A Phase I/II Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma
Phase: PHASE1
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Altor BioScience

CLINICAL STUDY PROTOCOL 
Protocol Number: 
CA-ALT-803-02-13 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed 
or Refractory Multiple Myeloma 
Date of Protocol: 
Version# 01 
January 7, 2014 
Sponsor Contact: 
Hing C. Wong, Ph.D. 
Altor Bioscience Corporation. 
Miramar, Florida 33025 
Telephone: 
954-443-8600
Safety Data Fax: 
954-443-8602

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 3 of 65 
 
 
Table of Contents 
SYNOPSIS ................................................................................................................................................................6 
1. 
OBJECTIVES ................................................................................................................................................12 
1.1 
PRIMARY OBJECTIVES .............................................................................................................................12 
1.2 
SECONDARY OBJECTIVES ........................................................................................................................12 
2. 
BACKGROUND ............................................................................................................................................12 
2.1 
ALT-803 – GENERAL INFORMATION.......................................................................................................12 
2.2 
MULTIPLE MYELOMA .............................................................................................................................13 
2.3 
IMMUNE-BASED THERAPIES FOR CANCER ...............................................................................................13 
2.4 
PHARMACOLOGICAL EFFECTS OF ALT-803 IN VITRO AND IN ANIMALS ..................................................14 
 
Development of ALT-803 (IL-15N72D:IL-15RαSu/IgG1 Fc complex) .............................................................. 14 
2.4.1
 
In vitro biological activity of ALT-803 ............................................................................................................... 15 
2.4.2
 
In vivo biological activity of ALT-803 ............................................................................................................... 15 
2.4.3
 
Potent anti-tumor activity of ALT-803 in mouse models .................................................................................... 16 
2.4.4
 
Anti-myeloma mechanism of action of ALT-803 ................................................................................................ 17 
2.4.5
2.5 
NON-CLINICAL TOXICOLOGY ..................................................................................................................17 
 
Multi-dose toxicity studies in mice ..................................................................................................................... 17 
2.5.1
 
Multi-dose toxicity studies in cynomolgus monkeys ........................................................................................... 18 
2.5.2
2.6 
PHARMACOKINETICS ...............................................................................................................................19 
 
Non-clinical pharmacokinetics .......................................................................................................................... 19 
2.6.1
 
Clinical pharmacokinetics ................................................................................................................................. 20 
2.6.2
2.7 
RATIONALE FOR HUMAN CLINICAL STARTING DOSE ...............................................................................20 
2.8 
HUMAN EXPERIENCE ...............................................................................................................................20 
3. 
RATIONALE FOR THE CURRENT STUDY ...........................................................................................21 
4. 
OVERALL STUDY DESIGN .......................................................................................................................22 
5. 
STUDY POPULATION ................................................................................................................................24 
5.1 
INCLUSION CRITERIA ...............................................................................................................................24 
5.2 
EXCLUSION CRITERIA ..............................................................................................................................25 
5.3 
INCLUSION OF WOMEN AND MINORITIES .................................................................................................25 
6. 
STUDY DESIGN ...........................................................................................................................................26 
6.1 
STUDY FLOW DIAGRAM ...........................................................................................................................26 
6.2 
SCREENING AND ENROLLMENT ...............................................................................................................26 
6.3 
STUDY TREATMENT .................................................................................................................................26 
 
Treatment setting ............................................................................................................................................... 27 
6.3.1
 
Treatment regimen and study scheme ................................................................................................................ 27 
6.3.2
 
Study drug preparation ...................................................................................................................................... 27 
6.3.3
 
Study drug administration .................................................................................................................................. 27 
6.3.4
 
Pre and post-therapy intervention guidelines .................................................................................................... 28 
6.3.5
6.4 
DURATION OF PATIENT PARTICIPATION ..................................................................................................29 
6.5 
DOSE ESCALATION PHASE .......................................................................................................................29 
6.6 
EXPANSION PHASE ..................................................................................................................................30 
6.7 
STOPPING RULES .....................................................................................................................................31 
 
During dose escalation phase of the study ......................................................................................................... 31 
6.7.1
 
During expansion phase of the study ................................................................................................................. 31 
6.7.2
 
At any time during the study .............................................................................................................................. 31 
6.7.3
6.8 
PATIENT MONITORING, RESPONSE EVALUATION, DISEASE PROGRESSION & SURVIVAL FOLLOW-UP .....32 
 
Patient monitoring ............................................................................................................................................. 32 
6.8.1
 
Response evaluation ........................................................................................................................................... 32 
6.8.2
 
Disease progression and survival follow-up ...................................................................................................... 32 
6.8.3

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 4 of 65 
 
6.9 
DOSE LIMITING TOXICITY ........................................................................................................................32 
 
Definition of dose limiting toxicity ..................................................................................................................... 32 
6.9.1
 
Definition of maximum tolerated dose (MTD) ................................................................................................... 33 
6.9.2
 
Definition of minimal efficacious dose (MED) .................................................................................................. 33 
6.9.3
6.10 
STUDY TREATMENT DISCONTINUATION ..................................................................................................33 
 
Study treatment discontinuation events ......................................................................................................... 33 
6.10.1
 
Replacement of participants .......................................................................................................................... 33 
6.10.2
 
Follow-ups after treatment discontinuation .................................................................................................. 34 
6.10.3
6.10.3.1. 
Discontinuation due to SAEs or on-going study drug related AEs .......................................................... 34 
6.10.3.2. 
Discontinuation due to any other reasons ................................................................................................. 34 
6.11 
STUDY TREATMENT INTERRUPTION ........................................................................................................34 
 
Kidney dysfunction ........................................................................................................................................ 34 
6.11.1
 
Hematological dysfunction ............................................................................................................................ 34 
6.11.2
 
Hypotension .................................................................................................................................................. 34 
6.11.3
 
Allergic reactions and cytokine release syndrome/acute infusion reaction .................................................. 35 
6.11.4
6.12 
GENERAL SUPPORTIVE CARE GUIDELINES AND DRUG INTERACTION ......................................................35 
 
Hypotension and capillary leak syndrome .................................................................................................... 35 
6.12.1
 
Pulmonary dysfunction .................................................................................................................................. 36 
6.12.2
 
Impaired kidney and liver functions .............................................................................................................. 36 
6.12.3
 
Infection ........................................................................................................................................................ 36 
6.12.4
 
Fever and chills ............................................................................................................................................. 36 
6.12.5
 
Gastritis ......................................................................................................................................................... 36 
6.12.6
 
Diarrhea, nausea and vomiting ..................................................................................................................... 36 
6.12.7
 
Pruritus and dermatitis ................................................................................................................................. 36 
6.12.8
 
Acidosis ......................................................................................................................................................... 36 
6.12.9
 
Life-threatening toxicities ............................................................................................................................. 36 
6.12.10
 
Other supportive care ................................................................................................................................... 36 
6.12.11
 
Drug interaction ............................................................................................................................................ 36 
6.12.12
7. 
STUDY DRUG: AVAILABILITY, ACCOUNTABILITY, PACKAGING & LABELING ...................38 
7.1 
AVAILABILITY .........................................................................................................................................38 
7.2 
ACCOUNTABILITY ...................................................................................................................................38 
7.3 
PACKAGING .............................................................................................................................................38 
7.4 
LABELING ................................................................................................................................................38 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS ................................................................39 
8.1 
STUDY CALENDAR ...................................................................................................................................39 
8.2 
PROCEDURE AND TESTS ..........................................................................................................................40 
 
Assays for immune cell levels and phenotype .................................................................................................... 40 
8.2.1
 
Medical history & prior therapy ........................................................................................................................ 40 
8.2.2
 
Pregnancy test .................................................................................................................................................... 40 
8.2.3
 
Physical examination ......................................................................................................................................... 40 
8.2.4
 
Vital signs, body weight & height ...................................................................................................................... 40 
8.2.5
 
Cardiac assessment ............................................................................................................................................ 40 
8.2.6
 
Pulmonary function monitoring ......................................................................................................................... 40 
8.2.7
 
Clinical blood tests ............................................................................................................................................ 41 
8.2.8
 
Disease assessment tests and procedures .......................................................................................................... 41 
8.2.9
 
Adverse event assessment .............................................................................................................................. 41 
8.2.10
 
Response assessment ..................................................................................................................................... 41 
8.2.11
 
Disease progression and survival follow-up ................................................................................................. 41 
8.2.12
 
Pharmacokinetic (PK) testing ....................................................................................................................... 42 
8.2.13
 
Biomarker assays for IL-2, IL-4, IL-6, IL-10, IFN- and TNF- .................................................................. 42 
8.2.14
 
Immunogenicity tests - detection of anti-ALT-803 antibodies ....................................................................... 42 
8.2.15
9. 
MEASUREMENT OF EFFECT ..................................................................................................................43 
9.1 
MEASURABLE DISEASE ............................................................................................................................43 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 5 of 65 
 
9.2 
EFFECT ASSESSMENT SCHEDULE .............................................................................................................43 
9.3 
METHODOLOGY OF RESPONSE EVALUATION ..........................................................................................43 
9.4 
RESPONSE EVALUATION CRITERIA ..........................................................................................................44 
9.5 
DISEASE PROGRESSION EVALUATION CRITERIA ......................................................................................45 
10. 
STATISTICAL ANALYSIS .....................................................................................................................46 
10.1 
STUDY OBJECTIVES .................................................................................................................................46 
10.2 
SAMPLE SIZE ............................................................................................................................................46 
10.3 
DATA COLLECTION ..................................................................................................................................46 
10.4 
DATA ANALYSIS ......................................................................................................................................46 
 
Analysis of safety ........................................................................................................................................... 47 
10.4.1
 
Analysis of response ...................................................................................................................................... 47 
10.4.2
 
Pharmacokinetics .......................................................................................................................................... 47 
10.4.3
11. 
REGULATORY AND REPORTING REQUIREMENTS ....................................................................48 
11.1 
ADVERSE EVENTS RECORDING, REPORTING AND COMMUNICATION .......................................................48 
11.2 
ADVERSE EVENT TERMINOLOGY AND DEFINITIONS ................................................................................48 
11.3 
ADVERSE EVENT REPORTING PROCEDURES ...........................................................................................49 
11.4 
ADVERSE EVENT EXPEDITED REPORTING GUIDELINES ..........................................................................50 
11.5 
SUBMISSION OF SERIOUS ADVERSE EVENT REPORTING ...........................................................................50 
11.6 
DATA REPORTING FORMS .......................................................................................................................50 
11.7 
REPORT /DATA SUBMISSION ADDRESS & CONTACT ................................................................................51 
11.8 
PATIENT RECORDS, QUALITY ASSURANCE, RECORDS RETENTION ..........................................................51 
11.9 
METHOD OF REVIEW ...............................................................................................................................51 
11.10 
SPECIAL REGULATORY CONSIDERATIONS ...........................................................................................52 
 
HIPAA ........................................................................................................................................................... 52 
11.10.1
 
Protocol amendments, informed consent, and IRB approval ........................................................................ 52 
11.10.2
12. 
CONFIDENTIALITY ...............................................................................................................................52 
13. 
ETHICAL STANDARDS & INVESTIGATOR OBLIGATIONS .......................................................52 
14. 
LIST OF EXPECTED ADVERSE EVENTS ..........................................................................................53 
15. 
CTCAE .......................................................................................................................................................55 
REFERENCES .......................................................................................................................................................56 
APPENDIX A: ECOG ...........................................................................................................................................58 
APPENDIX B: NEW YORK HEART ASSOCIATION CLASSIFICATION .................................................58 
APPENDIX C: ETHICAL STANDARDS ...........................................................................................................59 
APPENDIX D: INVESTIGATOR OBLIGATIONS ...........................................................................................60 
APPENDIX E: CONTACT LIST - ALTOR ........................................................................................................64 
APPENDIX F: CONTACT LIST – DATA SAFETY MONITORING BOARD (DSMB) ...............................65 
APPENDIX G: CONTACT LIST - LABORATORIES......................................................................................65 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 6 of 65 
SYNOPSIS 
Sponsor: 
Altor Bioscience Corporation 
Protocol#: 
CA-ALT-803-02-13 
Study Drug Name: Not applicable 
Study Treatment 
Active agents: 
ALT-803, a “recombinant human super agonist interleukin-15 (IL-15) complex” 
(AKA, IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
Study Type: 
Interventional 
Study Phase: 
Ib/II 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed or Refractory Multiple Myeloma 
Objectives: 
To evaluate the safety and tolerability of escalating doses, identify the Maximum 
Tolerated Dose level (MTD) or Minimum Efficacious Dose (MED) and designate 
a dose level for Phase II study (RP2D) of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
 
To evaluate the effect of ALT-803 on the peripheral absolute lymphocyte counts 
(ALC) and white blood cell (WBC) counts, the number and phenotype of 
peripheral blood T (total and subsets) and NK cells. 
To estimate the anti-tumor activity of ALT-803 by radiologic or pathologic disease 
response, progression free survival, and overall survival in treated patients.  
To characterize the immunogenicity and pharmacokinetic profile, including serum 
levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-803 in treated 
patients. 
 
Study Design: 
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-
escalation study of ALT-803 in patients with relapsed or refractory multiple 
myeloma. 
 
The study includes a dose escalation phase to determine the MTD or MED using a 
modified classic (3+3) dose escalation design and to designate a dose level for the 
Phase II expansion phase (RP2D) and a two-stage expansion phase at the RP2D 
using a Simon two-stage design. In Phase I, five dose levels will be evaluated. A 
step-down dose level (cohort# -1) will be provided in the event of encountering 
DLT in two patients at the planned initial dose level. In the absence of 
unacceptable toxicity or disease progression, each enrolled patient will receive up 
to four 6-week study treatment cycles, each consisting of a 4-week treatment 
period and a 2-week rest period. In each cycle, patients will receive four doses of 
ALT-803 by intravenous injection weekly for 4 weeks followed by a 2-week rest 
period. Patients with sufficient recovery of toxicities from the previous treatment 
cycles will be eligible to continue study treatment. After receiving two treatment 
cycles, patients who have at least stable disease assessed at week 11-12 may 
receive up to two additional study treatment cycles followed by reassessment for 
continued tumor response. 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 7 of 65 
The study will be conducted in conformity with Good Clinical Practice (GCP).  
 
Treatments:  
The study treatment plan for each enrolled patient includes up to four 6-week study 
treatment cycles. In each cycle, patients will receive four weekly doses of ALT-803 
by intravenous injection followed by a 20-day rest period. The rest period may be 
extended to include up to four additional weeks if necessary. Patients who do not 
experience or who sufficiently recover from toxicities of the previous treatment 
cycles will be eligible to continue the treatment included in the study treatment 
plan. 
Treated patients will have up to two anti-tumor evaluation visits. Patients who 
receive at least three study drug doses during the first 2-cycle treatment period will 
be evaluated for anti-tumor response during week 11-12. Patients who have at least 
stable disease from the first anti-tumor evaluation and who meet other criteria to 
continue study treatment will receive up to two additional study treatment cycles, 
with the same treatment schedule and at the same dose level as the first two cycles, 
followed by reassessment for continued tumor response. 
The study treatment and response evaluation schedule is illustrated below: 
Treatment Cycle 
Cycle #1 
REST 
Cycle #2 
Response 
Evaluation 
Cycle #3 
REST 
Cycle #4 
Response 
Evaluation 
Treatment Week 
1 
2 
3 
4 
5-6 
7 
8 
9 10 
11-12 
13 14 15 16 
17-18 
19 
20 21 22 
23-24 
Treatment Day 
1 
8 
15 22 
23-42 
43 50 57 64 
65-84 
85 92 99 106 107-126 127 134 141 148 149-168 
Dose# 
1 
2 
3 
4 
Rest 
weeks 
5 
6 
7 
8 
 
9 10 11 12 
Rest 
weeks 
13 
14 15 16 
 
Response Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
ALT-803 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
There are no restrictions on further therapies, such as chemotherapy, radiation 
therapy or surgery to be used after the protocol-specified therapy. Clearly, post-
study treatments could be of significant clinical benefit in selected patients, and 
these patients will be followed for outcome. 
Enrolled patients will receive the study treatment at qualified cancer treatment 
centers with adequate diagnostic and treatment facilities to provide appropriate 
management of therapy and complications. ALT-803 will be administered by 
intravenous infusion into a central or peripheral vein under the supervision of a 
qualified physician experienced in the use of biologic anti-cancer agents. 
Dose Escalation 
Phase: 
A modified 3 + 3 design will be used for identifying a tolerable dose for phase II 
studies by monitoring patients for DLTs to determine the MTD and for identifying 
an efficacious dose by monitoring patients’ ALC and WBC count to determine the 
MED during the DLT observation period. The dose escalation phase is concluded 
when either the MTD or the MED is determined. A dose level (RP2D) will then be 
designated for Phase II study. There are five escalating dose levels of ALT-803 
and a step-down cohort (-1) with a lower dose level of ALT-803 in the event that 
unexpected toxicity is encountered at the initial dose level. 
 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 8 of 65 
 
Below are the planned dose levels of the study drug during the dose escalation 
phase of the study.  
 
 
 
 
 
 
  
 
Dose limiting toxicity (DLT) is defined as follows: any study drug related toxicity 
that is of Grade 3 and does not resolve to Grade 1 or lower within a week despite 
the use of medical intervention or that is of Grade 4, with exceptions described in 
the study protocol.  
The DLT Observation Period is defined as the duration of the first treatment cycle. 
 
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out 
of 6 patients experienced DLT and that is one level below a dose that was not 
tolerated. 
 
Minimal Efficacious Dose (MED) is defined as a dose level which produces an 
ALC ≥25,000/µL sustained for 14 days or a total WBC ≥35,000/µL sustained for 
14 days among 2/3 or 4/6 of patients. For safety, we have also defined an 
“exceeding MED” as the occurrence of ALC ≥35,000/µL or WBC ≥50,000/µL 
sustained for 14 days. 
 
Expansion 
Phase 
The two-stage expansion phase at the MTD or the MED level will be conducted 
using an optimal Simon’s two-stage design. Objective response (OR) (defined as 
complete response (CR) + partial response (PR)) will be evaluated and set 
thresholds of lack of efficacy (OR rate (ORR) = 10%) and an efficacy level of 
interest (ORR = 30%) will be selected.  
Stopping Rules: 
Patient enrollment will be temporarily suspended based on occurrence of any of 
the following events, and the study committee, including the sponsor, the Data 
Safety Monitoring Board and principal investigators will meet to discuss how to 
proceed with future patient enrollment in the study. 
During the dose escalation phase of the study,  
 If the maximum planned dose level has been reached, but neither the MTD nor 
MED can be determined. 
Cohort 
ALT-803 Dose (µg/kg) 
Number of patients 
-1 
0.5 
3 to 6 
1 (initial) 
1 
3 to 6 
2 
3 
3 to 6 
3 
6 
3 to 6 
4 
10 
3 to 6 
5 
20 
3 to 6 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 9 of 65 
 If de-escalation occurs and the step-down dose level cannot be designated as 
the MTD or MED.  
Any time during the expansion phase of the study,  
 More than 33% of patients experience a possible, probable or definite study 
drug related DLT. 
 Favorable anti-tumor response data collected from enrolled patients. 
At any time during the study, 
The study committee may meet to discuss how to proceed with the study and may 
make any or all of the following recommendations for further patient enrollment:  
 Downward adjust the study drug dose. 
 Adjust the study drug dosing schedule. 
 Recommend more effective pre-therapy, intra-therapy and post-therapy side 
effect mitigation interventions. 
 Correct protocol technical errors that caused unnecessary dose omissions or 
premature treatment discontinuations. After correction of protocol errors, the 
DSMB may meet to re-evaluate the safety profile of the study treatment and 
recommend how to proceed with the study, if necessary. 
Evaluations: 
Patients will be evaluated for clinical toxicities during the treatment. Patients’ 
blood samples will be collected to assess the pharmacokinetic profile and 
immunogenicity of the study drug. The anti-tumor response will be evaluated at 
week 11-12 and week 23-24 from the start of study treatment. All patients who 
receive at least 3 doses of the study drug ALT-803 will be included in the anti-
tumor response evaluation. 
Population: 
Patients of 18 years of age and above with relapsed or refractory multiple 
myeloma. Patients also need to have adequate cardiac, pulmonary, liver and 
kidney functions and have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0, 1 or 2.  
Sample Size: 
A total of up to 30 assessable patients will be accrued to the dose escalation phase of 
the study (Phase Ib). Anticipated enrollment to this phase is 18 patients. Up to an 
additional 23 assessable patients will be enrolled at the expansion phase (Stage 1 
and 2) of the study (Phase II). A total of approximately 41 assessable patients will 
be enrolled to complete the study. Assuming a 20% rate of ineligible or non-
assessable cases, a total of up to 50 patients may be accrued to the study. 
 
