malignancy.  
4. Occurrence of Grade 3 or 4 CRS. If this occurs, the patient’s toxicities will be followed 
until resolution or until the patient’s participation in the study ends. 
5. Requirement for prohibited concomitant medication 
6. Pregnancy 
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 
Rechallenge 
This section is not applicable. 
7.2 
Patient 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 
• Patient failure to comply with protocol requirements or study-related procedures 
• Termination of the study by the Sponsor or the regulatory authority 
If a patient withdraws prematurely from the study due to the above criteria or for any other 
reason, study staff should make every effort to complete the full panel of assessments scheduled 
for the Week 24 (Day 169) Visit. The reason for patient withdrawal must be documented in the 
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If the patient 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 patient 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. 
Withdrawn patients will not be replaced. 
7.3 
Lost to Follow up 
A patient 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 patient fails to return to the clinic for a required study 
visit: 
• The site must attempt to contact the patient and reschedule the missed visit as soon as 
possible and counsel the patient on the importance of maintaining the assigned visit 
schedule and ascertain whether or not the patient wishes to and/or should continue in the 
study. 
• Before a patient is deemed lost to follow up, the Investigator or designee must make 
every effort to regain contact with the patient (where possible, 3 telephone calls and, if 
necessary, a certified letter to the patient’s last known mailing address or local equivalent 
methods). These contact attempts should be documented in the patient’s medical record. 
• Should the patient 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. 
 

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8 
STUDY ASSESSMENTS AND PROCEDURES 
• Study procedures and their timing are summarized in the SoA (Section 1.3). 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 patient should continue or discontinue study 
treatment. 
• 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 
patients meet all eligibility criteria. The Investigator will maintain a screening log to 
record details of all patients screened and to confirm eligibility or record reasons for 
screening failure, as applicable. 
• Procedures conducted as part of the patient’s routine clinical management (eg, blood 
count, local BK viral load, etc.) and obtained before signing of the 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. 
• At the discretion of the Investigator, and with the exception of Weeks 8 and 12 (which 
must be conducted at the site), study visits for patients who have undetectable BK plasma 
viral load at 2 or more consecutive assessments at least 2 weeks apart after 3 doses may 
be conducted by a Sponsor-approved home health vendor in conjunction with a Sponsor-
approved telehealth provider. These visits may be conducted via video or telephone call. 
• For all patients, at the discretion of the Investigator, study visits after Week 12 may be 
conducted by a Sponsor-approved home health vendor in conjunction with a Sponsor-
approved telehealth provider. These visits may be conducted via video or telephone call. 
• 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 maximum amount of blood collected from each patient over the duration of the study 
is outlined in the laboratory manual. 
• Repeat or unscheduled samples may be taken for safety reasons or for technical issues 
with the samples. 
8.1 
Efficacy Assessments 
Planned time points for all efficacy assessments are provided in the SoA. 
8.1.1 
Viral Load 
In patients with concomitant viral infections at the time of treatment, peripheral blood and, where 
relevant, urine, will be monitored for BKV, CMV, AdV, EBV, JCV, and/or HHV-6 viral load 
(see Section 1.3). Resolution of viral infection will be defined as a return to undetectable as 
defined by the assay used and complete resolution of clinical signs and symptoms as determined 
by the Investigator. Viral load will be quantitated using polymerase chain reaction assays. 

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Samples for viral sequence/genotype will be collected on all patients as indicated in Section 1.3. 
8.1.2 
Estimated Glomerular Filtration Rate 
Estimated glomerular filtration rate will be calculated from serum creatinine using the MDRD 
equation. 
8.1.3 
Human Leukocyte Antigen Antibodies 
Human leukocyte antigen antibodies will be assessed using a flow cytometric method. 
8.2 
Safety Assessments 
Planned time points for all safety assessments are provided in the SoA in Section 1.3. 
8.2.1 
Physical Examinations 
• A complete physical examination will include, at a minimum, assessments of the 
cardiovascular, respiratory, gastrointestinal, and neurological systems. A targeted 
physical examination will include careful skin examination for GVHD, and other systems 
as clinically indicated. 
• 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 performed by the 
Investigator or another qualified member of the site’s study team. New abnormal physical 
examination findings must be documented and will be followed by a physician or other 
qualified staff at the next scheduled visit. 
8.2.2 
Vital Signs 
• Temperature, pulse rate, respiratory rate, pulse oximetry, 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. 
• Vital signs will be measured in a semi-supine position after 5 minutes rest and will 
include temperature, systolic and diastolic blood pressure, pulse, and respiratory rate.  
• For visits with infusions, vital signs will be measured within 30 minutes prior to infusion, 
at the end of the infusion, and at 15, 30, 45, and 60 (±5) minutes after the end of the 
infusion. 
8.2.3 
Electrocardiograms 
Single 12-lead electrocardiograms (ECGs) will be obtained with the patient in a semi-supine 
position after a 5-minute rest, as outlined in the SoA (see Section 1.3). The ECG machine will be 
one that automatically calculates the heart rate and measures PR, QRS, QT, and QTc (corrected 
using Fredericia’s and Bazett’s methods) intervals.  