Primary 
Endpoints 
For Phase Ib only 
(1) Determination of the MTD or MED and designation of the recommended dose 
level (RP2D) for Phase II study of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
For Phase Ib & II 
(2) Safety profile of ALT-803 in treated patients. 
 
(3) Disease response rate of treated patients.  
Secondary  

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 10 of 65 
Endpoints 
(1) Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, 
the number and phenotype of peripheral blood T (total and subsets) and NK 
cells in treated patients. 
 
(2) Duration of response in treated patients. 
 
(3) Progression free survival of treated patients. 
(4) Overall survival of treated patients. 
(5) Characterization of the immunogenicity and pharmacokinetic profile, 
including serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-
803 in treated patients. 
Pharmacokinetics 
& Biomarkers: 
Fresh blood samples will be collected to assess immune cell levels and phenotype, 
and serum samples for pharmacokinetics, immunogenicity of the study drug ALT-
803, and the serum levels of IL-2, IL-4, IL-6, IL-10, IFN- and TNF-after ALT-
803 administration in treated patients. Blood samples for pharmacokinetic analysis 
will be taken on the first day of ALT-803 administration in the first study 
treatment cycle. Venous blood will be obtained at Time 0 (before the start of 
infusion), at 30 minutes, and 2, 4, 6 and 24 hours from Time 0 for the assessment 
of ALT-803 serum concentrations. Non-compartmental and compartmental 
analyses will be conducted. In addition, the same blood samples collected for PK 
analysis will be used to assess the serum levels of IL-2, IL-4, IL-6, IL-10, IFN- 
and TNF-. Fresh blood samples for immune cell levels and phenotype testing 
will be collected before the start of first and fourth dose of study drug infusion in 
each treatment cycle. Bone marrow samples will be collected for future analysis of 
molecular markers associated with responses or resistance to ALT-803 in patients 
with relapsed or refractory multiple myeloma. 
Monitoring Tests: Blood samples for standard chemistry and CBC with differential will be obtained 
at screening, on each study drug infusion day, and at follow-up visits. Blood 
samples for immunogenicity testing for anti-ALT-803 antibodies will be collected 
prior to dosing on the first ALT-803 infusion day and at weeks 7 and 12 from the 
initial dose of study treatment. Blood and urine samples will be collected on each 
follow-up visit for response assessment.  
Response 
Assessment: 
There are at least two response assessments for treated patients: the first 
assessment during week 11-12 and the second assessment during week 23-24 from 
the start of study treatment. After completion of the first two cycles of study 
treatment, patients who have received at least 3 doses of study drug will have the 
first response assessment. After completion of the two additional cycles of study 
treatment, patients, regardless of the number of additional study drug doses 
received, will have the second response assessment. Response assessments will be 
carried out according to the new International Uniform Response Criteria for 
Multiple Myeloma proposed by the International Myeloma Working Group. 
Baseline evaluations should be performed up to 14 days before study treatment 
starts.  
Progression & 
Survival 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
               
 
 
 
               January 7, 2014 
Page 11 of 65 
Assessment: 
Progression-free survival, overall survival, and duration of response of all treated 
patients will be assessed every three months during year 1 and then every 6 
months during years 2 and 3 from the start of study treatment, or through the point 
designated as the end of the study follow up. 
Adverse Events: 
All patients will be monitored and evaluated for clinical toxicities during the 
treatment period and queried at each follow-up visit for Adverse Events (AEs). 
Patients may volunteer information concerning AEs. All adverse events will be 
graded by using the NCI Common Terminology Criteria for Adverse Events 
version 4.0 (CTCAE v4.0), and logged in the patient Case Report Form. The study 
centers should report all Serious Adverse Events (SAEs) and all events that trigger 
patient’s study treatment discontinuation to the sponsor via phone, fax or email (or 
a combination) no more than 24 hours after learning of the event. The sponsor will 
use the information to manage and coordinate the dose escalation, cohort 
expansion and patient enrollment. The sponsor will then inform all of the 
participating clinical sites of the current dose level and the number of patients to 
be enrolled at that level, or of any patient enrollment suspension via phone, fax or 
email within 24 hours of learning of the event. The study centers should report all 
other adverse events to the sponsor following the guidelines defined in the study 
protocol. All study drug related AEs that are both serious and unexpected will be 
reported to the FDA in an expedited manner in accordance with 21 CFR §312.32. 
Statistical Plan: 
For each cohort, all AEs will be tabulated and examined and all safety, 
pharmacokinetic and tumor response data will be evaluated. For estimation of 
duration of response and progression free survival, the Kaplan-Meier method will 
be used. P-values of ≤0.05 (two-sided) will be considered to indicate statistical 
significance.  
 
 

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 01 
IND (PIND 114006) SERIAL# 0000 
 
          
 
 
 
 
 
              
 
 
 
     January 7, 2014 
Page 39 of 65 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS 
8.1 
Study calendar 
TESTS & PROCEDURES 
SCREEN/ 
BASELINE1 
TREATMENT 
CYCLE #1 
REST  
TREATMENT 
CYCLE  #2 
1ST RESPONSE 
ASSESSMENT   
TREATMENT CYCLES     
#3 AND #4  
2ND RESPONSE 
ASSESSMENT 
FOLLOW-UPS 
Study Month  
 
1 
 
2 
3 
4-5 
6 
9  
12  
18  
24   30  36   
Study Week  
 
1 
2     3 
4 
5-6 
7  
8 
9 
10 
11-12 
13-22 
23-24 
Any day during the month  
Study Day  
 
1  
8  
15  
22  
23-42 
 43 
50  
57  
 64 
65-84  
85-148 
149-168 
Tolerance Window 
 
+/- 2 days 
23-42 
+/- 2 days 
Any day 
 
Any day 
Medical history 
X 
 
 
 
 
R 
 
E 
 
S 
 
T 
 
 
P 
 
E 
 
R 
 
I 
 
O 
 
R 
 
 
 
 
 
Follow Institution’s 
standard of care (SOC) 
policy.  
If performed, follow the 
same schedule as in the 
first two cycles of study 
treatment. 
 
 
 
Serum pregnancy test2 
X 
 
 
 
 
 
 
 
 
 
 
Complete physical exam 
X 
X 
 
 
 
X 
 
 
 
X 
X 
Vital signs, Weight, Height3, Cardiac & Lung 
function monitoring  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concurrent medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event assessment4 
X 
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC with Differential 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Blood Chemistry  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
EKG 
X 
X5 
 
X 
 
 
 
 
 
PFT only when clinically indicated 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Response evaluation6 
  
  
 
X 
  
X 
 
Serum quantitative immunoglobulins 
X 
X 
X 
SPEP 
X  
X 
X 
UPEP-random  
X 
X 
X 
SIFE 
X 
X 
X 
UIFE -random 
X 
X 
X 
Serum FLC assay6.1 
X  
X 
X 
Bone marrow plasma cell percentage6.2 
X  
X 
X 
Bone marrow immunohistochemistry or 
immunofluorescence6.3 
 
X 
X 
Soft tissue plasmacytomas assessment6.4 
 
X 
X 
Disease & survival follow-up/post-therapies7 
 
  
 
 X  
X 
X 
X 
X 
X 
Immune cell levels & phenotype8, 11 
 
X8 
 
 
X8 
X8 
 
 
X8 
 
 
 
 
PKx, IL-2, IL-4, IL-6, IL-10, IFN-, TNF-9,11 
 
X9 
 
 
 
 
 
 
 
 
Immunogenicity tests10, 11 
 
X10 
 
 
 
X 
 
 
 
X 
Study drug (ALT-803)
 
a1 
a2 
a3 
a4 
a5 
a6 
a7 
a8 
 
Follow the same schedule 
as in the first 2 cycles of study 
treatment 
1Screening/baseline evaluations are performed < 14 days prior to start of therapy.  If the patient's condition is deteriorating, ECOG status and laboratory evaluations should be repeated within 48 hours prior to 
initiation of study treatment infusion.  2Pregnancy test is for women with childbearing potential only.  3Vital signs (especially blood pressure), clinical status and laboratory tests should be reviewed before start of 
therapy. Vital signs will be evaluated at 15, 30, 60 and 120 minutes and then hourly post infusion until discharge (or at completion of dose monitoring) from the clinic, and body weight before infusion on drug 
infusion day. 4Patients who have an on-going study drug-related SAE upon study completion or at discontinuation of study will be contacted by the investigator or his/her designee every week until the event is 
resolved or determined to be irreversible. 5If the screening EKG was performed within 14 days prior to start of study treatment, the EKG is not required. 6Disease response and progression assessment will be evaluated 
using the new International Uniform Response Criteria for Multiple Myeloma proposed by the International Myeloma Working Group. 6.1Only when serum and urine M-protein are unmeasurable. 6.2 Only when serum 
and urine M-protein and serum FLC are unmeasurable and bone marrow plasma cell percentage > 30% at baseline. 6.3Only when sCR is to be determined. 6.4Only when present at baseline, and to confirm CR or PR 
by X-rays, MRI or CT scans. 7Information about tumor assessment & other therapies received after completion of study treatment will be collected if available.  8Fresh blood samples for immune cell levels & 
phenotype testing will be collected before dosing. 9Collect blood samples at Time 0 (before drug infusion), at 30 min (+/- 5 min), 2 hour (+/- 15 min), 4 hour(+/- 30 min), 6 hour (+/- 60 min) , 24 hour (+/- 6 hour)- 
from Time 0.  IL-2, IL-4, IL-6, IL-10, IFN- and TNF- assays are performed using the same samples and at the same schedule as PK.  10Use the sample collected before dosing for PK test. 11Residual samples may 
be used by Sponsor for research studies of other biomarkers. xThe last PK sample will be collected on the next day. 

CLINICAL STUDY PROTOCOL 
Protocol Number: 
CA-ALT-803-02-13 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed 
or Refractory Multiple Myeloma 
Date of Protocol: 
Version# 01 
Version# 02 
January 7, 2014 
February 3, 2014 
Sponsor Contact: 
Hing C. Wong, Ph.D. 
Altor Bioscience Corporation. 
Miramar, Florida 33025 
Telephone: 
954-443-8600
Safety Data Fax: 
954-443-8602

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 3 of 65 
 
 
Table of Contents 
SYNOPSIS ................................................................................................................................................................6 
1. 
OBJECTIVES ................................................................................................................................................12 
1.1 
PRIMARY OBJECTIVES .............................................................................................................................12 
1.2 
SECONDARY OBJECTIVES ........................................................................................................................12 
2. 
BACKGROUND ............................................................................................................................................12 
2.1 
ALT-803 – GENERAL INFORMATION.......................................................................................................12 
2.2 
MULTIPLE MYELOMA .............................................................................................................................13 
2.3 
IMMUNE-BASED THERAPIES FOR CANCER ...............................................................................................13 
2.4 
PHARMACOLOGICAL EFFECTS OF ALT-803 IN VITRO AND IN ANIMALS ..................................................14 
 
Development of ALT-803 (IL-15N72D:IL-15RαSu/IgG1 Fc complex) .............................................................. 14 
2.4.1
 
In vitro biological activity of ALT-803 ............................................................................................................... 15 
2.4.2
 
In vivo biological activity of ALT-803 ............................................................................................................... 15 
2.4.3
 
Potent anti-tumor activity of ALT-803 in mouse models .................................................................................... 16 
2.4.4
 
Anti-myeloma mechanism of action of ALT-803 ................................................................................................ 17 
2.4.5
2.5 
NON-CLINICAL TOXICOLOGY ..................................................................................................................17 
 
Multi-dose toxicity studies in mice ..................................................................................................................... 17 
2.5.1
 
Multi-dose toxicity studies in cynomolgus monkeys ........................................................................................... 18 
2.5.2
2.6 
PHARMACOKINETICS ...............................................................................................................................19 
 
Non-clinical pharmacokinetics .......................................................................................................................... 19 
2.6.1
 
Clinical pharmacokinetics ................................................................................................................................. 20 
2.6.2
2.7 
RATIONALE FOR HUMAN CLINICAL STARTING DOSE ...............................................................................20 
2.8 
HUMAN EXPERIENCE ...............................................................................................................................20 
3. 
RATIONALE FOR THE CURRENT STUDY ...........................................................................................21 
4. 
OVERALL STUDY DESIGN .......................................................................................................................22 
5. 
STUDY POPULATION ................................................................................................................................24 
5.1 
INCLUSION CRITERIA ...............................................................................................................................24 
5.2 
EXCLUSION CRITERIA ..............................................................................................................................25 
5.3 
INCLUSION OF WOMEN AND MINORITIES .................................................................................................25 
6. 
STUDY DESIGN ...........................................................................................................................................26 
6.1 
STUDY FLOW DIAGRAM ...........................................................................................................................26 
6.2 
SCREENING AND ENROLLMENT ...............................................................................................................26 
6.3 
STUDY TREATMENT .................................................................................................................................26 
 
Treatment setting ............................................................................................................................................... 27 
6.3.1
 
Treatment regimen and study scheme ................................................................................................................ 27 
6.3.2
 
Study drug preparation ...................................................................................................................................... 27 
6.3.3
 
Study drug administration .................................................................................................................................. 27 
6.3.4
 
Pre and post-therapy intervention guidelines .................................................................................................... 28 
6.3.5
6.4 
DURATION OF PATIENT PARTICIPATION ..................................................................................................29 
6.5 
DOSE ESCALATION PHASE .......................................................................................................................29 
6.6 
EXPANSION PHASE ..................................................................................................................................30 
6.7 
STOPPING RULES .....................................................................................................................................31 
 
During dose escalation phase of the study ......................................................................................................... 31 
6.7.1
 
During expansion phase of the study ................................................................................................................. 31 
6.7.2
 
At any time during the study .............................................................................................................................. 31 
6.7.3
6.8 
PATIENT MONITORING, RESPONSE EVALUATION, DISEASE PROGRESSION & SURVIVAL FOLLOW-UP .....32 
 
Patient monitoring ............................................................................................................................................. 32 
6.8.1
 
Response evaluation ........................................................................................................................................... 32 
6.8.2
 
Disease progression and survival follow-up ...................................................................................................... 32 
6.8.3

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 4 of 65 
 
6.9 
DOSE LIMITING TOXICITY ........................................................................................................................32 
 
Definition of dose limiting toxicity ..................................................................................................................... 32 
6.9.1
 
Definition of maximum tolerated dose (MTD) ................................................................................................... 33 
6.9.2
 
Definition of minimal efficacious dose (MED) .................................................................................................. 33 
6.9.3
6.10 
STUDY TREATMENT DISCONTINUATION ..................................................................................................33 
 
Study treatment discontinuation events ......................................................................................................... 33 
6.10.1
 
Replacement of participants .......................................................................................................................... 33 
6.10.2
 
Follow-ups after treatment discontinuation .................................................................................................. 34 
6.10.3
6.10.3.1. 
Discontinuation due to SAEs or on-going study drug related AEs .......................................................... 34 
6.10.3.2. 
Discontinuation due to any other reasons ................................................................................................. 34 
6.11 
STUDY TREATMENT INTERRUPTION ........................................................................................................34 
 
Kidney dysfunction ........................................................................................................................................ 34 
6.11.1
 
Hematological dysfunction ............................................................................................................................ 34 
6.11.2
 
Hypotension .................................................................................................................................................. 34 
6.11.3
 
Allergic reactions and cytokine release syndrome/acute infusion reaction .................................................. 35 
6.11.4
6.12 
GENERAL SUPPORTIVE CARE GUIDELINES AND DRUG INTERACTION ......................................................35 
 
Hypotension and capillary leak syndrome .................................................................................................... 35 
6.12.1
 
Pulmonary dysfunction .................................................................................................................................. 36 
6.12.2
 
Impaired kidney and liver functions .............................................................................................................. 36 
6.12.3
 
Infection ........................................................................................................................................................ 36 
6.12.4
 
Fever and chills ............................................................................................................................................. 36 
6.12.5
 
Gastritis ......................................................................................................................................................... 36 
6.12.6
 
Diarrhea, nausea and vomiting ..................................................................................................................... 36 
6.12.7
 
Pruritus and dermatitis ................................................................................................................................. 36 
6.12.8
 
Acidosis ......................................................................................................................................................... 36 
6.12.9
 
Life-threatening toxicities ............................................................................................................................. 36 
6.12.10
 
Other supportive care ................................................................................................................................... 36 
6.12.11
 
Drug interaction ............................................................................................................................................ 36 
6.12.12
7. 
STUDY DRUG: AVAILABILITY, ACCOUNTABILITY, PACKAGING & LABELING ...................38 
7.1 
AVAILABILITY .........................................................................................................................................38 
7.2 
ACCOUNTABILITY ...................................................................................................................................38 
7.3 
PACKAGING .............................................................................................................................................38 
7.4 
LABELING ................................................................................................................................................38 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS ................................................................39 
8.1 
STUDY CALENDAR ...................................................................................................................................39 
8.2 
PROCEDURE AND TESTS ..........................................................................................................................40 
 
Assays for immune cell levels and phenotype .................................................................................................... 40 
8.2.1
 
Medical history & prior therapy ........................................................................................................................ 40 
8.2.2
 
Pregnancy test .................................................................................................................................................... 40 
8.2.3
 
Physical examination ......................................................................................................................................... 40 
8.2.4
 
Vital signs, body weight & height ...................................................................................................................... 40 
8.2.5
 
Cardiac assessment ............................................................................................................................................ 40 
8.2.6
 
Pulmonary function monitoring ......................................................................................................................... 40 
8.2.7
 
Clinical blood tests ............................................................................................................................................ 41 
8.2.8
 
Disease assessment tests and procedures .......................................................................................................... 41 
8.2.9
 
Adverse event assessment .............................................................................................................................. 41 
8.2.10
 
Response assessment ..................................................................................................................................... 41 
8.2.11
 
Disease progression and survival follow-up ................................................................................................. 41 
8.2.12
 
Pharmacokinetic (PK) testing ....................................................................................................................... 42 
8.2.13
 
Biomarker assays for IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α .................................................................. 42 
8.2.14
 
Immunogenicity tests - detection of anti-ALT-803 antibodies ....................................................................... 42 
8.2.15
9. 
MEASUREMENT OF EFFECT ..................................................................................................................43 
9.1 
MEASURABLE DISEASE ............................................................................................................................43 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 5 of 65 
 
9.2 
EFFECT ASSESSMENT SCHEDULE .............................................................................................................43 
9.3 
METHODOLOGY OF RESPONSE EVALUATION ..........................................................................................43 
9.4 
RESPONSE EVALUATION CRITERIA ..........................................................................................................44 
9.5 
DISEASE PROGRESSION EVALUATION CRITERIA ......................................................................................45 
10. 
STATISTICAL ANALYSIS .....................................................................................................................46 
10.1 
STUDY OBJECTIVES .................................................................................................................................46 
10.2 
SAMPLE SIZE ............................................................................................................................................46 
10.3 
DATA COLLECTION ..................................................................................................................................46 
10.4 
DATA ANALYSIS ......................................................................................................................................46 
 
Analysis of safety ........................................................................................................................................... 47 
10.4.1
 
Analysis of response ...................................................................................................................................... 47 
10.4.2
 
Pharmacokinetics .......................................................................................................................................... 47 
10.4.3
11. 
REGULATORY AND REPORTING REQUIREMENTS ....................................................................48 
11.1 
ADVERSE EVENTS RECORDING, REPORTING AND COMMUNICATION .......................................................48 
11.2 
ADVERSE EVENT TERMINOLOGY AND DEFINITIONS ................................................................................48 
11.3 
ADVERSE EVENT REPORTING PROCEDURES ...........................................................................................49 
11.4 
ADVERSE EVENT EXPEDITED REPORTING GUIDELINES ..........................................................................50 
11.5 
SUBMISSION OF SERIOUS ADVERSE EVENT REPORTING ...........................................................................50 
11.6 
DATA REPORTING FORMS .......................................................................................................................50 
11.7 
REPORT /DATA SUBMISSION ADDRESS & CONTACT ................................................................................51 
11.8 
PATIENT RECORDS, QUALITY ASSURANCE, RECORDS RETENTION ..........................................................51 
11.9 
METHOD OF REVIEW ...............................................................................................................................51 
11.10 
SPECIAL REGULATORY CONSIDERATIONS ...........................................................................................52 
 
HIPAA ........................................................................................................................................................... 52 
11.10.1
 
Protocol amendments, informed consent, and IRB approval ........................................................................ 52 
11.10.2
12. 
CONFIDENTIALITY ...............................................................................................................................52 
13. 
ETHICAL STANDARDS & INVESTIGATOR OBLIGATIONS .......................................................52 
14. 
LIST OF EXPECTED ADVERSE EVENTS ..........................................................................................53 
15. 
CTCAE .......................................................................................................................................................55 
REFERENCES .......................................................................................................................................................56 
APPENDIX A: ECOG ...........................................................................................................................................58 
APPENDIX B: NEW YORK HEART ASSOCIATION CLASSIFICATION .................................................58 
APPENDIX C: ETHICAL STANDARDS ...........................................................................................................59 
APPENDIX D: INVESTIGATOR OBLIGATIONS ...........................................................................................60 
APPENDIX E: CONTACT LIST - ALTOR ........................................................................................................64 
APPENDIX F: CONTACT LIST – DATA SAFETY MONITORING BOARD (DSMB) ...............................65 
APPENDIX G: CONTACT LIST - LABORATORIES......................................................................................65 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 6 of 65 
SYNOPSIS 
Sponsor: 
Altor Bioscience Corporation 
Protocol#: 
CA-ALT-803-02-13 
Study Drug Name: Not applicable 
Study Treatment 
Active agents: 
ALT-803, a “recombinant human super agonist interleukin-15 (IL-15) complex” 
(AKA, IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
Study Type: 
Interventional 
Study Phase: 
Ib/II 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed or Refractory Multiple Myeloma 
Objectives: 
To evaluate the safety and tolerability of escalating doses, identify the Maximum 
Tolerated Dose level (MTD) or Minimum Efficacious Dose (MED) and designate 
a dose level for Phase II study (RP2D) of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
 
To evaluate the effect of ALT-803 on the peripheral absolute lymphocyte counts 
(ALC) and white blood cell (WBC) counts, the number and phenotype of 
peripheral blood T (total and subsets) and NK cells. 
To estimate the anti-tumor activity of ALT-803 by radiologic or pathologic disease 
response, progression free survival, and overall survival in treated patients.  
To characterize the immunogenicity and pharmacokinetic profile, including serum 
levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-803 in treated 
patients. 
 
Study Design: 
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-
escalation study of ALT-803 in patients with relapsed or refractory multiple 
myeloma. 
 
The study includes a dose escalation phase to determine the MTD or MED using a 
modified classic (3+3) dose escalation design and to designate a dose level for the 
Phase II expansion phase (RP2D) and a two-stage expansion phase at the RP2D 
using a Simon two-stage design. In Phase I, five dose levels will be evaluated. A 
step-down dose level (cohort# -1) will be provided in the event of encountering 
DLT in two patients at the planned initial dose level. In the absence of 
unacceptable toxicity or disease progression, each enrolled patient will receive up 
to four 6-week study treatment cycles, each consisting of a 4-week treatment 
period and a 2-week rest period. In each cycle, patients will receive four doses of 
ALT-803 by intravenous injection weekly for 4 weeks followed by a 2-week rest 
period. Patients with sufficient recovery of toxicities from the previous treatment 
cycles will be eligible to continue study treatment. After receiving two treatment 
cycles, patients who have at least stable disease assessed at week 11-12 may 
receive up to two additional study treatment cycles followed by reassessment for 
continued tumor response. 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 7 of 65 
The study will be conducted in conformity with Good Clinical Practice (GCP).  
 
Treatments:  
The study treatment plan for each enrolled patient includes up to four 6-week study 
treatment cycles. In each cycle, patients will receive four weekly doses of ALT-803 
by intravenous injection followed by a 20-day rest period. The rest period may be 
extended to include up to four additional weeks if necessary. Patients who do not 
experience or who sufficiently recover from toxicities of the previous treatment 
cycles will be eligible to continue the treatment included in the study treatment 
plan. 
Treated patients will have up to two anti-tumor evaluation visits. Patients who 
receive at least three study drug doses during the first 2-cycle treatment period will 
be evaluated for anti-tumor response during week 11-12. Patients who have at least 
stable disease from the first anti-tumor evaluation and who meet other criteria to 
continue study treatment will receive up to two additional study treatment cycles, 
with the same treatment schedule and at the same dose level as the first two cycles, 
followed by reassessment for continued tumor response. 
The study treatment and response evaluation schedule is illustrated below: 
Treatment Cycle 
Cycle #1 
REST 
Cycle #2 
Response 
Evaluation 
Cycle #3 
REST 
Cycle #4 
Response 
Evaluation 
Treatment Week 
1 
2 
3 
4 
5-6 
7 
8 
9 10 
11-12 
13 14 15 16 
17-18 
19 
20 21 22 
23-24 
Treatment Day 
1 
8 
15 22 
23-42 
43 50 57 64 
65-84 
85 92 99 106 107-126 127 134 141 148 149-168 
Dose# 
1 
2 
3 
4 
Rest 
weeks 
5 
6 
7 
8 
 
9 10 11 12 
Rest 
weeks 
13 
14 15 16 
 
Response Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
ALT-803 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
There are no restrictions on further therapies, such as chemotherapy, radiation 
therapy or surgery to be used after the protocol-specified therapy. Clearly, post-
study treatments could be of significant clinical benefit in selected patients, and 
these patients will be followed for outcome. 
Enrolled patients will receive the study treatment at qualified cancer treatment 
centers with adequate diagnostic and treatment facilities to provide appropriate 
management of therapy and complications. ALT-803 will be administered by 
intravenous infusion into a central or peripheral vein under the supervision of a 
qualified physician experienced in the use of biologic anti-cancer agents. 
Dose Escalation 
Phase: 
A modified 3 + 3 design will be used for identifying a tolerable dose for phase II 
studies by monitoring patients for DLTs to determine the MTD and for identifying 
an efficacious dose by monitoring patients’ ALC and WBC count to determine the 
MED during the DLT observation period. The dose escalation phase is concluded 
when either the MTD or the MED is determined. A dose level (RP2D) will then be 
designated for Phase II study. There are five escalating dose levels of ALT-803 
and a step-down cohort (-1) with a lower dose level of ALT-803 in the event that 
unexpected toxicity is encountered at the initial dose level. 
 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 8 of 65 
 
Below are the planned dose levels of the study drug during the dose escalation 
phase of the study.  
 
 
 
 
 
 
  
 
Dose limiting toxicity (DLT) is defined as follows: any toxicity that is not clearly 
unrelated to drug administration that is of Grade 3 and does not resolve to Grade 1 
or lower within a week despite the use of medical intervention or that is of Grade 
4, with exceptions described in the study protocol.  
The DLT Observation Period is defined as the duration of the first treatment cycle. 
 
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out 
of 6 patients experienced DLT and that is one level below a dose that was not 
tolerated. 
 
Minimal Efficacious Dose (MED) is defined as a dose level which produces an 
ALC ≥25,000/µL sustained for 14 days or a total WBC ≥35,000/µL sustained for 
14 days among 2/3 or 4/6 of patients. For safety, we have also defined an 
“exceeding MED” as the occurrence of ALC ≥35,000/µL or WBC ≥50,000/µL 
sustained for 14 days. 
 
Expansion 
Phase 
The two-stage expansion phase at the MTD or the MED level will be conducted 
using an optimal Simon’s two-stage design. Objective response (OR) (defined as 
complete response (CR) + partial response (PR)) will be evaluated and set 
thresholds of lack of efficacy (OR rate (ORR) = 10%) and an efficacy level of 
interest (ORR = 30%) will be selected.  
Stopping Rules: 
Patient enrollment will be temporarily suspended based on occurrence of any of 
the following events, and the study committee, including the sponsor, the Data 
Safety Monitoring Board and principal investigators will meet to discuss how to 
proceed with future patient enrollment in the study. 
During the dose escalation phase of the study,  
• If the maximum planned dose level has been reached, but neither the MTD nor 
MED can be determined. 
Cohort 
ALT-803 Dose (µg/kg) 
Number of patients 
-1 
0.5 
3 to 6 
1 (initial) 
1 
3 to 6 
2 
3 
3 to 6 
3 
6 
3 to 6 
4 
10 
3 to 6 
5 
20 
3 to 6 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 9 of 65 
• If de-escalation occurs and the step-down dose level cannot be designated as 
the MTD or MED.  
Any time during the expansion phase of the study,  
• More than 33% of patients experience a possible, probable or definite study 
drug related DLT. 
• Favorable anti-tumor response data collected from enrolled patients. 
At any time during the study, 
The study committee may meet to discuss how to proceed with the study and may 
make any or all of the following recommendations for further patient enrollment:  
• Downward adjust the study drug dose. 
• Adjust the study drug dosing schedule. 
• Recommend more effective pre-therapy, intra-therapy and post-therapy side 
effect mitigation interventions. 
• Correct protocol technical errors that caused unnecessary dose omissions or 
premature treatment discontinuations. After correction of protocol errors, the 
DSMB may meet to re-evaluate the safety profile of the study treatment and 
recommend how to proceed with the study, if necessary. 
Evaluations: 
Patients will be evaluated for clinical toxicities during the treatment. Patients’ 
blood samples will be collected to assess the pharmacokinetic profile and 
immunogenicity of the study drug. The anti-tumor response will be evaluated at 
week 11-12 and week 23-24 from the start of study treatment. All patients who 
receive at least 3 doses of the study drug ALT-803 will be included in the anti-
tumor response evaluation. 
Population: 
Patients of 18 years of age and above with relapsed or refractory multiple 
myeloma. Patients also need to have adequate cardiac, pulmonary, liver and 
kidney functions and have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0, 1 or 2.  
Sample Size: 
A total of up to 30 assessable patients will be accrued to the dose escalation phase of 
the study (Phase Ib). Anticipated enrollment to this phase is 18 patients. Up to an 
additional 23 assessable patients will be enrolled at the expansion phase (Stage 1 
and 2) of the study (Phase II). A total of approximately 41 assessable patients will 
be enrolled to complete the study. Assuming a 20% rate of ineligible or non-
assessable cases, a total of up to 50 patients may be accrued to the study. 
 
Primary 
Endpoints 
For Phase Ib only 
(1) Determination of the MTD or MED and designation of the recommended dose 
level (RP2D) for Phase II study of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
For Phase Ib & II 
(2) Safety profile of ALT-803 in treated patients. 
 
(3) Disease response rate of treated patients.  
Secondary  

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 10 of 65 
Endpoints 
(1) Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, 
the number and phenotype of peripheral blood T (total and subsets) and NK 
cells in treated patients. 
 
(2) Duration of response in treated patients. 
 
(3) Progression free survival of treated patients. 
(4) Overall survival of treated patients. 
(5) Characterization of the immunogenicity and pharmacokinetic profile, 
including serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-
803 in treated patients. 
Pharmacokinetics 
& Biomarkers: 
Fresh blood samples will be collected to assess immune cell levels and phenotype, 
and serum samples for pharmacokinetics, immunogenicity of the study drug ALT-
803, and the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α after ALT-
803 administration in treated patients. Blood samples for pharmacokinetic analysis 
will be taken on the first day of ALT-803 administration in the first study 
treatment cycle. Venous blood will be obtained at Time 0 (before the start of 
infusion), at 30 minutes, and 2, 4, 6 and 24 hours from Time 0 for the assessment 
of ALT-803 serum concentrations. Non-compartmental and compartmental 
analyses will be conducted. In addition, the same blood samples collected for PK 
analysis will be used to assess the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ 
and TNF-α. Fresh blood samples for immune cell levels and phenotype testing 
will be collected before the start of first and fourth dose of study drug infusion in 
each treatment cycle. Bone marrow samples will be collected for future analysis of 
molecular markers associated with responses or resistance to ALT-803 in patients 
with relapsed or refractory multiple myeloma. 
Monitoring Tests: Blood samples for standard chemistry and CBC with differential will be obtained 
at screening, on each study drug infusion day, and at follow-up visits. Blood 
samples for immunogenicity testing for anti-ALT-803 antibodies will be collected 
prior to dosing on the first ALT-803 infusion day and at weeks 7 and 12 from the 
initial dose of study treatment. Blood and urine samples will be collected on each 
follow-up visit for response assessment.  
Response 
Assessment: 
There are at least two response assessments for treated patients: the first 
assessment during week 11-12 and the second assessment during week 23-24 from 
the start of study treatment. After completion of the first two cycles of study 
treatment, patients who have received at least 3 doses of study drug will have the 
first response assessment. After completion of the two additional cycles of study 
treatment, patients, regardless of the number of additional study drug doses 
received, will have the second response assessment. Response assessments will be 
carried out according to the new International Uniform Response Criteria for 
Multiple Myeloma proposed by the International Myeloma Working Group. 
Baseline evaluations should be performed up to 14 days before study treatment 
starts.  
Progression & 
Survival 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 02 
IND 114006 SERIAL# 0001 
 
               
 
 
 
                             February 3, 2014 
Page 11 of 65 
Assessment: 
Progression-free survival, overall survival, and duration of response of all treated 
patients will be assessed every three months during year 1 and then every 6 
months during years 2 and 3 from the start of study treatment, or through the point 
designated as the end of the study follow up. 
Adverse Events: 
All patients will be monitored and evaluated for clinical toxicities during the 
treatment period and queried at each follow-up visit for Adverse Events (AEs). 
Patients may volunteer information concerning AEs. All adverse events will be 
graded by using the NCI Common Terminology Criteria for Adverse Events 
version 4.0 (CTCAE v4.0), and logged in the patient Case Report Form. The study 
centers should report all Serious Adverse Events (SAEs) and all events that trigger 
patient’s study treatment discontinuation to the sponsor via phone, fax or email (or 
a combination) no more than 24 hours after learning of the event. The sponsor will 
use the information to manage and coordinate the dose escalation, cohort 
expansion and patient enrollment. The sponsor will then inform all of the 
participating clinical sites of the current dose level and the number of patients to 
be enrolled at that level, or of any patient enrollment suspension via phone, fax or 
email within 24 hours of learning of the event. The study centers should report all 
other adverse events to the sponsor following the guidelines defined in the study 
protocol. All study drug related AEs that are both serious and unexpected will be 
reported to the FDA in an expedited manner in accordance with 21 CFR §312.32. 
Statistical Plan: 
For each cohort, all AEs will be tabulated and examined and all safety, 
pharmacokinetic and tumor response data will be evaluated. For estimation of 
duration of response and progression free survival, the Kaplan-Meier method will 
be used. P-values of ≤0.05 (two-sided) will be considered to indicate statistical 
significance.  
 
 

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 02 
IND 114006 SERIAL# 0001 
 
          
 
 
 
 
 
              
 
 
 
                 February 3, 2014 
Page 39 of 65 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS 
8.1 
Study calendar 
TESTS & PROCEDURES 
SCREEN/ 
BASELINE1 
TREATMENT 
CYCLE #1 
REST  
TREATMENT 
CYCLE  #2 
1ST RESPONSE 
ASSESSMENT   
TREATMENT CYCLES     
#3 AND #4  
2ND RESPONSE 
ASSESSMENT 
FOLLOW-UPS 
Study Month  
 
1 
 
2 
3 
4-5 
6 
9  
12  
18  
24   30  36   
Study Week  
 
1 
2     3 
4 
5-6 
7  
8 
9 
10 
11-12 
13-22 
23-24 
Any day during the month  
Study Day  
 
1  
8  
15  
22  
23-42 
 43 
50  
57  
 64 
65-84  
85-148 
149-168 
Tolerance Window 
 
+/- 2 days 
23-42 
+/- 2 days 
Any day 
 
Any day 
Medical history 
X 
 
 
 
 
R 
 
E 
 
S 
 
T 
 
 
P 
 
E 
 
R 
 
I 
 
O 
 
R 
 
 
 
 
 
Follow Institution’s 
standard of care (SOC) 
policy.  
If performed, follow the 
same schedule as in the 
first two cycles of study 
treatment. 
 