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8.2.4 
Clinical Safety Laboratory Assessments 
• See Appendix 2 (Section 10.2) for the list of clinical laboratory tests to be performed and 
the SoA (Section 1.3) for the timing and frequency. 
• 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 patient’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 treatment 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 patient management or are 
considered clinically significant by the Investigator (eg, SAE or AE or dose 
modification), then the results must be recorded. 
8.2.5 
Pregnancy Testing 
A serum pregnancy test will be performed at screening for all patients of childbearing potential. 
A urine pregnancy test will be performed monthly for patients who are of childbearing potential. 
See Section 1.3. 
8.2.6 
Suicidal Ideation and Behavior Risk Monitoring 
This section is not applicable. 
8.3 
Adverse Events, Serious Adverse Events, and Other Safety Reporting 
The definitions of AEs and SAEs can be found in Appendix 3 in Section 10.3. 
The definitions of unsolicited and solicited AEs can be found in Appendix 3 (Section 10.3). 
Adverse events will be reported by the patient (or, when appropriate, by a caregiver, surrogate, 
or the patient’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 AEs that are serious, considered related to the study treatment or study procedures, or that 
caused the patient to discontinue study treatment (see Section 7). 

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The method of recording, evaluating, and assessing causality of AEs and SAEs and the 
procedures for completing and transmitting SAE reports are provided in Appendix 3 
(Section 10.3). 
8.3.1 
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 
randomization until study participation is complete. 
Medical occurrences that begin before randomization but after obtaining informed consent 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, including a death, at any 
time after a patient has been discharged from the study, and he/she considers the event to be 
reasonably related to the study treatment or study participation, the Investigator must promptly 
notify the Sponsor. 
8.3.2 
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 patient is the preferred method to inquire about 
AE occurrences. 
8.3.3 
Follow-up of AEs and SAEs 
After the initial AE/SAE report, the Investigator is required to proactively follow each patient at 
subsequent visits/contacts. All SAEs and AEs of special interest (as defined in Section 8.3.7), 
will be followed until resolution, stabilization, the event is otherwise explained, or the patient is 
lost to follow-up (as defined in Section 7.3). Further information on follow-up procedures is 
provided in Appendix 3 (Section 10.3). 
8.3.4 
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 patients and the safety of a 
study treatment 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 treatment 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 

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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 SUSARs according to local regulatory 
requirements and Sponsor policy and forwarded to Investigators as necessary. 
8.3.4.1 
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 
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. 
8.3.5 
Pregnancy 
• Details of all pregnancies in female patients and female partners of male patients will be 
collected after the start of study treatment and until 90 days after the last dose of study 
treatment. 
• 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 
pregnancy of the female patient or female partner of a male patient (after obtaining the 
necessary signed informed consent from the female partner). 
• 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 female patient or pregnant female partner of a male patient will be followed to 
determine the outcome of the pregnancy. The Investigator will collect follow-up 
information on the female patient or pregnant female partner of a male patient and the 
neonate and the information will be forwarded to the Sponsor. 
• Any post-study pregnancy-related SAE considered reasonably related to the study 
treatment by the Investigator will be reported to the Sponsor as described in 
Section 8.3.4. While the Investigator is not obligated to actively seek this information in 