 
 
Serum pregnancy test2 
X 
 
 
 
 
 
 
 
 
 
 
Complete physical exam 
X 
X 
 
 
 
X 
 
 
 
X 
X 
Vital signs, Weight, Height3, Cardiac & Lung 
function monitoring  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concurrent medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event assessment4 
X 
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC with Differential 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Blood Chemistry  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
EKG 
X 
X5 
 
X 
 
 
 
 
 
PFT only when clinically indicated 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Response evaluation6 
  
  
 
X 
  
X 
 
Serum quantitative immunoglobulins 
X 
X 
X 
SPEP 
X  
X 
X 
UPEP-random  
X 
X 
X 
SIFE 
X 
X 
X 
UIFE -random 
X 
X 
X 
Serum FLC assay6.1 
X  
X 
X 
Bone marrow plasma cell percentage6.2 
X  
X 
X 
Bone marrow immunohistochemistry or 
immunofluorescence6.3 
 
X 
X 
Soft tissue plasmacytomas assessment6.4 
 
X 
X 
Disease & survival follow-up/post-therapies7 
 
  
 
 X  
X 
X 
X 
X 
X 
Immune cell levels & phenotype8, 11 
 
X8 
 
 
X8 
X8 
 
 
X8 
 
 
 
 
PKx, IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α9,11 
 
X9 
 
 
 
 
 
 
 
 
Immunogenicity tests10, 11 
 
X10 
 
 
 
X 
 
 
 
X 
Study drug (ALT-803)
 
a1 
a2 
a3 
a4 
a5 
a6 
a7 
a8 
 
Follow the same schedule 
as in the first 2 cycles of study 
treatment 
1Screening/baseline evaluations are performed < 14 days prior to start of therapy.  If the patient's condition is deteriorating, ECOG status and laboratory evaluations should be repeated within 48 hours prior to 
initiation of study treatment infusion.  2Pregnancy test is for women with childbearing potential only.  3Vital signs (especially blood pressure), clinical status and laboratory tests should be reviewed before start of 
therapy. Vital signs will be evaluated at 15, 30, 60 and 120 minutes and then hourly post infusion until discharge (or at completion of dose monitoring) from the clinic, and body weight before infusion on drug 
infusion day. 4Patients who have an on-going study drug-related SAE upon study completion or at discontinuation of study will be contacted by the investigator or his/her designee every week until the event is 
resolved or determined to be irreversible. 5If the screening EKG was performed within 14 days prior to start of study treatment, the EKG is not required. 6Disease response and progression assessment will be evaluated 
using the new International Uniform Response Criteria for Multiple Myeloma proposed by the International Myeloma Working Group. 6.1Only when serum and urine M-protein are unmeasurable. 6.2 Only when serum 
and urine M-protein and serum FLC are unmeasurable and bone marrow plasma cell percentage > 30% at baseline. 6.3Only when sCR is to be determined. 6.4Only when present at baseline, and to confirm CR or PR 
by X-rays, MRI or CT scans. 7Information about tumor assessment & other therapies received after completion of study treatment will be collected if available.  8Fresh blood samples for immune cell levels & 
phenotype testing will be collected before dosing. 9Collect blood samples at Time 0 (before drug infusion), at 30 min (+/- 5 min), 2 hour (+/- 15 min), 4 hour(+/- 30 min), 6 hour (+/- 60 min) , 24 hour (+/- 6 hour)- 
from Time 0.  IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α assays are performed using the same samples and at the same schedule as PK.  10Use the sample collected before dosing for PK test. 11Residual samples may 
be used by Sponsor for research studies of other biomarkers. xThe last PK sample will be collected on the next day. 

CLINICAL STUDY PROTOCOL 
Protocol Number: 
CA-ALT-803-02-13 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed 
or Refractory Multiple Myeloma 
Date of Protocol: 
Version# 01 
Version# 02 
Version# 03 
January 7, 2014 
February 3, 2014 
February 5, 2014 
Sponsor Contact: 
Hing C. Wong, Ph.D. 
Altor Bioscience Corporation. 
Miramar, Florida 33025 
Telephone: 
954-443-8600
Safety Data Fax: 
954-443-8602

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 3 of 66 
 
 
Table of Contents 
SYNOPSIS ................................................................................................................................................................6 
1. 
OBJECTIVES ................................................................................................................................................12 
1.1 
PRIMARY OBJECTIVES .............................................................................................................................12 
1.2 
SECONDARY OBJECTIVES ........................................................................................................................12 
2. 
BACKGROUND ............................................................................................................................................12 
2.1 
ALT-803 – GENERAL INFORMATION.......................................................................................................12 
2.2 
MULTIPLE MYELOMA .............................................................................................................................13 
2.3 
IMMUNE-BASED THERAPIES FOR CANCER ...............................................................................................13 
2.4 
PHARMACOLOGICAL EFFECTS OF ALT-803 IN VITRO AND IN ANIMALS ..................................................14 
 
Development of ALT-803 (IL-15N72D:IL-15RαSu/IgG1 Fc complex) .............................................................. 14 
2.4.1
 
In vitro biological activity of ALT-803 ............................................................................................................... 15 
2.4.2
 
In vivo biological activity of ALT-803 ............................................................................................................... 15 
2.4.3
 
Potent anti-tumor activity of ALT-803 in mouse models .................................................................................... 16 
2.4.4
 
Anti-myeloma mechanism of action of ALT-803 ................................................................................................ 17 
2.4.5
2.5 
NON-CLINICAL TOXICOLOGY ..................................................................................................................17 
 
Multi-dose toxicity studies in mice ..................................................................................................................... 17 
2.5.1
 
Multi-dose toxicity studies in cynomolgus monkeys ........................................................................................... 18 
2.5.2
2.6 
PHARMACOKINETICS ...............................................................................................................................19 
 
Non-clinical pharmacokinetics .......................................................................................................................... 19 
2.6.1
 
Clinical pharmacokinetics ................................................................................................................................. 20 
2.6.2
2.7 
RATIONALE FOR HUMAN CLINICAL STARTING DOSE ...............................................................................20 
2.8 
HUMAN EXPERIENCE ...............................................................................................................................20 
3. 
RATIONALE FOR THE CURRENT STUDY ...........................................................................................21 
4. 
OVERALL STUDY DESIGN .......................................................................................................................22 
5. 
STUDY POPULATION ................................................................................................................................24 
5.1 
INCLUSION CRITERIA ...............................................................................................................................24 
5.2 
EXCLUSION CRITERIA ..............................................................................................................................25 
5.3 
INCLUSION OF WOMEN AND MINORITIES .................................................................................................25 
6. 
STUDY DESIGN ...........................................................................................................................................26 
6.1 
STUDY FLOW DIAGRAM ...........................................................................................................................26 
6.2 
SCREENING AND ENROLLMENT ...............................................................................................................26 
6.3 
STUDY TREATMENT .................................................................................................................................26 
 
Treatment setting ............................................................................................................................................... 27 
6.3.1
 
Treatment regimen and study scheme ................................................................................................................ 27 
6.3.2
 
Study drug preparation ...................................................................................................................................... 27 
6.3.3
 
Study drug administration .................................................................................................................................. 27 
6.3.4
 
Pre and post-therapy intervention guidelines .................................................................................................... 28 
6.3.5
6.4 
DURATION OF PATIENT PARTICIPATION ..................................................................................................29 
6.5 
DOSE ESCALATION PHASE .......................................................................................................................29 
6.6 
EXPANSION PHASE ..................................................................................................................................30 
6.7 
STOPPING RULES .....................................................................................................................................31 
 
During dose escalation phase of the study ......................................................................................................... 31 
6.7.1
 
During expansion phase of the study ................................................................................................................. 31 
6.7.2
 
At any time during the study .............................................................................................................................. 31 
6.7.3
6.8 
PATIENT MONITORING, RESPONSE EVALUATION, DISEASE PROGRESSION & SURVIVAL FOLLOW-UP .....32 
 
Patient monitoring ............................................................................................................................................. 32 
6.8.1
 
Response evaluation ........................................................................................................................................... 32 
6.8.2
 
Disease progression and survival follow-up ...................................................................................................... 32 
6.8.3

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 4 of 66 
 
6.9 
DOSE LIMITING TOXICITY ........................................................................................................................32 
 
Definition of dose limiting toxicity ..................................................................................................................... 32 
6.9.1
 
Definition of maximum tolerated dose (MTD) ................................................................................................... 33 
6.9.2
 
Definition of minimal efficacious dose (MED) .................................................................................................. 33 
6.9.3
6.10 
STUDY TREATMENT DISCONTINUATION ..................................................................................................33 
 
Study treatment discontinuation events ......................................................................................................... 33 
6.10.1
 
Replacement of participants .......................................................................................................................... 33 
6.10.2
 
Follow-ups after treatment discontinuation .................................................................................................. 35 
6.10.3
6.10.3.1. 
Discontinuation due to SAEs or on-going study drug related AEs .......................................................... 35 
6.10.3.2. 
Discontinuation due to any other reasons ................................................................................................. 35 
6.11 
STUDY TREATMENT INTERRUPTION ........................................................................................................35 
 
Kidney dysfunction ........................................................................................................................................ 35 
6.11.1
 
Hematological dysfunction ............................................................................................................................ 35 
6.11.2
 
Hypotension .................................................................................................................................................. 35 
6.11.3
 
Allergic reactions and cytokine release syndrome/acute infusion reaction .................................................. 36 
6.11.4
6.12 
GENERAL SUPPORTIVE CARE GUIDELINES AND DRUG INTERACTION ......................................................36 
 
Hypotension and capillary leak syndrome .................................................................................................... 36 
6.12.1
 
Pulmonary dysfunction .................................................................................................................................. 37 
6.12.2
 
Impaired kidney and liver functions .............................................................................................................. 37 
6.12.3
 
Infection ........................................................................................................................................................ 37 
6.12.4
 
Fever and chills ............................................................................................................................................. 37 
6.12.5
 
Gastritis ......................................................................................................................................................... 37 
6.12.6
 
Diarrhea, nausea and vomiting ..................................................................................................................... 37 
6.12.7
 
Pruritus and dermatitis ................................................................................................................................. 37 
6.12.8
 
Acidosis ......................................................................................................................................................... 37 
6.12.9
 
Life-threatening toxicities ............................................................................................................................. 37 
6.12.10
 
Other supportive care ................................................................................................................................... 37 
6.12.11
 
Drug interaction ............................................................................................................................................ 37 
6.12.12
7. 
STUDY DRUG: AVAILABILITY, ACCOUNTABILITY, PACKAGING & LABELING ...................39 
7.1 
AVAILABILITY .........................................................................................................................................39 
7.2 
ACCOUNTABILITY ...................................................................................................................................39 
7.3 
PACKAGING .............................................................................................................................................39 
7.4 
LABELING ................................................................................................................................................39 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS ................................................................40 
8.1 
STUDY CALENDAR ...................................................................................................................................40 
8.2 
PROCEDURE AND TESTS ..........................................................................................................................41 
 
Assays for immune cell levels and phenotype .................................................................................................... 41 
8.2.1
 
Medical history & prior therapy ........................................................................................................................ 41 
8.2.2
 
Pregnancy test .................................................................................................................................................... 41 
8.2.3
 
Physical examination ......................................................................................................................................... 41 
8.2.4
 
Vital signs, body weight & height ...................................................................................................................... 41 
8.2.5
 
Cardiac assessment ............................................................................................................................................ 41 
8.2.6
 
Pulmonary function monitoring ......................................................................................................................... 42 
8.2.7
 
Clinical blood tests ............................................................................................................................................ 42 
8.2.8
 
Disease assessment tests and procedures .......................................................................................................... 42 
8.2.9
 
Adverse event assessment .............................................................................................................................. 42 
8.2.10
 
Response assessment ..................................................................................................................................... 42 
8.2.11
 
Disease progression and survival follow-up ................................................................................................. 43 
8.2.12
 
Pharmacokinetic (PK) testing ....................................................................................................................... 43 
8.2.13
 
Biomarker assays for IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α .................................................................. 43 
8.2.14
 
Immunogenicity tests - detection of anti-ALT-803 antibodies ....................................................................... 43 
8.2.15
9. 
MEASUREMENT OF EFFECT ..................................................................................................................44 
9.1 
MEASURABLE DISEASE ............................................................................................................................44 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 5 of 66 
 
9.2 
EFFECT ASSESSMENT SCHEDULE .............................................................................................................44 
9.3 
METHODOLOGY OF RESPONSE EVALUATION ..........................................................................................44 
9.4 
RESPONSE EVALUATION CRITERIA ..........................................................................................................45 
9.5 
DISEASE PROGRESSION EVALUATION CRITERIA ......................................................................................46 
10. 
STATISTICAL ANALYSIS .....................................................................................................................47 
10.1 
STUDY OBJECTIVES .................................................................................................................................47 
10.2 
SAMPLE SIZE ............................................................................................................................................47 
10.3 
DATA COLLECTION ..................................................................................................................................47 
10.4 
DATA ANALYSIS ......................................................................................................................................47 
 
Analysis of safety ........................................................................................................................................... 48 
10.4.1
 
Analysis of response ...................................................................................................................................... 48 
10.4.2
 
Pharmacokinetics .......................................................................................................................................... 48 
10.4.3
11. 
REGULATORY AND REPORTING REQUIREMENTS ....................................................................49 
11.1 
ADVERSE EVENTS RECORDING, REPORTING AND COMMUNICATION .......................................................49 
11.2 
ADVERSE EVENT TERMINOLOGY AND DEFINITIONS ................................................................................49 
11.3 
ADVERSE EVENT REPORTING PROCEDURES ...........................................................................................50 
11.4 
ADVERSE EVENT EXPEDITED REPORTING GUIDELINES ..........................................................................51 
11.5 
SUBMISSION OF SERIOUS ADVERSE EVENT REPORTING ...........................................................................51 
11.6 
DATA REPORTING FORMS .......................................................................................................................51 
11.7 
REPORT /DATA SUBMISSION ADDRESS & CONTACT ................................................................................52 
11.8 
PATIENT RECORDS, QUALITY ASSURANCE, RECORDS RETENTION ..........................................................52 
11.9 
METHOD OF REVIEW ...............................................................................................................................52 
11.10 
SPECIAL REGULATORY CONSIDERATIONS ...........................................................................................53 
 
HIPAA ........................................................................................................................................................... 53 
11.10.1
 
Protocol amendments, informed consent, and IRB approval ........................................................................ 53 
11.10.2
12. 
CONFIDENTIALITY ...............................................................................................................................53 
13. 
ETHICAL STANDARDS & INVESTIGATOR OBLIGATIONS .......................................................53 
14. 
LIST OF EXPECTED ADVERSE EVENTS ..........................................................................................54 
15. 
CTCAE .......................................................................................................................................................56 
REFERENCES .......................................................................................................................................................57 
APPENDIX A: ECOG ...........................................................................................................................................59 
APPENDIX B: NEW YORK HEART ASSOCIATION CLASSIFICATION .................................................59 
APPENDIX C: ETHICAL STANDARDS ...........................................................................................................60 
APPENDIX D: INVESTIGATOR OBLIGATIONS ...........................................................................................61 
APPENDIX E: CONTACT LIST - ALTOR ........................................................................................................65 
APPENDIX F: CONTACT LIST – DATA SAFETY MONITORING BOARD (DSMB) ...............................66 
APPENDIX G: CONTACT LIST - LABORATORIES......................................................................................66 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 6 of 66 
SYNOPSIS 
Sponsor: 
Altor Bioscience Corporation 
Protocol#: 
CA-ALT-803-02-13 
Study Drug Name: Not applicable 
Study Treatment 
Active agents: 
ALT-803, a “recombinant human super agonist interleukin-15 (IL-15) complex” 
(AKA, IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
Study Type: 
Interventional 
Study Phase: 
Ib/II 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed or Refractory Multiple Myeloma 
Objectives: 
To evaluate the safety and tolerability of escalating doses, identify the Maximum 
Tolerated Dose level (MTD) or Minimum Efficacious Dose (MED) and designate 
a dose level for Phase II study (RP2D) of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
 
To evaluate the effect of ALT-803 on the peripheral absolute lymphocyte counts 
(ALC) and white blood cell (WBC) counts, the number and phenotype of 
peripheral blood T (total and subsets) and NK cells. 
To estimate the anti-tumor activity of ALT-803 by radiologic or pathologic disease 
response, progression free survival, and overall survival in treated patients.  
To characterize the immunogenicity and pharmacokinetic profile, including serum 
levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-803 in treated 
patients. 
 
Study Design: 
This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose-
escalation study of ALT-803 in patients with relapsed or refractory multiple 
myeloma. 
 
The study includes a dose escalation phase to determine the MTD or MED using a 
modified classic (3+3) dose escalation design and to designate a dose level for the 
Phase II expansion phase (RP2D) and a two-stage expansion phase at the RP2D 
using a Simon two-stage design. In Phase I, five dose levels will be evaluated. A 
step-down dose level (cohort# -1) will be provided in the event of encountering 
DLT in two patients at the planned initial dose level. In the absence of 
unacceptable toxicity or disease progression, each enrolled patient will receive up 
to four 6-week study treatment cycles, each consisting of a 4-week treatment 
period and a 2-week rest period. In each cycle, patients will receive four doses of 
ALT-803 by intravenous injection weekly for 4 weeks followed by a 2-week rest 
period. Patients with sufficient recovery of toxicities from the previous treatment 
cycles will be eligible to continue study treatment. After receiving two treatment 
cycles, patients who have at least stable disease assessed at week 11-12 may 
receive up to two additional study treatment cycles followed by reassessment for 
continued tumor response. 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 7 of 66 
The study will be conducted in conformity with Good Clinical Practice (GCP).  
 
Treatments:  
The study treatment plan for each enrolled patient includes up to four 6-week study 
treatment cycles. In each cycle, patients will receive four weekly doses of ALT-803 
by intravenous injection followed by a 20-day rest period. The rest period may be 
extended to include up to four additional weeks if necessary. Patients who do not 
experience or who sufficiently recover from toxicities of the previous treatment 
cycles will be eligible to continue the treatment included in the study treatment 
plan. 
Treated patients will have up to two anti-tumor evaluation visits. Patients who 
receive at least three study drug doses during the first 2-cycle treatment period will 
be evaluated for anti-tumor response during week 11-12. Patients who have at least 
stable disease from the first anti-tumor evaluation and who meet other criteria to 
continue study treatment will receive up to two additional study treatment cycles, 
with the same treatment schedule and at the same dose level as the first two cycles, 
followed by reassessment for continued tumor response. 
The study treatment and response evaluation schedule is illustrated below: 
Treatment Cycle 
Cycle #1 
REST 
Cycle #2 
Response 
Evaluation 
Cycle #3 
REST 
Cycle #4 
Response 
Evaluation 
Treatment Week 
1 
2 
3 
4 
5-6 
7 
8 
9 10 
11-12 
13 14 15 16 
17-18 
19 
20 21 22 
23-24 
Treatment Day 
1 
8 
15 22 
23-42 
43 50 57 64 
65-84 
85 92 99 106 107-126 127 134 141 148 149-168 
Dose# 
1 
2 
3 
4 
Rest 
weeks 
5 
6 
7 
8 
 
9 10 11 12 
Rest 
weeks 
13 
14 15 16 
 
Response Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
ALT-803 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
There are no restrictions on further therapies, such as chemotherapy, radiation 
therapy or surgery to be used after the protocol-specified therapy. Clearly, post-
study treatments could be of significant clinical benefit in selected patients, and 
these patients will be followed for outcome. 
Enrolled patients will receive the study treatment at qualified cancer treatment 
centers with adequate diagnostic and treatment facilities to provide appropriate 
management of therapy and complications. ALT-803 will be administered by 
intravenous infusion into a central or peripheral vein under the supervision of a 
qualified physician experienced in the use of biologic anti-cancer agents. 
Dose Escalation 
Phase: 
A modified 3 + 3 design will be used for identifying a tolerable dose for phase II 
studies by monitoring patients for DLTs to determine the MTD and for identifying 
an efficacious dose by monitoring patients’ ALC and WBC count to determine the 
MED during the DLT observation period. The dose escalation phase is concluded 
when either the MTD or the MED is determined. A dose level (RP2D) will then be 
designated for Phase II study. There are five escalating dose levels of ALT-803 
and a step-down cohort (-1) with a lower dose level of ALT-803 in the event that 
unexpected toxicity is encountered at the initial dose level. 
 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 8 of 66 
 
Below are the planned dose levels of the study drug during the dose escalation 
phase of the study.  
 