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former study female patients or pregnant female partners of a male patients, he or she 
may learn of an SAE through spontaneous reporting. 
• Should a female patient become pregnant during the course of a study, under certain 
circumstances the study design may allow for the continuation of study treatment. In 
these instances, International Council on Harmonisation (ICH) Guidelines and local 
regulations must be observed, and appropriate justification given in Section 4.2. In the 
absence of such justification female patients who become pregnant must be discontinued 
from study treatment. 
Prior to continuation of study treatment following pregnancy, the following must occur: 
• The Sponsor and the relevant IRB/IEC give written approval. 
• The patient gives signed informed consent. 
• The Investigator agrees to monitor the outcome of the pregnancy and the status of the 
patient and her offspring. 
8.3.6 
Cardiovascular and Death Events 
This section is not applicable. 
8.3.7 
Adverse Events of Special Interest 
Adverse events of special interest (AESI) include infusion-related AEs, GVHD, and CRS. 
Grading criteria for GVHD and CRS can be found in Appendix 5 (Section 10.5) and Appendix 6 
(Section 10.6), respectively. These AESIs will be reviewed by the DSMB as per the DSMB 
Charter. 
8.3.7.1 
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 
administration or cumulatively (accidentally or intentionally), which is above the maximum 
recommended dose according to the protocol. Clinical judgement should always be applied. 
In cases of a discrepancy in the drug accountability, overdose will be established only when 
it is clear that the patient has received additional dose(s) or the Investigator has reason to 
suspect that the patient has received additional dose(s). 
• Misuse: Refers to situations where the medicinal product is intentionally and inappropriately 
used in a way that is not in accordance with the protocol instructions or local prescribing 
information and may be accompanied by harmful physical and/or psychological effects.  
• Abuse: Is defined as persistent or sporadic, intentional excessive use of a medicinal product, 
which is accompanied by harmful physical or psychological effects. 
• Medication error: Is any unintentional error in the prescribing, dispensing, or administration 
of a medicinal product by a healthcare professional, patient, or consumer, respectively. The 
administration or consumption of the unassigned treatment and administration of an expired 

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product are always reportable as medication errors; cases of patients missing doses of 
investigational product are not considered reportable as medication errors. 
• Product complaint: Is defined as any written, electronic, or oral communication that alleges 
deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or 
performance of a drug or device after it is released for distribution. A Special Situations 
Report Form will only be completed if a complaint is associated with an adverse drug 
reaction.  
All special situation events as described above must be reported on the Special Situations Report 
Form and faxed/emailed to 
 (contact information listed below) within 24 hours of 
knowledge of the event. All AEs associated with the Special Situations Report Form should be 
reported as AEs or SAEs as well as recorded on the AE eCRF and/or the SAE report form. 
Details of the symptoms and signs, clinical management, and outcome should be provided, when 
available. 
Safety Contact Information:  
 
  
  
 
 
8.4 
Pharmacokinetics 
Pharmacokinetic parameters are not evaluated in this study. 
8.5 
Genetics and/or Pharmacogenomics 
Genetics are not evaluated in this study. 
8.6 
Biomarkers 
Collection of biological samples for biomarker research is also part of this study. Urine samples 
for biomarker research are required and will be collected from all patients in this study as 
specified in the SoA (Section 1.3). 
8.7 
Immunogenicity Assessments 
Immunogenicity assessments are not evaluated in this study. 
8.8 
Medical Resource Utilization and Health Economics 
Medical Resource Utilization and Health Economics parameters are not evaluated in this study. 

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9 
STATISTICAL CONSIDERATIONS 
9.1 
Statistical Hypotheses 
No formal hypothesis testing is planned for this study. 
9.2 
Sample Size Determination 
Note: “Enrolled” patients are those who have been randomized to a treatment arm.  
 
No formal sample size determination was made for this study, whose primary endpoint is safety 
and tolerability. Approximately 60 patients will be randomized at approximately 38 clinical sites. 
Patients (n=20 in each arm) will be randomized to receive PSL 
 
 or placebo. 
Sample size estimates are based on a one-sided test at the 0.05 level to detect suppression of viral 
load to undetectable levels based on the viral load data from the CHARMS study of multivirus-
specific T cells for patients with a plasma BK viral load <2000 copies/mL. 
 
Patients will be stratified by screening BK viral load at randomization to ensure equal 
randomization among active and placebo arms for patient populations 
 
 
 