 
 
 
 
 
  
 
Dose limiting toxicity (DLT) is defined as follows: any toxicity that is not clearly 
unrelated to drug administration that is of Grade 3 and does not resolve to Grade 1 
or lower within a week despite the use of medical intervention or that is of Grade 
4, with exceptions described in the study protocol.  
The DLT Observation Period is defined as the duration of the first treatment cycle. 
 
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out 
of 6 patients experienced DLT and that is one level below a dose that was not 
tolerated. 
 
Minimal Efficacious Dose (MED) is defined as a dose level which produces an 
ALC ≥25,000/µL sustained for 14 days or a total WBC ≥35,000/µL sustained for 
14 days among 2/3 or 4/6 of patients. For safety, we have also defined an 
“exceeding MED” as the occurrence of ALC ≥35,000/µL or WBC ≥50,000/µL 
sustained for 14 days. 
 
Expansion 
Phase 
The two-stage expansion phase at the MTD or the MED level will be conducted 
using an optimal Simon’s two-stage design. Objective response (OR) (defined as 
complete response (CR) + partial response (PR)) will be evaluated and set 
thresholds of lack of efficacy (OR rate (ORR) = 10%) and an efficacy level of 
interest (ORR = 30%) will be selected.  
Stopping Rules: 
Patient enrollment will be temporarily suspended based on occurrence of any of 
the following events, and the study committee, including the sponsor, the Data 
Safety Monitoring Board and principal investigators will meet to discuss how to 
proceed with future patient enrollment in the study. 
During the dose escalation phase of the study,  
• If the maximum planned dose level has been reached, but neither the MTD nor 
MED can be determined. 
Cohort 
ALT-803 Dose (µg/kg) 
Number of patients 
-1 
0.5 
3 to 6 
1 (initial) 
1 
3 to 6 
2 
3 
3 to 6 
3 
6 
3 to 6 
4 
10 
3 to 6 
5 
20 
3 to 6 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 9 of 66 
• If de-escalation occurs and the step-down dose level cannot be designated as 
the MTD or MED.  
Any time during the expansion phase of the study,  
• More than 33% of patients experience a possible, probable or definite study 
drug related DLT. 
• Favorable anti-tumor response data collected from enrolled patients. 
At any time during the study, 
The study committee may meet to discuss how to proceed with the study and may 
make any or all of the following recommendations for further patient enrollment:  
• Downward adjust the study drug dose. 
• Adjust the study drug dosing schedule. 
• Recommend more effective pre-therapy, intra-therapy and post-therapy side 
effect mitigation interventions. 
• Correct protocol technical errors that caused unnecessary dose omissions or 
premature treatment discontinuations. After correction of protocol errors, the 
DSMB may meet to re-evaluate the safety profile of the study treatment and 
recommend how to proceed with the study, if necessary. 
Evaluations: 
Patients will be evaluated for clinical toxicities during the treatment. Patients’ 
blood samples will be collected to assess the pharmacokinetic profile and 
immunogenicity of the study drug. The anti-tumor response will be evaluated at 
week 11-12 and week 23-24 from the start of study treatment. All patients who 
receive at least 3 doses of the study drug ALT-803 will be included in the anti-
tumor response evaluation. 
Population: 
Patients of 18 years of age and above with relapsed or refractory multiple 
myeloma. Patients also need to have adequate cardiac, pulmonary, liver and 
kidney functions and have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0, 1 or 2.  
Sample Size: 
A total of up to 30 assessable patients will be accrued to the dose escalation phase of 
the study (Phase Ib). Anticipated enrollment to this phase is 18 patients. Up to an 
additional 23 assessable patients will be enrolled at the expansion phase (Stage 1 
and 2) of the study (Phase II). A total of approximately 41 assessable patients will 
be enrolled to complete the study. Assuming a 20% rate of ineligible or non-
assessable cases, a total of up to 50 patients may be accrued to the study. 
 
Primary 
Endpoints 
For Phase Ib only 
(1) Determination of the MTD or MED and designation of the recommended dose 
level (RP2D) for Phase II study of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
For Phase Ib & II 
(2) Safety profile of ALT-803 in treated patients. 
 
(3) Disease response rate of treated patients.  
Secondary  

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 10 of 66 
Endpoints 
(1) Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, 
the number and phenotype of peripheral blood T (total and subsets) and NK 
cells in treated patients. 
 
(2) Duration of response in treated patients. 
 
(3) Progression free survival of treated patients. 
(4) Overall survival of treated patients. 
(5) Characterization of the immunogenicity and pharmacokinetic profile, 
including serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-
803 in treated patients. 
Pharmacokinetics 
& Biomarkers: 
Fresh blood samples will be collected to assess immune cell levels and phenotype, 
and serum samples for pharmacokinetics, immunogenicity of the study drug ALT-
803, and the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α after ALT-
803 administration in treated patients. Blood samples for pharmacokinetic analysis 
will be taken on the first day of ALT-803 administration in the first study 
treatment cycle. Venous blood will be obtained at Time 0 (before the start of 
infusion), at 30 minutes, and 2, 4, 6 and 24 hours from Time 0 for the assessment 
of ALT-803 serum concentrations. Non-compartmental and compartmental 
analyses will be conducted. In addition, the same blood samples collected for PK 
analysis will be used to assess the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ 
and TNF-α. Fresh blood samples for immune cell levels and phenotype testing 
will be collected before the start of first and fourth dose of study drug infusion in 
each treatment cycle. Bone marrow samples will be collected for future analysis of 
molecular markers associated with responses or resistance to ALT-803 in patients 
with relapsed or refractory multiple myeloma. 
Monitoring Tests: Blood samples for standard chemistry and CBC with differential will be obtained 
at screening, on each study drug infusion day, and at follow-up visits. Blood 
samples for immunogenicity testing for anti-ALT-803 antibodies will be collected 
prior to dosing on the first ALT-803 infusion day and at weeks 7 and 12 from the 
initial dose of study treatment. Blood and urine samples will be collected on each 
follow-up visit for response assessment.  
Response 
Assessment: 
There are at least two response assessments for treated patients: the first 
assessment during week 11-12 and the second assessment during week 23-24 from 
the start of study treatment. After completion of the first two cycles of study 
treatment, patients who have received at least 3 doses of study drug will have the 
first response assessment. After completion of the two additional cycles of study 
treatment, patients, regardless of the number of additional study drug doses 
received, will have the second response assessment. Response assessments will be 
carried out according to the new International Uniform Response Criteria for 
Multiple Myeloma proposed by the International Myeloma Working Group. 
Baseline evaluations should be performed up to 14 days before study treatment 
starts.  
Progression & 
Survival 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 03 
IND 114006 SERIAL# 0003 
 
               
 
 
 
                             February 5, 2014 
Page 11 of 66 
Assessment: 
Progression-free survival, overall survival, and duration of response of all treated 
patients will be assessed every three months during year 1 and then every 6 
months during years 2 and 3 from the start of study treatment, or through the point 
designated as the end of the study follow up. 
Adverse Events: 
All patients will be monitored and evaluated for clinical toxicities during the 
treatment period and queried at each follow-up visit for Adverse Events (AEs). 
Patients may volunteer information concerning AEs. All adverse events will be 
graded by using the NCI Common Terminology Criteria for Adverse Events 
version 4.0 (CTCAE v4.0), and logged in the patient Case Report Form. The study 
centers should report all Serious Adverse Events (SAEs) and all events that trigger 
patient’s study treatment discontinuation to the sponsor via phone, fax or email (or 
a combination) no more than 24 hours after learning of the event. The sponsor will 
use the information to manage and coordinate the dose escalation, cohort 
expansion and patient enrollment. The sponsor will then inform all of the 
participating clinical sites of the current dose level and the number of patients to 
be enrolled at that level, or of any patient enrollment suspension via phone, fax or 
email within 24 hours of learning of the event. The study centers should report all 
other adverse events to the sponsor following the guidelines defined in the study 
protocol. All study drug related AEs that are both serious and unexpected will be 
reported to the FDA in an expedited manner in accordance with 21 CFR §312.32. 
Statistical Plan: 
For each cohort, all AEs will be tabulated and examined and all safety, 
pharmacokinetic and tumor response data will be evaluated. For estimation of 
duration of response and progression free survival, the Kaplan-Meier method will 
be used. P-values of ≤0.05 (two-sided) will be considered to indicate statistical 
significance.  
 
 

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 03 
IND 114006 SERIAL# 0003 
 
          
 
 
 
 
 
              
 
 
 
                 February 5, 2014 
Page 40 of 66 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS 
8.1 
Study calendar 
TESTS & PROCEDURES 
SCREEN/ 
BASELINE1 
TREATMENT 
CYCLE #1 
REST  
TREATMENT 
CYCLE  #2 
1ST RESPONSE 
ASSESSMENT   
TREATMENT CYCLES     
#3 AND #4  
2ND RESPONSE 
ASSESSMENT 
FOLLOW-UPS 
Study Month  
 
1 
 
2 
3 
4-5 
6 
9  
12  
18  
24   30  36   
Study Week  
 
1 
2     3 
4 
5-6 
7  
8 
9 
10 
11-12 
13-22 
23-24 
Any day during the month  
Study Day  
 
1  
8  
15  
22  
23-42 
 43 
50  
57  
 64 
65-84  
85-148 
149-168 
Tolerance Window 
 
+/- 2 days 
23-42 
+/- 2 days 
Any day 
 
Any day 
Medical history 
X 
 
 
 
 
R 
 
E 
 
S 
 
T 
 
 
P 
 
E 
 
R 
 
I 
 
O 
 
R 
 
 
 
 
 
Follow Institution’s 
standard of care (SOC) 
policy.  
If performed, follow the 
same schedule as in the 
first two cycles of study 
treatment. 
 
 
 
Serum pregnancy test2 
X 
 
 
 
 
 
 
 
 
 
 
Complete physical exam 
X 
X 
 
 
 
X 
 
 
 
X 
X 
Vital signs, Weight, Height3, Cardiac & Lung 
function monitoring  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concurrent medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event assessment4 
X 
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC with Differential 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Blood Chemistry  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
EKG 
X 
X5 
 
X 
 
 
 
 
 
PFT only when clinically indicated 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Response evaluation6 
  
  
 
X 
  
X 
 
Serum quantitative immunoglobulins 
X 
X 
X 
SPEP 
X  
X 
X 
UPEP-random  
X 
X 
X 
SIFE 
X 
X 
X 
UIFE -random 
X 
X 
X 
Serum FLC assay6.1 
X  
X 
X 
Bone marrow plasma cell percentage6.2 
X  
X 
X 
Bone marrow immunohistochemistry or 
immunofluorescence6.3 
 
X 
X 
Soft tissue plasmacytomas assessment6.4 
 
X 
X 
Disease & survival follow-up/post-therapies7 
 
  
 
 X  
X 
X 
X 
X 
X 
Immune cell levels & phenotype8, 11 
 
X8 
 
 
X8 
X8 
 
 
X8 
 
 
 
 
PKx, IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α9,11 
 
X9 
 
 
 
 
 
 
 
 
Immunogenicity tests10, 11 
 
X10 
 
 
 
X 
 
 
 
X 
Study drug (ALT-803)
 
a1 
a2 
a3 
a4 
a5 
a6 
a7 
a8 
 
Follow the same schedule 
as in the first 2 cycles of study 
treatment 
1Screening/baseline evaluations are performed < 14 days prior to start of therapy.  If the patient's condition is deteriorating, ECOG status and laboratory evaluations should be repeated within 48 hours prior to 
initiation of study treatment infusion.  2Pregnancy test is for women with childbearing potential only.  3Vital signs (especially blood pressure), clinical status and laboratory tests should be reviewed before start of 
therapy. Day 1 for the 1st patient of each cohort will have vital signs evaluated at 15, 30, 60 and 120 min then hourly for 6 hours post infusion and every 3 hours thereafter until discharge (24 hrs). Vital signs for the 
rest of the study visits and all visits for subsequent patients will be evaluated at 15, 30, 60 and 120 min and then hourly post infusion until discharge (or at completion of dose monitoring) from the clinic. Body weight 
will be collected before infusion on each drug infusion day for all patients. 4Patients who have an on-going study drug-related SAE upon study completion or at discontinuation of study will be contacted by the 
investigator or his/her designee every week until the event is resolved or determined to be irreversible. 5If the screening EKG was performed within 14 days prior to start of study treatment, the EKG is not required. 
6Disease response and progression assessment will be evaluated using the new International Uniform Response Criteria for Multiple Myeloma proposed by the International Myeloma Working Group. 6.1Only when serum 
and urine M-protein are unmeasurable. 6.2 Only when serum and urine M-protein and serum FLC are unmeasurable and bone marrow plasma cell percentage > 30% at baseline. 6.3Only when sCR is to be determined. 
6.4Only when present at baseline, and to confirm CR or PR by X-rays, MRI or CT scans. 7Information about tumor assessment & other therapies received after completion of study treatment will be collected if 
available.  8Fresh blood samples for immune cell levels & phenotype testing will be collected before dosing. 9Collect blood samples at Time 0 (before drug infusion), at 30 min (+/- 5 min), 2 hour (+/- 15 min), 4 hour 
(+/- 30 min), 6 hour (+/- 60 min) , 24 hour (+/- 6 hour)- from Time 0.  IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α assays are performed using the same samples and at the same schedule as PK.  10Use the sample 
collected before dosing for PK test. 11Residual samples may be used by Sponsor for research studies of other biomarkers. xThe last PK sample will be collected on the next day. 

CLINICAL STUDY PROTOCOL 
Protocol Number: 
CA-ALT-803-02-13 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed 
or Refractory Multiple Myeloma 
Date of Protocol: 
Version# 01 
Version# 02 
Version# 03 
Version# 04 
January 7, 2014 
February 3, 2014 
February 5, 2014 
May 16, 2014 
Sponsor Contact: 
Hing C. Wong, Ph.D. 
Altor Bioscience Corporation. 
Miramar, Florida 33025 
Telephone: 
954-443-8600
Safety Data Fax: 
954-443-8602

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 3 of 67 
 
 
Table of Contents 
SYNOPSIS ................................................................................................................................................................6 
1. 
OBJECTIVES ................................................................................................................................................12 
1.1 
PRIMARY OBJECTIVES .............................................................................................................................12 
1.2 
SECONDARY OBJECTIVES ........................................................................................................................12 
2. 
BACKGROUND ............................................................................................................................................12 
2.1 
ALT-803 – GENERAL INFORMATION.......................................................................................................12 
2.2 
MULTIPLE MYELOMA .............................................................................................................................13 
2.3 
IMMUNE-BASED THERAPIES FOR CANCER ...............................................................................................13 
2.4 
PHARMACOLOGICAL EFFECTS OF ALT-803 IN VITRO AND IN ANIMALS ..................................................14 
 
Development of ALT-803 (IL-15N72D:IL-15RαSu/IgG1 Fc complex) .............................................................. 14 
2.4.1
 
In vitro biological activity of ALT-803 ............................................................................................................... 15 
2.4.2
 
In vivo biological activity of ALT-803 ............................................................................................................... 15 
2.4.3
 
Potent anti-tumor activity of ALT-803 in mouse models .................................................................................... 16 
2.4.4
 
Anti-myeloma mechanism of action of ALT-803 ................................................................................................ 17 
2.4.5
2.5 
NON-CLINICAL TOXICOLOGY ..................................................................................................................17 
 
Multi-dose toxicity studies in mice ..................................................................................................................... 17 
2.5.1
 
Multi-dose toxicity studies in cynomolgus monkeys ........................................................................................... 18 
2.5.2
2.6 
PHARMACOKINETICS ...............................................................................................................................19 
 
Non-clinical pharmacokinetics .......................................................................................................................... 19 
2.6.1
 
Clinical pharmacokinetics ................................................................................................................................. 20 
2.6.2
2.7 
RATIONALE FOR HUMAN CLINICAL STARTING DOSE ...............................................................................20 
2.8 
HUMAN EXPERIENCE ...............................................................................................................................20 
3. 
RATIONALE FOR THE CURRENT STUDY ...........................................................................................21 
4. 
OVERALL STUDY DESIGN .......................................................................................................................22 
5. 
STUDY POPULATION ................................................................................................................................24 
5.1 
INCLUSION CRITERIA ...............................................................................................................................24 
5.2 
EXCLUSION CRITERIA ..............................................................................................................................25 
5.3 
INCLUSION OF WOMEN AND MINORITIES .................................................................................................25 
6. 
STUDY DESIGN ...........................................................................................................................................26 
6.1 
STUDY FLOW DIAGRAM ...........................................................................................................................26 
6.2 
SCREENING AND ENROLLMENT ...............................................................................................................26 
6.3 
STUDY TREATMENT .................................................................................................................................26 
 
Treatment setting ............................................................................................................................................... 27 
6.3.1
 
Treatment regimen and study scheme ................................................................................................................ 27 
6.3.2
 
Study drug preparation ...................................................................................................................................... 27 
6.3.3
 
Study drug administration .................................................................................................................................. 27 
6.3.4
 
Pre and post-therapy intervention guidelines .................................................................................................... 28 
6.3.5
6.4 
DURATION OF PATIENT PARTICIPATION ..................................................................................................29 
6.5 
DOSE ESCALATION PHASE .......................................................................................................................29 
6.6 
EXPANSION PHASE ..................................................................................................................................30 
6.7 
STOPPING RULES .....................................................................................................................................31 
 
During dose escalation phase of the study ......................................................................................................... 31 
6.7.1
 
During expansion phase of the study ................................................................................................................. 31 
6.7.2
 
At any time during the study .............................................................................................................................. 31 
6.7.3
6.8 
PATIENT MONITORING, RESPONSE EVALUATION, TREATMENT CYCLE #3 AND #4, DISEASE PROGRESSION 
& SURVIVAL FOLLOW-UP .....................................................................................................................................32 
 
Patient monitoring ............................................................................................................................................. 32 
6.8.1
 
Response evaluation ........................................................................................................................................... 32 
6.8.2

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 4 of 67 
 
 
Treatment cycle #3 & #4 .................................................................................................................................... 32 
6.8.3
 
Disease progression and survival follow-up ...................................................................................................... 32 
6.8.4
6.9 
DOSE LIMITING TOXICITY ........................................................................................................................32 
 
Definition of dose limiting toxicity ..................................................................................................................... 32 
6.9.1
 
Definition of maximum tolerated dose (MTD) ................................................................................................... 33 
6.9.2
 
Definition of minimal efficacious dose (MED) .................................................................................................. 33 
6.9.3
6.10 
STUDY TREATMENT DISCONTINUATION ..................................................................................................33 
 
Study treatment discontinuation events ......................................................................................................... 33 
6.10.1
 
Replacement of participants .......................................................................................................................... 34 
6.10.2
 
Follow-ups after treatment discontinuation .................................................................................................. 35 
6.10.3
6.10.3.1. 
Discontinuation due to SAEs or on-going study drug related AEs .......................................................... 35 
6.10.3.2. 
Discontinuation due to any other reasons ................................................................................................. 35 
6.11 
STUDY TREATMENT INTERRUPTION ........................................................................................................35 
 
Kidney dysfunction ........................................................................................................................................ 35 
6.11.1
 
Hematological dysfunction ............................................................................................................................ 35 
6.11.2
 
Hypotension .................................................................................................................................................. 35 
6.11.3
 
Allergic reactions and cytokine release syndrome/acute infusion reaction .................................................. 36 
6.11.4
6.12 
GENERAL SUPPORTIVE CARE GUIDELINES AND DRUG INTERACTION ......................................................36 
 