 A minimum of 6 patients must be enrolled in each stratum, but the 
remaining patients can be enrolled in either stratum. 
9.3 
Analysis Sets 
For the purposes of analysis, the following analysis sets are defined: 
Population 
Description 
Intent-to-Treat (ITT) 
All randomized patients regardless of whether the patient 
receives PSL or placebo. Patients will be analyzed according to 
the randomized study treatment. 
Safety 
All randomized patients who receive PSL or placebo. All safety 
analyses will be based on the Safety Population. Patients will be 
analyzed according to the treatment actually received. 
9.4 
Statistical Analyses 
The SAP will be finalized prior to database lock, and it will include a more technical and detailed 
description of the statistical analyses described in this section. This section is a summary of the 
planned statistical analyses of the most important endpoints including primary and key secondary 
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9.4.1 
General Considerations 
Summary statistics will be presented by treatment group. Unless otherwise stated, continuous 
variables will be summarized using the number of non-missing observations, arithmetic mean, 
standard deviation, median, minimum, and maximum values as descriptive statistics. Categorical 
variables will be summarized using the frequency count and the percentage of patients in each 
category as descriptive statistics. 
9.4.2 
Primary Endpoint(s) 
The primary endpoint is safety and tolerability, as assessed by a qualitative analysis of -treatment 
emergent adverse events (TEAEs) and changes in vital signs, physical examinations, clinical 
laboratory assessments, and ECGs. 
9.4.3 
Secondary Endpoints 
The key secondary endpoint is change in BK viremia in patients receiving PSL compared to 
patients receiving placebo, based on quantitation of viremia performed at the central laboratory. 
9.4.4 
Tertiary/Exploratory Endpoint(s) 
Exploratory continuous and categorical efficacy endpoints will be summarized descriptively by 
treatment group and dose cohort using the Intent-to-Treat (ITT) Population. Categorical 
endpoints will be summarized using number and percentage of patients within each category. For 
time-to-event variables, the Kaplan-Meier method will be used to estimate the median time 
(days) and its 95% confidence interval. 
9.4.5 
Safety Analysis 
All safety data will be summarized by treatment arm actually received. Categorical endpoints 
will be summarized using number and percentage of patients within each category. Continuous 
endpoints will be summarized descriptively with summary statistics (number, mean, standard 
deviation, standard error, median, first quartile, third quartile, minimum, and maximum). 
Adverse events will be coded using the Medical Dictionary for Regulatory Activities. A TEAE is 
defined as an AE with a start date and time on or after the first dose of study treatment and 
through the Week 24 visit. Treatment-emergent AEs 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 relationship to study 
treatment. The incidence of SAEs will be summarized. 
The incidence of AESIs including acute GVHD, CRS, infusion reactions and their corresponding 
exact binomial confidence intervals with 95% confidence level will be presented by treatment 
group. Grading criteria for GVHD and CRS are in Appendix 5 in Section 10.5 and Appendix 6 in 
Section 10.6, respectively. 
Descriptive statistics will be provided for relevant laboratory, vital sign, and ECG data. 
Abnormal laboratory results will be graded according to NCI CTCAE v5.0, if applicable. A shift 
table, 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. 

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Clinical safety laboratory parameters will be presented in summary tables. Changes from 
baseline in laboratory parameters, vital sign parameters, and quantitative ECG parameters will be 
summarized. Selected laboratory parameters will be summarized in shift tables. 
Statistical comparisons will be carried out using Fisher’s exact test and Student’s t test. A 1-sided 
P < .05 will be considered statistically significant. Key secondary outcomes such as BK viral load 
assessments and change in eGFR (measured by comparing the slope of decline in the eGFR over 
time) between the placebo group and treatment group will be analyzed using the statistical 
comparisons described above. The baseline demographics of patients, such as age and gender, 
etc., will also be analyzed to ensure adequate randomization. 
9.4.6 
Other Analyses 
In addition to the endpoints described previously, the following endpoints may be analyzed: 
• Frequency and severity (adjudicated Banff classification) of biopsy-proven acute 
allograft rejection in recipients of PSL versus placebo. 
• Number of patients in the investigational arms with polyomavirus haufen in the urine as 
compared to the placebo arm. 
• Quantification of IFN-ɣ (+) T cells specific for BK virus in patients in the investigational 
arms as compared to the placebo arm. 
• Levels of (virus-specific T cell) donor T cell deoxyribonucleic acid (DNA) as compared 
to patient T cell DNA in peripheral blood. 
• Time to resolution of non-BK target viral infections (ie, associated signs, symptoms, and 
presence/absence of HHV-6, EBV, JCV, and/or AdV viremia) present at the time of 
randomization. 
• Use of immunosuppressive agents, including specific immunosuppressive agents used, 
dosed, and any changes in dose. 
• Number of hospitalizations/re-hospitalizations for any reason and number of days. 
• Incidence and duration of use of any other antiviral therapies during the study. 
• Time to death (from any cause) from the time of randomization. 
• Number of patients with kidney injury requiring hemodialysis.  
• Rate of decline of BK viremia in recipients of PSL using different dosing intervals versus 
that in patients receiving placebo. 
• Assessment of renal function (eGFR estimated by the creatinine-cystatin C method). 
Details of these analyses are provided in the SAP. 
9.5 
Interim Analyses 
Administrative interim analyses are planned for the study. The Sponsor’s study team and 
Investigators will remain blinded to individual patient data during and after the administrative 
interim analyses. All administrative interim analyses will be conducted by the Sponsor. 

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• The first administrative interim analysis will be performed by the Sponsor when 12 
patients in Stratum 1 
 have 
completed 8 weeks in the study. 
• The second administrative interim analysis will be performed when 30 patients have 
completed 8 weeks in the study. 
• Interim analyses may be omitted or added at the discretion of the Sponsor to allow for 
long term planning, and to assess ending the study or either arm early. 
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.  
No patients will be permitted to receive a second infusion of PSL or placebo if they develop new 
onset GVHD ≥Stage 1 or CRS Grade 2 at the proposed time of infusion of any subsequent 
dose. 
After the first 3 doses, patients who have undetectable BK plasma viral load at 2 or more 
consecutive assessments at least 2 weeks apart will discontinue PSL infusions. 
9.5.1.2 
Stopping Criteria for the Study 
Randomization into the study will be halted if 3 patients experience SAEs that meet the 
following criteria: 
• ≥CTCAE Grade 3, 
• Considered related by the Investigator, 
• Occur during Period 1 following the initial dose, AND 
• Cannot be reasonably attributed to the patient’s underlying disease, other medical 
condition, or concomitant medications. 
If this occurs, randomization will not resume until the DSMB has thoroughly reviewed all safety 
data to date and concluded that it is safe for the study to continue. 

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10 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
10.1 
Appendix 1: Regulatory, Ethical, and Study Oversight Considerations 
10.1.1 
Regulatory and Ethical Considerations 
• This study will be conducted in accordance with the protocol and with the following: 
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 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 patients.  
• 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 patients. 
• 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. 

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10.1.3 
Informed Consent Process 
• The Investigator or his/her representative will explain the nature of the study to the 
patient and answer all questions regarding the study. 
• Patients must be informed that their participation is voluntary. Patients 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 patient 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. 
• Patients 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 patient. 
10.1.4 
Data Protection 
• Patients will be assigned a unique identifier by the Sponsor. Any patient records or 
datasets that are transferred to the Sponsor will contain the identifier only; patient names 
or any information which would make the patient identifiable will not be transferred. 
• The patient 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 patient who will be required to give consent for their data to be used 
as described in the informed consent  
• The patient 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 
Data Safety and Monitoring Board 
An independent DSMB will be convened for this study to routinely monitor patient safety and 
evaluate prespecified interim analyses to stop the study or either arm early. The DSMB will 
receive summary reports of all unexpected SAEs. A DSMB charter, detailing all aspects of the 
DSMB’s composition, scope of review, and procedures will be provided in a separate document. 
In addition, the DSMB will review safety data after the first 3 patients enrolled have received 
their 3rd dose.  
An unblinded statistician will be assigned to the DSMB. This statistician will not be involved in 
any aspects of study conduct outside of the DSMB, and their role will be defined in the DSMB 
charter. 
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 

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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 patient data relating to the study will be recorded on printed or eCRF 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 case report form (CRF). 
• The Investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents. 
• 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 patient and substantiate the 
integrity of the data collected. Source documents are filed at the Investigator’s site. 
• 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. 
• 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, complete, and verifiable from 
source documents; that the safety and rights of patients are being protected; and that the 

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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 
First Act of Recruitment 
The study start date is the date on which the clinical study will be open for recruitment of 
patients. 
The first act of recruitment is the first patient randomized, and will be the study start date. 
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 treatment 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 patients by 
the Investigator 
• Total number of patients included earlier than expected 
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 patient and 
should assure appropriate patient 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. 

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10.2 
Appendix 2: Clinical Laboratory Tests 
• The tests detailed in Table 4 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 treatment 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 treatment decision or response evaluation, the results must be 
recorded. 
• Protocol-specific requirements for inclusion or exclusion of patients 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. 