Hypotension and capillary leak syndrome .................................................................................................... 36 
6.12.1
 
Pulmonary dysfunction .................................................................................................................................. 37 
6.12.2
 
Impaired kidney and liver functions .............................................................................................................. 37 
6.12.3
 
Infection ........................................................................................................................................................ 37 
6.12.4
 
Fever and chills ............................................................................................................................................. 37 
6.12.5
 
Gastritis ......................................................................................................................................................... 37 
6.12.6
 
Diarrhea, nausea and vomiting ..................................................................................................................... 37 
6.12.7
 
Pruritus and dermatitis ................................................................................................................................. 37 
6.12.8
 
Acidosis ......................................................................................................................................................... 37 
6.12.9
 
Life-threatening toxicities ............................................................................................................................. 37 
6.12.10
 
Other supportive care ................................................................................................................................... 37 
6.12.11
 
Drug interaction ............................................................................................................................................ 37 
6.12.12
7. 
STUDY DRUG: AVAILABILITY, ACCOUNTABILITY, PACKAGING & LABELING ...................39 
7.1 
AVAILABILITY .........................................................................................................................................39 
7.2 
ACCOUNTABILITY ...................................................................................................................................39 
7.3 
PACKAGING .............................................................................................................................................39 
7.4 
LABELING ................................................................................................................................................39 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS ................................................................40 
8.1 
STUDY CALENDAR ...................................................................................................................................40 
8.2 
PROCEDURE AND TESTS ..........................................................................................................................42 
 
Assays for immune cell levels and phenotype .................................................................................................... 42 
8.2.1
 
Medical history & prior therapy ........................................................................................................................ 42 
8.2.2
 
Pregnancy test .................................................................................................................................................... 42 
8.2.3
 
Physical examination ......................................................................................................................................... 42 
8.2.4
 
Vital signs, body weight & height ...................................................................................................................... 42 
8.2.5
 
Cardiac assessment ............................................................................................................................................ 42 
8.2.6
 
Pulmonary function monitoring ......................................................................................................................... 43 
8.2.7
 
Clinical blood tests ............................................................................................................................................ 43 
8.2.8
 
Disease assessment tests and procedures .......................................................................................................... 43 
8.2.9
 
Adverse event assessment .............................................................................................................................. 43 
8.2.10
 
Response assessment ..................................................................................................................................... 43 
8.2.11
 
Disease progression and survival follow-up ................................................................................................. 44 
8.2.12
 
Pharmacokinetic (PK) testing ....................................................................................................................... 44 
8.2.13
 
Biomarker assays for IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α .................................................................. 44 
8.2.14
 
Immunogenicity tests - detection of anti-ALT-803 antibodies ....................................................................... 44 
8.2.15
9. 
MEASUREMENT OF EFFECT ..................................................................................................................45 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 5 of 67 
 
9.1 
MEASURABLE DISEASE ............................................................................................................................45 
9.2 
EFFECT ASSESSMENT SCHEDULE .............................................................................................................45 
9.3 
METHODOLOGY OF RESPONSE EVALUATION ..........................................................................................45 
9.4 
RESPONSE EVALUATION CRITERIA ..........................................................................................................46 
9.5 
DISEASE PROGRESSION EVALUATION CRITERIA ......................................................................................47 
10. 
STATISTICAL ANALYSIS .....................................................................................................................48 
10.1 
STUDY OBJECTIVES .................................................................................................................................48 
10.2 
SAMPLE SIZE ............................................................................................................................................48 
10.3 
DATA COLLECTION ..................................................................................................................................48 
10.4 
DATA ANALYSIS ......................................................................................................................................48 
 
Analysis of safety ........................................................................................................................................... 49 
10.4.1
 
Analysis of response ...................................................................................................................................... 49 
10.4.2
 
Pharmacokinetics .......................................................................................................................................... 49 
10.4.3
11. 
REGULATORY AND REPORTING REQUIREMENTS ....................................................................50 
11.1 
ADVERSE EVENTS RECORDING, REPORTING AND COMMUNICATION .......................................................50 
11.2 
ADVERSE EVENT TERMINOLOGY AND DEFINITIONS ................................................................................50 
11.3 
ADVERSE EVENT REPORTING PROCEDURES ...........................................................................................51 
11.4 
ADVERSE EVENT EXPEDITED REPORTING GUIDELINES ..........................................................................52 
11.5 
SUBMISSION OF SERIOUS ADVERSE EVENT REPORTING ...........................................................................52 
11.6 
DATA REPORTING FORMS .......................................................................................................................52 
11.7 
REPORT /DATA SUBMISSION ADDRESS & CONTACT ................................................................................53 
11.8 
PATIENT RECORDS, QUALITY ASSURANCE, RECORDS RETENTION ..........................................................53 
11.9 
METHOD OF REVIEW ...............................................................................................................................53 
11.10 
SPECIAL REGULATORY CONSIDERATIONS ...........................................................................................54 
 
HIPAA ........................................................................................................................................................... 54 
11.10.1
 
Protocol amendments, informed consent, and IRB approval ........................................................................ 54 
11.10.2
12. 
CONFIDENTIALITY ...............................................................................................................................54 
13. 
ETHICAL STANDARDS & INVESTIGATOR OBLIGATIONS .......................................................54 
14. 
LIST OF EXPECTED ADVERSE EVENTS ..........................................................................................55 
15. 
CTCAE .......................................................................................................................................................57 
REFERENCES .......................................................................................................................................................58 
APPENDIX A: ECOG ...........................................................................................................................................60 
APPENDIX B: NEW YORK HEART ASSOCIATION CLASSIFICATION .................................................60 
APPENDIX C: ETHICAL STANDARDS ...........................................................................................................61 
APPENDIX D: INVESTIGATOR OBLIGATIONS ...........................................................................................62 
APPENDIX E: CONTACT LIST - ALTOR ........................................................................................................66 
APPENDIX F: CONTACT LIST – DATA SAFETY MONITORING BOARD (DSMB) ...............................67 
APPENDIX G: CONTACT LIST - LABORATORIES......................................................................................67 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 6 of 67 
SYNOPSIS 
Sponsor: 
Altor Bioscience Corporation 
Protocol#: 
CA-ALT-803-02-13 
Study Drug Name: Not applicable 
Study Treatment 
Active agents: 
ALT-803, a “recombinant human super agonist interleukin-15 (IL-15) complex” 
(AKA, IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
Study Type: 
Interventional 
Study Phase: 
I/II 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed or Refractory Multiple Myeloma 
Objectives: 
To evaluate the safety and tolerability of escalating doses, identify the Maximum 
Tolerated Dose level (MTD) or Minimum Efficacious Dose (MED) and designate 
a dose level for Phase II study (RP2D) of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
 
To evaluate the effect of ALT-803 on the peripheral absolute lymphocyte counts 
(ALC) and white blood cell (WBC) counts, the number and phenotype of 
peripheral blood T (total and subsets) and NK cells. 
To estimate the anti-tumor activity of ALT-803 by radiologic or pathologic disease 
response, progression free survival, and overall survival in treated patients.  
To characterize the immunogenicity and pharmacokinetic profile, including serum 
levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-803 in treated 
patients. 
 
Study Design: 
This is a Phase I/II, open-label, multi-center, competitive enrollment and dose-
escalation study of ALT-803 in patients with relapsed or refractory multiple 
myeloma. 
 
The study includes a dose escalation phase to determine the MTD or MED using a 
modified classic (3+3) dose escalation design and to designate a dose level for the 
Phase II expansion phase (RP2D) and a two-stage expansion phase at the RP2D 
using a Simon two-stage design. In Phase I, five dose levels will be evaluated. A 
step-down dose level (cohort# -1) will be provided in the event of encountering 
DLT in two patients at the planned initial dose level. In the absence of 
unacceptable toxicity or disease progression, each enrolled patient will receive up 
to four 6-week study treatment cycles, each consisting of a 4-week treatment 
period and a 2-week rest period. In each cycle, patients will receive four doses of 
ALT-803 by intravenous injection weekly for 4 weeks followed by a 2-week rest 
period. Patients with sufficient recovery of toxicities from the previous treatment 
cycles will be eligible to continue study treatment. After receiving two treatment 
cycles, patients who have at least stable disease assessed at week 11-12 may 
receive up to two additional study treatment cycles followed by reassessment for 
continued tumor response. 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 7 of 67 
The study will be conducted in conformity with Good Clinical Practice (GCP).  
 
Treatments:  
The study treatment plan for each enrolled patient includes up to four 6-week study 
treatment cycles. In each cycle, patients will receive four weekly doses of ALT-803 
by intravenous injection followed by a 2-week rest period. The rest period may be 
extended to include up to four additional weeks if necessary. Patients who do not 
experience or who sufficiently recover from toxicities of the previous treatment 
cycles will be eligible to continue the treatment included in the study treatment 
plan. 
Treated patients will have up to two anti-tumor evaluation visits. Patients who 
receive at least three study drug doses during the first 2-cycle treatment period will 
be evaluated for anti-tumor response during week 11-12. Patients who have at least 
stable disease from the first anti-tumor evaluation and who meet other criteria to 
continue study treatment will receive up to two additional study treatment cycles, 
with the same treatment schedule and at the same dose level as the first two cycles, 
followed by reassessment for continued tumor response. 
The study treatment and response evaluation schedule is illustrated below: 
Treatment Cycle 
Cycle #1 
REST 
Cycle #2 
Response 
Evaluation 
Cycle #3 
REST 
Cycle #4 
Response 
Evaluation 
Treatment Week 
1 
2 
3 
4 
5-6 
7 
8 
9 10 
11-12 
13 14 15 16 
17-18 
19 
20 21 22 
23-24 
Treatment Day 
1 
8 
15 22 
23-42 
43 50 57 64 
71-84 
85 92 99 106 107-126 127 134 141 148 155-168 
Dose# 
1 
2 
3 
4 
Rest 
weeks 
5 
6 
7 
8 
 
9 10 11 12 
Rest 
weeks 
13 
14 15 16 
 
Response Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
ALT-803 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
There are no restrictions on further therapies, such as chemotherapy, radiation 
therapy or surgery to be used after the protocol-specified therapy. Clearly, post-
study treatments could be of significant clinical benefit in selected patients, and 
these patients will be followed for outcome. 
Enrolled patients will receive the study treatment at qualified cancer treatment 
centers with adequate diagnostic and treatment facilities to provide appropriate 
management of therapy and complications. ALT-803 will be administered by 
intravenous infusion into a central or peripheral vein under the supervision of a 
qualified physician experienced in the use of biologic anti-cancer agents. 
Dose Escalation 
Phase: 
A modified 3 + 3 design will be used for identifying a tolerable dose for phase II 
studies by monitoring patients for DLTs to determine the MTD and for identifying 
an efficacious dose by monitoring patients’ ALC and WBC count to determine the 
MED during the DLT observation period. The dose escalation phase is concluded 
when either the MTD or the MED is determined. A dose level (RP2D) will then be 
designated for Phase II study. There are five escalating dose levels of ALT-803 
and a step-down cohort (-1) with a lower dose level of ALT-803 in the event that 
unexpected toxicity is encountered at the initial dose level. 
 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 8 of 67 
 
Below are the planned dose levels of the study drug during the dose escalation 
phase of the study.  
 
 
 
 
 
 
  
 
Dose limiting toxicity (DLT) is defined as follows: any toxicity that is not clearly 
unrelated to drug administration that is of Grade 3 and does not resolve to Grade 1 
or lower within a week despite the use of medical intervention or that is of Grade 
4, with exceptions described in the study protocol.  
The DLT Observation Period is defined as the duration of the first treatment cycle. 
 
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out 
of 6 patients experienced DLT and that is one level below a dose that was not 
tolerated. 
 
Minimal Efficacious Dose (MED) is defined as a dose level which produces an 
ALC ≥25,000/µL sustained for 14 days or a total WBC ≥35,000/µL sustained for 
14 days among 2/3 or 4/6 of patients. For safety, we have also defined an 
“exceeding MED” as the occurrence of ALC ≥35,000/µL or WBC ≥50,000/µL 
sustained for 14 days. 
 
Expansion 
Phase 
The two-stage expansion phase at the MTD or the MED level will be conducted 
using an optimal Simon’s two-stage design. Objective response (OR) (defined as 
complete response (CR) + partial response (PR)) will be evaluated and set 
thresholds of lack of efficacy (OR rate (ORR) = 10%) and an efficacy level of 
interest (ORR = 30%) will be selected.  
Stopping Rules: 
Patient enrollment will be temporarily suspended based on occurrence of any of 
the following events, and the study committee, including the sponsor, the Data 
Safety Monitoring Board and principal investigators will meet to discuss how to 
proceed with future patient enrollment in the study. 
During the dose escalation phase of the study,  
• If the maximum planned dose level has been reached, but neither the MTD nor 
MED can be determined. 
Cohort 
ALT-803 Dose (µg/kg) 
Number of patients 
-1 
0.5 
3 to 6 
1 (initial) 
1 
3 to 6 
2 
3 
3 to 6 
3 
6 
3 to 6 
4 
10 
3 to 6 
5 
20 
3 to 6 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 9 of 67 
• If de-escalation occurs and the step-down dose level cannot be designated as 
the MTD or MED.  
Any time during the expansion phase of the study,  
• More than 33% of patients experience a possible, probable or definite study 
drug related DLT. 
• Favorable anti-tumor response data collected from enrolled patients. 
At any time during the study, 
The study committee may meet to discuss how to proceed with the study and may 
make any or all of the following recommendations for further patient enrollment:  
• Downward adjust the study drug dose. 
• Adjust the study drug dosing schedule. 
• Recommend more effective pre-therapy, intra-therapy and post-therapy side 
effect mitigation interventions. 
• Correct protocol technical errors that caused unnecessary dose omissions or 
premature treatment discontinuations. After correction of protocol errors, the 
DSMB may meet to re-evaluate the safety profile of the study treatment and 
recommend how to proceed with the study, if necessary. 
Evaluations: 
Patients will be evaluated for clinical toxicities during the treatment. Patients’ 
blood samples will be collected to assess the pharmacokinetic profile and 
immunogenicity of the study drug. The anti-tumor response will be evaluated at 
week 11-12 and week 23-24 from the start of study treatment. All patients who 
receive at least 3 doses of the study drug ALT-803 will be included in the anti-
tumor response evaluation. 
Population: 
Patients of 18 years of age and above with relapsed or refractory multiple 
myeloma. Patients also need to have adequate cardiac, pulmonary, liver and 
kidney functions and have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0, 1 or 2.  
Sample Size: 
A total of up to 30 assessable patients will be accrued to the dose escalation phase of 
the study (Phase I). Anticipated enrollment to this phase is 18 patients. Up to an 
additional 23 assessable patients will be enrolled at the expansion phase (Stage 1 
and 2) of the study (Phase II). An estimated total of approximately 41 assessable 
patients will be enrolled to complete the study. Assuming a 20% rate of ineligible 
or non-assessable cases, an estimated total of up to 50 patients may be accrued to 
the study. 
 
Primary 
Endpoints 
For Phase I only 
(1) Determination of the MTD or MED and designation of the recommended dose 
level (RP2D) for Phase II study of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
For Phase I & II 
(2) Safety profile of ALT-803 in treated patients. 
 
(3) Disease response rate of treated patients.  

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 10 of 67 
Secondary  
Endpoints 
(1) Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, 
the number and phenotype of peripheral blood T (total and subsets) and NK 
cells in treated patients. 
 
(2) Duration of response in treated patients. 
 
(3) Progression free survival of treated patients. 
(4) Overall survival of treated patients. 
(5) Characterization of the immunogenicity and pharmacokinetic profile, 
including serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α, of ALT-
803 in treated patients. 
Pharmacokinetics 
& Biomarkers: 
Fresh blood samples will be collected to assess immune cell levels and phenotype, 
and serum samples for pharmacokinetics, immunogenicity of the study drug ALT-
803, and the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α after ALT-
803 administration in treated patients. Blood samples for pharmacokinetic analysis 
will be taken on the first day of ALT-803 administration in the first study 
treatment cycle. Venous blood will be obtained at Time 0 (before the start of 
infusion), at 30 minutes, and 2, 4, 6 and 24 hours from Time 0 for the assessment 
of ALT-803 serum concentrations. Non-compartmental and compartmental 
analyses will be conducted. In addition, the same blood samples collected for PK 
analysis will be used to assess the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ 
and TNF-α. Fresh blood samples for immune cell levels and phenotype testing 
will be collected before the start of first and fourth dose of study drug infusion in 
each treatment cycle. Bone marrow samples will be collected for future analysis of 
molecular markers associated with responses or resistance to ALT-803 in patients 
with relapsed or refractory multiple myeloma. 
Monitoring Tests: Blood samples for standard chemistry and CBC with differential will be obtained 
at screening, on each study drug infusion day, and at follow-up visits. Blood 
samples for immunogenicity testing for anti-ALT-803 antibodies will be collected 
prior to dosing on the first ALT-803 infusion day, at week 7 and at the first 
assessment during week 11-12  from the initial dose of study treatment. Blood and 
urine samples will be collected on each follow-up visit for response assessment.  
Response 
Assessment: 
There are at least two response assessments for treated patients: the first 
assessment during week 11-12 and the second assessment during week 23-24 from 
the start of study treatment. After completion of the first two cycles of study 
treatment, patients who have received at least 3 doses of study drug will have the 
first response assessment. After completion of the two additional cycles of study 
treatment, patients, regardless of the number of additional study drug doses 
received, will have the second response assessment. Response assessments will be 
carried out according to the new International Uniform Response Criteria for 
Multiple Myeloma proposed by the International Myeloma Working Group. 
Baseline evaluations should be performed up to 14 days before study treatment 
starts.  
Progression & 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 04 
IND 114006 SERIAL# 0004 
 
               
 
 
 
                                   May 16, 2014 
Page 11 of 67 
Survival 
Assessment: 
Progression-free survival, overall survival, and duration of response of all treated 
patients will be assessed every three months during year 1 and then every 6 
months during years 2 and 3 from the start of study treatment, or through the point 
designated as the end of the study follow up. 
Adverse Events: 
All patients will be monitored and evaluated for clinical toxicities during the 
treatment period and queried at each follow-up visit for Adverse Events (AEs). 
Patients may volunteer information concerning AEs. All adverse events will be 
graded by using the NCI Common Terminology Criteria for Adverse Events 
version 4.0 (CTCAE v4.0), and logged in the patient Case Report Form. The study 
centers should report all Serious Adverse Events (SAEs) and all events that trigger 
patient’s study treatment discontinuation to the sponsor via phone, fax or email (or 
a combination) no more than 24 hours after learning of the event. The sponsor will 
use the information to manage and coordinate the dose escalation, cohort 
expansion and patient enrollment. The sponsor will then inform all of the 
participating clinical sites of the current dose level and the number of patients to 
be enrolled at that level, or of any patient enrollment suspension via phone, fax or 
email within 24 hours of learning of the event. The study centers should report all 
other adverse events to the sponsor following the guidelines defined in the study 
protocol. All study drug related AEs that are both serious and unexpected will be 
reported to the FDA in an expedited manner in accordance with 21 CFR §312.32. 
Statistical Plan: 
For each cohort, all AEs will be tabulated and examined and all safety, 
pharmacokinetic and tumor response data will be evaluated. For estimation of 
duration of response and progression free survival, the Kaplan-Meier method will 
be used. P-values of ≤0.05 (two-sided) will be considered to indicate statistical 
significance.  
 
 

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 04 
IND 114006 SERIAL# 0004 
 
          
 
 
 
 
 
              
 
 
 
                       May 16, 2014 
Page 40 of 67 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS 
8.1 
Study calendar 
TESTS & PROCEDURES 
SCREEN/ 
BASELINE1 
TREATMENT 
CYCLE #1 
REST  
TREATMENT 
CYCLE  #2 
1ST RESPONSE 
ASSESSMENT   
TREATMENT CYCLES     
#3 AND #4  
2ND RESPONSE 
ASSESSMENT 
FOLLOW-UPS 
Study Month  
 
1 
2 
2 - 3 
3 
4-5 
6 
9  
12  
18  
24   30  36   
Study Week  
 
1 
2     3 
4 
5-6 
7  
8 
9 
10 
11-12 
13-22 
23-24 
± 1 week 
Study Day  
 
1  
8  
15  
22  
23-42 
 43 
50  
57  
 64 
71-84  
85-148 
155-168 
Tolerance Window 
 
+/- 2 days 
23-42 
+/- 2 days 
Any day 
 
Any day 
Medical history 
X 
 
 
 
 
R 
 
E 
 
S 
 
T 
 
 
P 
 
E 
 
R 
 
I 
 
O 
 
D 
 
 
 
 
 
Follow Institution’s 
standard of care (SOC) 
policy.  
If performed, follow the 
same schedule as in the 
first two cycles of study 
treatment. 
 
 
 
Serum pregnancy test2 
X 
 
 
 
 
 
 
 
 
 
 
Complete physical exam 
X 
X 
 
 
 
X 
 
 
 
X 
X 
Vital signs, Weight, Height3, Cardiac & Lung 
function monitoring  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concurrent medication 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse event assessment4 
X 
X  
X 
X 
X 
X 
X 
X 
X 
X 
X 
CBC with Differential13 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Blood Chemistry13  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
EKG 
X 
X5 
 
X 
 
 
 
 
 
PFT only when clinically indicated 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Response evaluation6 
  
  
 
X 
  
X 
 
Serum quantitative immunoglobulins 
X 
X 
X 
SPEP 
X  
X 
X 
UPEP-random  
X 
X 
X 
SIFE 
X 
X 
X 
UIFE -random 
X 
X 
X 
Serum FLC assay6.1 
X  
X 
X 
Bone marrow plasma cell percentage6.2 
X  
X 
X 
Bone marrow immunohistochemistry or 
immunofluorescence6.3 
 
X 
X 
Soft tissue plasmacytomas assessment6.4 
 
X 
X 
Disease & survival follow-up/post-therapies7 
 
  
 
 X  
X 
X 
X 
X 
X 
Immune cell levels & phenotype8, 11 
 
X8 
 
 
X8 
X8 
 
 
X8 
 
 
 
 
PK12, IL-2, IL-4, IL-6, IL-10, IFN-γ, TNF-α9,11 
 
X9 
 
 
 
 
 
 
 
 
Immunogenicity tests10, 11 
 
X10 
 
 
 
X 
 
 
 
X 
Study drug (ALT-803) 
 
a1 
a2 
a3 
a4 
a5 
a6 
a7 
a8 
 
Follow the same schedule 
as in the first 2 cycles of study 
treatment 
1Screening/baseline evaluations are performed < 14 days prior to start of therapy.  If the patient's condition is deteriorating, ECOG status and laboratory evaluations should be repeated within 48 hours prior to initiation 
of study treatment infusion.  2Pregnancy test is for women with childbearing potential only.  3Vital signs (especially blood pressure), clinical status and laboratory tests should be reviewed before start of therapy. Day 1 
for the 1st patient of each cohort will have vital signs evaluated at 15, 30, 60 and 120 min then hourly for 6 hours post infusion and every 3 hours thereafter until discharge (24 hrs). Vital signs for the rest of the study 
visits and all visits for subsequent patients will be evaluated at 15, 30, 60 and 120 min and then hourly post infusion until discharge (or at completion of dose monitoring) from the clinic. Body weight will be collected 
before infusion on each drug infusion day for all patients. 4Patients who have an on-going study drug-related SAE upon study completion or at discontinuation of study will be contacted by the investigator or his/her 
designee every week until the event is resolved or determined to be irreversible. 5If the screening EKG was performed within 14 days prior to start of study treatment, the EKG is not required. 6Disease response and 
progression assessment will be evaluated using the new International Uniform Response Criteria for Multiple Myeloma proposed by the International Myeloma Working Group. 6.1Only when serum and urine M-protein are 
unmeasurable. 6.2 Only when serum and urine M-protein and serum FLC are unmeasurable and bone marrow plasma cell percentage > 30% at baseline. 6.3Only when sCR is to be determined. 6.4Only when present at 
baseline, and to confirm CR or PR by X-rays, MRI or CT scans. 7Information about tumor assessment & other therapies received after completion of study treatment will be collected if available.  8Fresh blood samples 
for immune cell levels & phenotype testing will be collected before dosing. 9Collect blood samples at Time 0 (before drug infusion), at 30 min (+/- 5 min), 2 hour (+/- 15 min), 4 hour (+/- 30 min), 6 hour (+/- 60 min) , 
24 hour (+/- 6 hour)- from Time 0.  IL-2, IL-4, IL-6, IL-10, IFN-γ and TNF-α assays are performed using the same samples and at the same schedule as PK.  10Use the sample collected before dosing for PK test. 
11Residual samples may be used by Sponsor for research studies of other biomarkers. All attempts will be made to collect research samples but missed samples will not be considered a protocol deviation.   

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 04 
IND 114006 SERIAL# 0004 
 
          
 
 
 
 
 
              
 
 
 
                       May 16, 2014 
Page 41 of 67 
12The last PK sample will be collected on the next day. 13Safety labs can be drawn within 24 hours of scheduled dose. 

CLINICAL STUDY PROTOCOL 
Protocol Number: 
CA-ALT-803-02-13 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed 
or Refractory Multiple Myeloma 
Date of Protocol: 
Version# 01 
Version# 02 
Version# 03 
Version# 04 
Version# 05 
January 7, 2014 
February 3, 2014 
February 5, 2014 
May 16, 2014 
December 17, 2015 
Sponsor Contact: 
Hing C. Wong, Ph.D. 
Altor Bioscience Corporation. 
Miramar, Florida 33025 
Telephone: 
954-443-8600
Safety Data Fax: 
954-443-8602

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 3 of 72 
 
 
Table of Contents 
SYNOPSIS ................................................................................................................................................................6 
1. 
OBJECTIVES ................................................................................................................................................12 
1.1 
PRIMARY OBJECTIVES .............................................................................................................................12 
1.2 
SECONDARY OBJECTIVES ........................................................................................................................12 
2. 
BACKGROUND ............................................................................................................................................12 
2.1 
ALT-803 – GENERAL INFORMATION.......................................................................................................12 
2.2 
MULTIPLE MYELOMA .............................................................................................................................13 
2.3 
IMMUNE-BASED THERAPIES FOR CANCER ...............................................................................................13 
2.4 
PHARMACOLOGICAL EFFECTS OF ALT-803 IN VITRO AND IN ANIMALS ..................................................14 
 
Development of ALT-803 (IL-15N72D:IL-15RαSu/IgG1 Fc complex) .............................................................. 14 
2.4.1
 
In vitro biological activity of ALT-803 ............................................................................................................... 15 
2.4.2
 
In vivo biological activity of ALT-803 ............................................................................................................... 15 
2.4.3
 
Potent anti-tumor activity of ALT-803 in mouse models .................................................................................... 16 
2.4.4
 
Anti-myeloma mechanism of action of ALT-803 ................................................................................................ 17 
2.4.5
2.5 
NON-CLINICAL TOXICOLOGY ..................................................................................................................17 
 
Multi-dose toxicity studies in mice ..................................................................................................................... 17 
2.5.1
 
Multi-dose toxicity studies in cynomolgus monkeys ........................................................................................... 18 
2.5.2
2.6 
COMPARATIVE STUDIES OF INTRAVENOUS AND SUBCUTANEOUS ALT-803 ...........................................19 
2.7 
PHARMACOKINETICS ...............................................................................................................................20 
 
Non-clinical pharmacokinetics .......................................................................................................................... 20 
2.7.1
2.8 
RATIONALE FOR HUMAN CLINICAL STARTING DOSE ...............................................................................21 
2.9 
HUMAN EXPERIENCE ...............................................................................................................................21 
3. 
RATIONALE FOR THE CURRENT STUDY ...........................................................................................24 
4. 
OVERALL STUDY DESIGN .......................................................................................................................25 
5. 
STUDY POPULATION ................................................................................................................................26 
5.1 
INCLUSION CRITERIA ...............................................................................................................................26 
5.2 
EXCLUSION CRITERIA ..............................................................................................................................27 
5.3 
INCLUSION OF WOMEN AND MINORITIES .................................................................................................27 
6. 
STUDY DESIGN ...........................................................................................................................................28 
6.1 
STUDY FLOW DIAGRAM ...........................................................................................................................28 
6.2 
SCREENING AND ENROLLMENT ...............................................................................................................28 
6.3 
STUDY TREATMENT .................................................................................................................................28 
 
Treatment setting ............................................................................................................................................... 29 
6.3.1
 
Treatment regimen and study scheme ................................................................................................................ 29 
6.3.2
 
Study drug preparation ...................................................................................................................................... 29 
6.3.3
 
Study drug administration .................................................................................................................................. 30 
6.3.4
 
Pre and post-therapy intervention guidelines .................................................................................................... 31 
6.3.5
6.4 
DURATION OF PATIENT PARTICIPATION ..................................................................................................32 
6.5 
DOSE ESCALATION PHASE .......................................................................................................................32 
6.6 
EXPANSION PHASE ..................................................................................................................................34 
6.7 
STOPPING RULES .....................................................................................................................................35 
 
During dose escalation phase of the study ......................................................................................................... 35 
6.7.1
 
During expansion phase of the study ................................................................................................................. 35 
6.7.2
 
At any time during the study .............................................................................................................................. 35 
6.7.3
6.8 
PATIENT MONITORING, RESPONSE EVALUATION, TREATMENT CYCLE #3 AND #4, DISEASE PROGRESSION 
& SURVIVAL FOLLOW-UP .....................................................................................................................................36 
 
Patient monitoring ............................................................................................................................................. 36 
6.8.1

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 4 of 72 
 
 
Response evaluation ........................................................................................................................................... 36 
6.8.2
 
Treatment cycle #3 & #4 .................................................................................................................................... 36 
6.8.3
 
Disease progression and survival follow-up ...................................................................................................... 36 
6.8.4
6.9 
DOSE LIMITING TOXICITY ........................................................................................................................37 
 
Definition of dose limiting toxicity ..................................................................................................................... 37 
6.9.1
 
Definition of maximum tolerated dose (MTD) ................................................................................................... 37 
6.9.2
 
Definition of minimal efficacious dose (MED) .................................................................................................. 37 
6.9.3
6.10 
STUDY TREATMENT DISCONTINUATION ..................................................................................................37 
 
Study treatment discontinuation events ......................................................................................................... 37 
6.10.1
 
Replacement of participants .......................................................................................................................... 38 
6.10.2
 
Follow-ups after treatment discontinuation .................................................................................................. 39 
6.10.3
6.10.3.1. 
Discontinuation due to SAEs or on-going study drug related AEs .......................................................... 39 
6.10.3.2. 
Discontinuation due to any other reasons ................................................................................................. 39 
6.11 
STUDY TREATMENT INTERRUPTION ........................................................................................................39 
 
Kidney dysfunction ........................................................................................................................................ 39 
6.11.1
 
Hematological dysfunction ............................................................................................................................ 39 
6.11.2
 
Hypotension .................................................................................................................................................. 39 
6.11.3
 
Allergic reactions and cytokine release syndrome/acute infusion reaction .................................................. 40 
6.11.4
6.12 
GENERAL SUPPORTIVE CARE GUIDELINES AND DRUG INTERACTION ......................................................40 
 
Hypotension and capillary leak syndrome .................................................................................................... 40 
6.12.1
 
Pulmonary dysfunction .................................................................................................................................. 40 
6.12.2
 
Impaired kidney and liver functions .............................................................................................................. 41 
6.12.3
 
Infection ........................................................................................................................................................ 41 
6.12.4
 
Fever and chills ............................................................................................................................................. 41 
6.12.5
 
Gastritis ......................................................................................................................................................... 41 
6.12.6
 
Diarrhea, nausea and vomiting ..................................................................................................................... 41 
6.12.7
 
Pruritus and dermatitis ................................................................................................................................. 41 
6.12.8
 
Acidosis ......................................................................................................................................................... 41 
6.12.9
 
Life-threatening toxicities ............................................................................................................................. 41 
6.12.10
 
Other supportive care ................................................................................................................................... 41 
6.12.11
 
Drug interaction ............................................................................................................................................ 41 
6.12.12
7. 
STUDY DRUG: AVAILABILITY, ACCOUNTABILITY, PACKAGING & LABELING ...................43 
7.1 
AVAILABILITY .........................................................................................................................................43 
7.2 
ACCOUNTABILITY ...................................................................................................................................43 
7.3 
PACKAGING .............................................................................................................................................43 
7.4 
LABELING ................................................................................................................................................43 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS ................................................................44 
8.1 
STUDY CALENDAR ...................................................................................................................................44 
8.2 
PROCEDURE AND TESTS ..........................................................................................................................46 
 
Assays for immune cell levels and phenotype .................................................................................................... 46 
8.2.1
 
Medical history & prior therapy ........................................................................................................................ 46 
8.2.2
 
Pregnancy test .................................................................................................................................................... 46 
8.2.3
 
Physical examination ......................................................................................................................................... 46 
8.2.4
 
Vital signs, body weight & height ...................................................................................................................... 46 
8.2.5
 
Cardiac assessment ............................................................................................................................................ 46 
8.2.6
 
Pulmonary function monitoring ......................................................................................................................... 47 
8.2.7
 
Clinical blood tests ............................................................................................................................................ 47 
8.2.8
 
Disease assessment tests and procedures .......................................................................................................... 47 
8.2.9
 
Adverse event assessment .............................................................................................................................. 47 
8.2.10
 
Response assessment ..................................................................................................................................... 47 
8.2.11
 
Disease progression and survival follow-up ................................................................................................. 48 
8.2.12
 
Pharmacokinetic (PK) testing ....................................................................................................................... 48 
8.2.13
 
Biomarker assays for IL-2, IL-4, IL-6, IL-10, IFN-γ, MCP-1 and TNF-α .................................................... 48 
8.2.14
 
Immunogenicity tests - detection of anti-ALT-803 antibodies ....................................................................... 48 
8.2.15

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 5 of 72 
 
9. 
MEASUREMENT OF EFFECT ..................................................................................................................50 
9.1 
MEASURABLE DISEASE ............................................................................................................................50 
9.2 
EFFECT ASSESSMENT SCHEDULE .............................................................................................................50 
9.3 
METHODOLOGY OF RESPONSE EVALUATION ..........................................................................................50 
9.4 
RESPONSE EVALUATION CRITERIA ..........................................................................................................51 
9.5 
DISEASE PROGRESSION EVALUATION CRITERIA ......................................................................................52 
10. 
STATISTICAL ANALYSIS .....................................................................................................................53 
10.1 
STUDY OBJECTIVES .................................................................................................................................53 
10.2 
SAMPLE SIZE ............................................................................................................................................53 
10.3 
DATA COLLECTION ..................................................................................................................................53 
10.4 
DATA ANALYSIS ......................................................................................................................................53 
 
Analysis of safety ........................................................................................................................................... 54 
10.4.1
 
Analysis of response ...................................................................................................................................... 54 
10.4.2
 
Pharmacokinetics .......................................................................................................................................... 54 
10.4.3
11. 
REGULATORY AND REPORTING REQUIREMENTS ....................................................................55 
11.1 
ADVERSE EVENTS RECORDING, REPORTING AND COMMUNICATION .......................................................55 
11.2 
ADVERSE EVENT TERMINOLOGY AND DEFINITIONS ................................................................................55 
11.3 
ADVERSE EVENT REPORTING PROCEDURES ...........................................................................................56 
11.4 
ADVERSE EVENT EXPEDITED REPORTING GUIDELINES ..........................................................................57 
11.5 
SUBMISSION OF SERIOUS ADVERSE EVENT REPORTING ...........................................................................57 
11.6 
DATA REPORTING FORMS .......................................................................................................................57 
11.7 
REPORT /DATA SUBMISSION ADDRESS & CONTACT ................................................................................58 
11.8 
PATIENT RECORDS, QUALITY ASSURANCE, RECORDS RETENTION ..........................................................58 
11.9 
METHOD OF REVIEW ...............................................................................................................................58 
11.10 
SPECIAL REGULATORY CONSIDERATIONS ...........................................................................................59 
 
HIPAA ........................................................................................................................................................... 59 
11.10.1
 
Protocol amendments, informed consent, and IRB approval ........................................................................ 59 
11.10.2
12. 
CONFIDENTIALITY ...............................................................................................................................59 
13. 
ETHICAL STANDARDS & INVESTIGATOR OBLIGATIONS .......................................................59 
14. 
LIST OF EXPECTED ADVERSE EVENTS ..........................................................................................60 
15. 
CTCAE .......................................................................................................................................................62 
REFERENCES .......................................................................................................................................................63 
APPENDIX A: ECOG ...........................................................................................................................................65 
APPENDIX B: NEW YORK HEART ASSOCIATION CLASSIFICATION .................................................65 
APPENDIX C: ETHICAL STANDARDS ...........................................................................................................66 
APPENDIX D: INVESTIGATOR OBLIGATIONS ...........................................................................................67 
APPENDIX E: CONTACT LIST - ALTOR ........................................................................................................71 
APPENDIX F: CONTACT LIST – DATA SAFETY MONITORING BOARD (DSMB) ...............................72 
APPENDIX G: CONTACT LIST - LABORATORIES......................................................................................72 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 6 of 72 
SYNOPSIS 
Sponsor: 
Altor Bioscience Corporation 
Protocol#: 
CA-ALT-803-02-13 
Study Drug Name: Not applicable 
Study Treatment 
Active agents: 
ALT-803, a “recombinant human super agonist interleukin-15 (IL-15) complex” 
(AKA, IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
Study Type: 
Interventional 
Study Phase: 
I/II 
Protocol Title: 
A Study of ALT-803 in Patients with Relapsed or Refractory Multiple Myeloma 
Objectives: 
To evaluate the safety and tolerability of escalating doses, identify the Maximum 
Tolerated Dose level (MTD) or Minimum Efficacious Dose (MED) and designate 
a dose level for Phase II study (RP2D) of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
 
To evaluate the effect of ALT-803 on the peripheral absolute lymphocyte counts 
(ALC) and white blood cell (WBC) counts, the number and phenotype of 
peripheral blood T (total and subsets) and NK cells. 
To estimate the anti-tumor activity of ALT-803 by radiologic or pathologic disease 
response, progression free survival, and overall survival in treated patients.  
To characterize the immunogenicity and pharmacokinetic profile, including serum 
levels of IL-2, IL-4, IL-6, IL-10, IFN-γ, MCP-1 and TNF-α, of ALT-803 in treated 
patients. 
 
Study Design: 
This is a Phase I/II, open-label, multi-center, competitive enrollment, and dose-
escalation study of ALT-803 in patients with relapsed or refractory multiple 
myeloma. 
 