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Table 4 
Protocol-Required Safety Laboratory Tests 
Laboratory Tests 
Parameters 
Hematology 
Platelet count  
RBC Indices: 
MCV 
MCH 
%Reticulocytes 
White blood cell (WBC) 
count with differential: 
Neutrophils 
Lymphocytes 
Monocytes 
Eosinophils 
Basophils 
Red blood cell (RBC) count 
Hemoglobin 
Hematocrit 
Clinical Chemistry 
Blood urea 
nitrogen (BUN) 
Potassium 
Aspartate aminotransferase 
(AST)/Serum glutamic-
oxaloacetic transaminase (SGOT) 
Total and direct 
bilirubin 
 
Creatinine 
Sodium 
Alanine aminotransferase 
(ALT)/Serum glutamic-pyruvic 
transaminase (SGPT) 
Total Protein 
 
Glucose, 
nonfasting  
Calcium 
Alkaline phosphatase 
Cystatin C 
 
Chloride 
Gamma-
glutamyl 
transferase 
 
Lactate dehydrogenase 
Uric acid 
 
 
Albumin 
Amylase 
Bicarbonate 
Creatine kinase 
 
Inorganic 
phosphorus 
Lipase 
 
 
Plasma Viral load 
Adenovirus 
BK virus 
Cytomegalovirus 
Epstein-Barr virus 
(in PBMCs) 
 
Human 
herpesvirus 6 
JC virus 
 
 
 
 
 
 
 
Routine Urinalysis 
• Specific gravity 
• pH, glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase 
by dipstick 
• Microscopic examination (if blood or protein is abnormal) 
Pregnancy Testing 
• Highly sensitive serum human chorionic gonadotropin (hCG) pregnancy test (as needed 
for women of childbearing potential) 
Other Tests 
• Follicle-stimulating hormone and estradiol (as needed in women of non-childbearing 
potential only) 
• Serology (human immunodeficiency virus [HIV] antibody, hepatitis B surface antigen 
[HBsAg], and hepatitis C virus antibody) along with confirmatory tests if requested 
• All study-required laboratory tests will be performed by a central laboratory, with the 
exception of the following tests that will be shipped to the central lab and then sent to 
specialty labs: 
o Urinary haufen 
o Donor specific antibodies 
o Testing of banked peripheral blood mononuclear cells (PBMCs) for virus specific 
immunity  
o Testing of banked PBMCs for donor DNA 
Investigators must document their review of each laboratory safety report. 
 

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within 24 hours of awareness. When the EDC system becomes available, the SAE 
information must be entered within 24 hours of the system becoming available. 
• Initial notification via telephone does not replace the need for the Investigator to 
complete and sign the SAE data collection tool within the designated reporting time 
frames. 
• Contacts for SAE reporting can be found in Section 8.3.7.1. 
 
 

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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 patient’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 treatment, 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 

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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 patient’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 FSH level in the postmenopausal range may be used to confirm a 
postmenopausal state in women not using hormonal contraception or 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. 

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10.4.2 
Contraception Guidance 
CONTRACEPTIVES
a ALLOWED DURING THE STUDY INCLUDE: 
Highly Effective Methodsb 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 ovulation c  
• Intrauterine device (IUD) 
• Intrauterine hormone-releasing system (IUS) c 
• 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 patient can come from the site personnel’s review of the 
patient’s medical records, medical examination, or medical history interview.) 
Highly Effective Methodsb 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 ovulationc 
− oral 
− intravaginal 
− transdermal 
− injectable 
Progestogen-only hormone contraception associated with inhibition of ovulation c 
− 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 treatment. 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 patient.) 
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)e 
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.) 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). 

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10.5 
Appendix 5: Graft Versus Host Disease Scales 
Table 5 
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 
3-4 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 5-7 
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. 
Abbreviations:  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. 

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Table 6 
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. 
Abbreviations:  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.  
 
 

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10.6 
Appendix 6: Cytokine Release Syndrome Scale 
Table 7 
Cytokine Release Syndrome Scale 
 
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) 
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. 
Abbreviations:  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. 
 
 

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10.7 
Appendix 7: Modification of Immunosuppression 
NOTE: *Viral load determinations that would lead to changes in immunosuppression (red boxes) should be repeated immediately upon receipt to confirm that action should be 
taken as indicated. 
a If MMF has already been reduced or discontinued more than 28 days prior, proceed to the next step in the algorithm. Other variations from the algorithm require consultation 
with, and approval by, the Sponsor’s Medical Monitor. 
b Triple Immunosuppression: low-dose oral steroids, MMF, and calcineurin inhibitor. 
c Double Immunosuppression: MMF and calcineurin inhibitor. 
Abbreviations:  AST = American Society of Transplantation; KDIGO = Kidney Disease: Improving Global Outcomes; MMF = mycophenolate mofetil; PCR = polymerase chain 
reaction; PI = Principal Investigator (ie, Investigator); Q =e very; VL = viral load 
 

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11 
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