The study includes a dose escalation phase to determine the MTD or MED using a 
modified classic (3+3) dose escalation design and to designate a dose level for the 
Phase II expansion phase (RP2D) and a two-stage expansion phase at the RP2D 
using a Simon two-stage design. In Phase I, seven cohorts will be evaluated. A 
step-down dose level (cohort# -1) will be provided in the event of encountering 
DLT in two patients at the planned initial dose level. In the absence of 
unacceptable toxicity or disease progression, each enrolled patient will receive up 
to four 6-week study treatment cycles, each consisting of a 4-week treatment 
period and a 2-week rest period. In each cycle for cohort 1, 2, 3 and 4, patients will 
receive four doses of ALT-803 by intravenous (IV) injection weekly for 4 weeks 
followed by a 2-week rest period. In each cycle for cohort 5, 6and 7 patients will 
receive four doses of ALT-803 by subcutaneous (SubQ) injection weekly for 4 
weeks followed by a 2-week rest period. Patients with sufficient recovery of 
toxicities from the previous treatment cycles will be eligible to continue study 
treatment. After receiving two treatment cycles, patients who have at least stable 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 7 of 72 
disease assessed at week 11-12 may receive up to two additional study treatment 
cycles followed by reassessment for continued tumor response. 
The study will be conducted in conformity with Good Clinical Practice (GCP).  
 
Treatments:  
The study treatment plan for each enrolled patient includes up to four 6-week study 
treatment cycles. In each cycle for cohort 1, 2, 3 and 4 patients will receive four 
weekly doses of ALT-803 by intravenous injection followed by a 2-week rest 
period. In each cycle for cohort 5, 6 and 7 patients will receive four doses of ALT-
803 by subcutaneous injection weekly for 4 weeks followed by a 2-week rest 
period. The rest period may be extended to include up to four additional weeks if 
necessary. Patients who do not experience or who sufficiently recover from 
toxicities of the previous treatment cycles will be eligible to continue the treatment 
included in the study treatment plan. 
Treated patients will have up to two anti-tumor evaluation visits. Patients who 
receive at least three study drug doses during the first 2-cycle treatment period will 
be evaluated for anti-tumor response during week 11-12. Patients who have at least 
stable disease from the first anti-tumor evaluation and who meet other criteria to 
continue study treatment will receive up to two additional study treatment cycles, 
with the same treatment schedule, route of administration, and at the same dose 
level as the first two cycles; followed by reassessment for continued tumor 
response. 
The study treatment and response evaluation visits are illustrated below (refer to 
study calendar for all study visits): 
Treatment Cycle 
Cycle #1 
REST 
Cycle #2 
Response 
Evaluation 
Cycle #3 
REST 
Cycle #4 
Response 
Evaluation 
Treatment Week 
1 
2 
3 
4 
5-6 
7 
8 
9 10 
11-12 
13 14 15 16 
17-18 
19 
20 21 22 
23-24 
Treatment Day 
1 
8 
15 22 
23-42 
43 50 57 64 
71-84 
85 92 99 106 107-126 127 134 141 148 155-168 
Dose# 
1 
2 
3 
4 
Rest 
weeks 
5 
6 
7 
8 
 
9 10 11 12 
Rest 
weeks 
13 
14 15 16 
 
Response Evaluation 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
X 
ALT-803 
X 
X 
X 
X 
X 
X 
X 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
There are no restrictions on further therapies, such as chemotherapy, radiation 
therapy or surgery to be used after the protocol-specified therapy. Clearly, post-
study treatments could be of significant clinical benefit in selected patients, and 
these patients will be followed for outcome. 
Enrolled patients will receive the study treatment at qualified cancer treatment 
centers with adequate diagnostic and treatment facilities to provide appropriate 
management of therapy and complications. ALT-803 will be administered by 
intravenous infusion for cohort 1, 2, 3 and 4 into a central or peripheral vein under 
the supervision of a qualified physician experienced in the use of biologic anti-
cancer agents. ALT-803 will be administered by subcutaneous injection for cohort 
5, 6 and 7 under the supervision of a qualified physician experienced in the use of 
biologic anti-cancer agents. 
 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 8 of 72 
Dose Escalation 
Phase: 
A modified 3 + 3 design will be used for identifying a tolerable dose for phase II 
studies by monitoring patients for DLTs to determine the MTD and for identifying 
an efficacious dose by monitoring patients’ ALC and WBC count to determine the 
MED during the DLT observation period. The dose escalation phase is concluded 
when either the MTD or the MED is determined. A dose level (RP2D) will then be 
designated for Phase II study. There are seven cohorts of ALT-803 and a step-
down cohort (-1) with a lower dose level of ALT-803 in the event that unexpected 
toxicity is encountered at the initial dose level. 
 
Below are the planned dose levels and respective route of administration for the 
study drug during the dose escalation phase of the study.  
 
 
 
 
 
 
  
 
 
 
Dose limiting toxicity (DLT) is defined as follows: any toxicity that is not clearly 
unrelated to drug administration that is of Grade 3 and does not resolve to Grade 1 
or lower within a week despite the use of medical intervention or that is of Grade 
4, with exceptions described in the study protocol.  
The DLT Observation Period is defined as the duration of the first treatment cycle. 
 
Maximum Tolerated Dose level (MTD) is defined as a dose level at which <2 out 
of 6 patients experienced DLT and that is one level below a dose that was not 
tolerated. 
 
Minimal Efficacious Dose (MED) is defined as a dose level which produces an 
ALC ≥25,000/µL sustained for 14 days or a total WBC ≥35,000/µL sustained for 
14 days among 2/3 or 4/6 of patients. For safety, we have also defined an 
“exceeding MED” as the occurrence of ALC ≥35,000/µL or WBC ≥50,000/µL 
sustained for 14 days. 
 
Expansion 
Phase 
The two-stage expansion phase at the MTD or the MED level will be conducted 
using an optimal Simon’s two-stage design. Objective response (OR) (defined as 
complete response (CR) + partial response (PR)) will be evaluated and set 
Cohort 
ALT-803 Dose 
(µg/kg) 
Route 
Number of 
patients 
-1 
0.5 
IV 
3 to 6 
1 (initial) 
1 
IV 
3 to 6 
2 
3 
IV 
3 to 6 
3 
6 
IV 
3 to 6 
4 
10 
IV 
3 to 6 
5 
10 
SubQ 
3 to 6 
6 
15 
SubQ 
3 to 6 
7 
20 
SubQ 
3 to 6 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 9 of 72 
thresholds of lack of efficacy (OR rate (ORR) = 10%) and an efficacy level of 
interest (ORR = 30%) will be selected.  
Stopping Rules: 
Patient enrollment will be temporarily suspended based on occurrence of any of 
the following events, and the study committee, including the sponsor, the Data 
Safety Monitoring Board, and principal investigators will meet to discuss how to 
proceed with future patient enrollment in the study. 
During the dose escalation phase of the study,  
• If the maximum planned dose level has been reached, but neither the MTD nor 
MED can be determined. 
• If de-escalation occurs and the step-down dose level cannot be designated as 
the MTD or MED.  
Any time during the expansion phase of the study,  
• More than 33% of patients experience a possible, probable or definite study 
drug related DLT. 
• Favorable anti-tumor response data collected from enrolled patients. 
At any time during the study, 
The study committee may meet to discuss how to proceed with the study and may 
make any or all of the following recommendations for further patient enrollment:  
• Downward adjustment of the study drug dose. 
• Adjust the study drug dosing schedule. 
• Recommend more effective pre-therapy, intra-therapy, and post-therapy side 
effect mitigation interventions. 
• Correct protocol technical errors that caused unnecessary dose omissions or 
premature treatment discontinuations. After correction of protocol errors, the 
DSMB may meet to re-evaluate the safety profile of the study treatment and 
recommend how to proceed with the study, if necessary. 
Evaluations: 
Patients will be evaluated for clinical toxicities during the treatment. Patients’ 
blood samples will be collected to assess the pharmacokinetic profile and 
immunogenicity of the study drug. The anti-tumor response will be evaluated at 
week 11-12 and week 23-24 from the start of study treatment. All patients who 
receive at least 3 doses of the study drug ALT-803 will be included in the anti-
tumor response evaluation. 
Population: 
Patients of 18 years of age and above with relapsed or refractory multiple 
myeloma. Patients also need to have adequate cardiac, pulmonary, liver and 
kidney functions and have an Eastern Cooperative Oncology Group (ECOG) 
performance status of 0, 1 or 2.  
Sample Size: 
A total of up to 42 assessable patients will be accrued to the dose escalation phase of 
the study (Phase I). Anticipated enrollment to this phase is 24 patients. Up to an 
additional 23 assessable patients will be enrolled at the expansion phase (Stage 1 
and 2) of the study (Phase II). An estimated total of approximately 47 assessable 
patients will be enrolled to complete the study. Assuming a 20% rate of ineligible 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 10 of 72 
or non-assessable cases, an estimated total of up to 57 patients may be accrued to 
the study. 
 
Primary 
Endpoints 
For Phase I only 
(1) Determination of the MTD or MED and designation of the recommended dose 
level (RP2D) for Phase II study of ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
For Phase I & II 
(2) Safety profile of ALT-803 in treated patients. 
 
(3) Disease response rate of treated patients.  
Secondary  
Endpoints 
(1) Evaluation of the effect of ALT-803 on the peripheral ALC and WBC counts, 
the number and phenotype of peripheral blood T (total and subsets) and NK 
cells in treated patients. 
 
(2) Duration of response in treated patients. 
 
(3) Progression free survival of treated patients. 
(4) Overall survival of treated patients. 
(5) Characterization of the immunogenicity and pharmacokinetic profile, 
including serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ, MCP-1 and TNF-α, 
of ALT-803 in treated patients. 
Pharmacokinetics 
& Biomarkers: 
Fresh blood samples will be collected to assess immune cell levels and phenotype. 
Serum samples will be collected for pharmacokinetics and immunogenicity of the 
study drug ALT-803. The same serum samples collected for PK analysis will be 
used to assess the serum levels of IL-2, IL-4, IL-6, IL-10, IFN-γ, MCP-1, and 
TNF-α. Non-compartmental and compartmental PK analyses will be conducted. 
Bone marrow samples will be collected for future analysis of molecular markers 
associated with responses or resistance to ALT-803 in patients with relapsed or 
refractory multiple myeloma. 
Monitoring Tests: Blood samples for standard chemistry and CBC with differential will be obtained 
at screening, on each study treatment day, and at follow-up visits. Blood samples 
for immunogenicity testing for anti-ALT-803 antibodies will be collected prior to 
dosing on the first ALT-803 treatment day, at week 7 and at the first assessment 
during week 11-12 from the initial dose of study treatment. Blood and urine 
samples will be collected on each follow-up visit for response assessment.  
Response 
Assessment: 
There are at least two response assessments for treated patients: the first 
assessment during week 11-12 and the second assessment during week 23-24 from 
the start of study treatment. After completion of the first two cycles of study 
treatment, patients who have received at least 3 doses of study drug will have the 
first response assessment. After completion of the two additional cycles of study 
treatment, patients, regardless of the number of additional study drug doses 
received, will have the second response assessment. Response assessments will be 
carried out according to the new International Uniform Response Criteria for 

Altor BioScience Corp. 
 
 
 
CONFIDENTIAL 
                  CA-ALT-803-02-13 Version# 05 
IND 114006 SERIAL# 0008 
 
               
 
 
 
                          December 17, 2015 
Page 11 of 72 
Multiple Myeloma proposed by the International Myeloma Working Group. 
Baseline evaluations should be performed up to 28 days before study treatment 
starts.  
 
Progression & 
Survival 
Assessment: 
Progression-free survival, overall survival, and duration of response of all treated 
patients will be assessed every three months during year 1 and then every 6 
months during years 2 and 3 from the start of study treatment, or through the point 
designated as the end of the study follow up. 
Adverse Events: 
All patients will be monitored and evaluated for clinical toxicities during the 
treatment period and queried at each follow-up visit for Adverse Events (AEs). 
Patients may volunteer information concerning AEs. All adverse events will be 
graded by using the NCI Common Terminology Criteria for Adverse Events 
version 4.0 (CTCAE v4.0), and logged in the patient Case Report Form. The study 
centers should report all Serious Adverse Events (SAEs) and all events that trigger 
patient’s study treatment discontinuation to the sponsor via phone, fax or email (or 
a combination) no more than 24 hours after learning of the event. The sponsor will 
use the information to manage and coordinate the dose escalation, cohort 
expansion, and patient enrollment. The sponsor will then inform all of the 
participating clinical sites of the current dose level and the number of patients to 
be enrolled at that level, or of any patient enrollment suspension via phone, fax, or 
email within 24 hours of learning of the event. The study centers should report all 
other adverse events to the sponsor following the guidelines defined in the study 
protocol. All study drug related AEs that are both serious and unexpected will be 
reported to the FDA in an expedited manner in accordance with 21 CFR §312.32. 
Statistical Plan: 
For each cohort, all AEs will be tabulated and examined and all safety, 
pharmacokinetic and tumor response data will be evaluated. For estimation of 
duration of response and progression free survival, the Kaplan-Meier method will 
be used. P-values of ≤0.05 (two-sided) will be considered to indicate statistical 
significance.  
 
 

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 05 
IND 114006 SERIAL# 0008 
 
          
 
 
 
 
 
              
 
 
 
              December 17, 2015 
Page 44 of 72 
8. 
STUDY CALENDAR, CLINICAL PROCEDURES & TESTS 
8.1 
Study calendar 
1Screening/baseline evaluations are performed < 28 days prior to start of therapy.  If the patient's condition is deteriorating, ECOG status and laboratory evaluations should be repeated within 48 hours prior to dosing.  
2Pregnancy test is for women with childbearing potential only.  3Vital signs (especially blood pressure), clinical status and laboratory tests should be reviewed before start of therapy. Day 1 for the 1st patient of cohort 1, 2, 3 
and 4 will have vital signs evaluated at 15, 30, 60 and 120 min then hourly for 6 hours post infusion and every 3 hours thereafter until discharge (24 hrs). Vital signs for subsequent patients and dosing visits in cohort 1, 2, 3 and 
4 and for all dosing visits in cohort 5, 6 and 7, vital signs will be evaluated at 15, 30, 60 and 120 min and then hourly post treatment until discharge (or at completion of dose monitoring) from the clinic. Body weight will be 
collected before treatment on each treatment day for all patients. 4Patients who have an on-going study drug-related SAE upon study completion or at discontinuation of study will be contacted by the investigator or his/her 
designee every week until the event is resolved or determined to be irreversible. 5If the screening EKG was performed within 28 days prior to start of study treatment, the EKG is not required. 6Disease response and progression 
assessment will be evaluated using the new International Uniform Response Criteria for Multiple Myeloma proposed by the International Myeloma Working Group. 6.1Only when serum and urine M-protein are unmeasurable. 6.2 
Only when serum and urine M-protein and serum FLC are unmeasurable and bone marrow plasma cell percentage > 30% at baseline. 6.3Only when sCR is to be determined. 6.4Only when present at baseline, and to confirm CR 
or PR by X-rays, MRI or CT scans. 7Information about tumor assessment & other therapies received after completion of study treatment will be collected if available.  8Fresh blood samples for immune cell levels & phenotype 
testing will be collected before dosing. 9Collect blood samples at Time 0 (before treatment), at 30 min (+/- 5 min), 2 hour (+/- 15 min), 4 hour (+/- 30 min), 6 hour (+/- 60 min) , 24 hour (+/- 6 hour)- from Time 0.  IL-2, IL-4, 
TESTS & PROCEDURES 
SCREEN/ 
BASELINE1 
TREATMENT CYCLE #1 
 
REST  
TREATMENT 
CYCLE  #2 
1ST RESPONSE 
ASSESSMENT 
TREATMENT 
CYCLES     
#3 AND #4  
2ND RESPONSE 
ASSESSMENT 
FOLLOW-UPS 
Study Month  
 
1 
2 
2 - 3 
3 
4-5 
6 
9  12  18  24  30  36  
Study Week  
 
1 
2    
3 
4 
5-6 
7  
8 
9 
10 
11-12 
13-22 
23-24 
± 1 week 
Study Day  
 
1 
2 
3 
4 
8 
15 
22 
23 
25 
23-42 
 43 
50  
57  
 64 
71-84  
85-148 
155-168 
Tolerance Window 
 
+/- 2 days 
23-42 
+/- 2 days 
+/- 7 days 
 
+/- 7 days 
Medical history 
X 
 
 
 
 
 
 
 
 
 
R 
 
E 
 
S 
 
T 
 
 
P 
 
E 
 
R 
 
I 
 
O 
 
D 
 
 
 
 
 
Follow 
Institution’s 
standard of care 
(SOC) policy.  
If performed, 
follow the same 
schedule as in the 
first two cycles of 
study treatment. 
 
 
 
Serum pregnancy test2 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Complete physical exam 
X 
X 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
X 
Vital signs, Weight, Height3, Cardiac & Lung 
function monitoring  
X 
X 
 
 
 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
Concurrent medication 
X 
X 
 
 
 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
Adverse event assessment4 
X 
X  
 
 
 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
CBC with Differential12 
X 
X 
 
 
 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
Blood Chemistry12  
X 
X 
 
 
 
X 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
EKG 
X 
X5 
 
 
 
 
 
 
X 
 
 
 
 
 
PFT only when clinically indicated 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Response evaluation6 
  
  
 
X 
  
X 
 
Serum quantitative immunoglobulins 
X 
X 
X 
SPEP 
X  
X 
X 
UPEP-random  
X 
X 
X 
SIFE 
X 
X 
X 
UIFE -random 
X 
X 
X 
Serum FLC assay6.1 
X  
X 
X 
Bone marrow plasma cell percentage6.2 
X  
X 
X 
Bone marrow immunohistochemistry or 
immunofluorescence6.3 
 
X 
X 
Soft tissue plasmacytomas assessment6.4 
 
X 
X 
Disease & survival follow-up/post-therapies7 
 
  
 
 X  X 
X 
X 
X 
X 
Immune cell levels & phenotype8, 11 
 
X8 
X 
X13 
X 
 
 
X8 
X 
X 
X8 
 
 
X8 
 
 
 
 
PK, IL-2, IL-4, IL-6, IL-10, IFN-γ, MCP-1 TNF-
α9,11 
X9 
X 
X13 
X 
 
 
 
 
 
 
 
 
 
 
Immunogenicity tests10, 11 
 
X10 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
Study drug (ALT-803) 
 
a1 
 
 
 
a2 
a3 
a4 
 
 
a5 
a6 
a7 
a8 
 
Follow the same 
schedule as in the 
first 2 cycles  

Altor BioScience Corp. 
                                        CONFIDENTIAL               
 
 
    CA-ALT-803-02-13   Version# 05 
IND 114006 SERIAL# 0008 
 
          
 
 
 
 
 
              
 
 
 
              December 17, 2015 
Page 45 of 72 
IL-6, IL-10, IFN-γ, MCP-1 and TNF-α assays are performed using the same samples as PK.  10Use the sample collected before dosing for PK test. 11Residual samples may be used by Sponsor for research studies of other 
biomarkers. All attempts will be made to collect research samples but missed samples will not be considered a protocol deviation.  12Safety labs can be drawn within 72 hours of scheduled dose. 13The Cycle 1 Day 3 visit is 
optional if patient is available.