Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With ALT-803 (IL-15) in Patients With Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC)
Phase: PHASE2
Conditions: Stage IIIB Merkel Cell Carcinoma, Stage IV Merkel Cell Carcinoma
Sponsor: ImmunityBio, Inc.

CLINICAL TRIAL PROTOCOL 
______________________________________________________________________ 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 Protocol Date: October 3, 2014 
Protocol Version: 1 
Protocol Number: MCC-001 
Study Sponsor: 
Conkwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact: 
Karen Nichols 
Vice President, Regulatory and Quality 
KNichols@Conkwest.com 
Disclosure Statement:  This document contains information that is confidential and proprietary to 
Conkwest. This information is being provided to you solely for the purpose of evaluating and/or conducting 
a clinical trial for Conkwest.  You may disclose the contents of this protocol only to study personnel under 
your supervision, Independent Ethics Committee/Institutional Review Board or duly authorized 
representatives of regulatory agencies.  The foregoing shall not apply to disclosure required by any 
regulations; however, you will give prompt notice to Conkwest of any such disclosure. 

Conkwest, Inc.  
 
October 3, 2014 
Page 2 of 52 
 
TABLE OF CONTENTS 
 
 
1.0  INVESTIGATOR AGREEMENT .............................................................................. 4 
2.0   LIST OF ABBREVIATIONS ..................................................................................... 5 
3.0   STUDY SYNOPSIS ................................................................................................. 6 
4.0   BACKGROUND AND STUDY RATIONALE .......................................................... 11 
4.1    Merkel Cell Carcinoma ..................................................................................................... 11 
4.2    Advances in Understanding the Immuno-Biology of MCC ................................................ 12 
4.3    The Role of the Immune System in MCC and Emerging Therapies ................................. 14 
4.4    NK Cells and Their Therapeutic Use ................................................................................ 15 
4.5 
Role of NK cells in Merkel Cell Cancer ............................................................................. 16 
4.6 
NK-92 Cells ....................................................................................................................... 16 
4.7 
Animal Studies with NK-92 Cells ...................................................................................... 17 
4.8 
Safety of NK-92 Cells ........................................................................................................ 19 
4.9 
Ex Vivo Expansion of NK-92 Cells .................................................................................... 20 
4.10 Human Trials with NK-92 Cells ....................................................................................... 20 
4.11  Rationale for Clinical Trial in Merkel Cell Cancer ........................................................... 21 
5.0   STUDY OBJECTIVES ........................................................................................... 22 
5.1    Primary Objective ............................................................................................................. 22 
5.2 
Secondary Objectives ....................................................................................................... 22 
6.0  STUDY DESIGN .................................................................................................... 23 
6.1  
Overview of Clinical Trial Design ..................................................................................... 23 
7.0   SELECTION OF STUDY POPULATION ............................................................... 23 
7.1      Inclusion Criteria: ............................................................................................................ 23 
7.2      Exclusion Criteria: ........................................................................................................... 23 
7.3   Screen Failures ............................................................................................................... 25 
8.0  TREATMENT OF PATIENTS ................................................................................ 25 
8.1   Study Visits ..................................................................................................................... 25 
8.1.1  Screening Visit ............................................................................................................... 25 
8.1.2 NeukoplastTM Infusion Cycle 1: ...................................................................................... 26 
8.1.3 NeukoplastTM Infusion Cycle 2: ...................................................................................... 27 
8.1.4 Pre-Infusion Assessment Visits for Cycles 3-6: ............................................................. 27 
8.1.5 NeukoplastTM Infusion Cycles 3-6: ................................................................................. 27 
8.1.6   6-Month Follow-up Visit .................................................................................................. 28 
8.1.7   Long Term Follow-up ...................................................................................................... 28 
8.2 
Concomitant Medications .................................................................................................. 28 
8.3 
Disease Progression Assessments .................................................................................. 28 
8.4 
Response Evaluation Criteria in Solid Tumors (RECIST) ................................................. 29 
8.4.1 Evaluation of Target Lesions ......................................................................................... 29 
8.4.2 Evaluation of Non-target Lesions ................................................................................... 30 
8.4.3 Evaluation of Best Overall Response ............................................................................ 30 
8.5  
Eastern Cooperative Oncology Group (ECOG) Performance Status .............................. 31 
8.6     Histological MCC Confirmation ........................................................................................ 31 
8.7     Clinical Laboratory Testing .............................................................................................. 31 
8.8     Immunologic Studies ....................................................................................................... 32 
8.8.1 Evaluate the Development of Anti-HLA Antibodies ........................................................ 32 
8.9 
Quality of Life Questionnaire (QOL) .................................................................................. 32 
8.10  Off-Study Criteria .............................................................................................................. 32 

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October 3, 2014 
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9.0   INVESTIGATIONAL PRODUCT ............................................................................ 32 
9.1   Neukoplast™ Preparation and Administration ................................................................ 32 
9.2   Investigational Product Accountability ............................................................................ 33 
10.0  SAFETY ASSESSMENTS ..................................................................................... 33 
10.1   Adverse Events ................................................................................................................ 33 
10.1.1    Definitions .................................................................................................................... 33 
10.1.2   Reporting ..................................................................................................................... 34 
10.1.3   Expectedness .............................................................................................................. 35 
10.1.4   Attribution ..................................................................................................................... 35 
10.1.5   Grade ........................................................................................................................... 36 
10.2 Toxicity Stopping Rules .................................................................................................. 36 
10.3 Planned Enrollment Delay .............................................................................................. 37 
10.4 Protocol Safety Committee ............................................................................................. 37 
11.0    DATA QUALITY ASSURANCE ........................................................................... 37 
12.0    STATISTICAL ANALYSIS ................................................................................... 38 
12.1   Primary Objective ........................................................................................................... 38 
12.2     Secondary Objectives .................................................................................................... 38 
12.3  Determination of Sample Size ....................................................................................... 38 
12.4  Statistical and Analytical Plans ...................................................................................... 39 
12.5  Analysis of Primary Endpoints ....................................................................................... 39 
12.6  Analysis of Secondary Endpoints .................................................................................. 40 
12.7  Toxicity Endpoint ............................................................................................................ 41 
12.8  Interim Analysis .............................................................................................................. 41 
13.0  INVESTIGATOR REGULATORY OBLIGATIONS ................................................. 42 
13.1  EC/IRB Approval ............................................................................................................ 42 
13.2  Pre-study Documentation .............................................................................................. 42 
13.3  Informed Consent .......................................................................................................... 43 
13.4  Protocol Adherence ....................................................................................................... 43 
13.5  Permission to Review Patients’ Source Records ........................................................... 43 
13.6  Protocol Amendments .................................................................................................... 43 
13.7  Change in Investigator ................................................................................................... 44 
13.8  Retention of Study Documents ...................................................................................... 44 
14.0  REFERENCES ...................................................................................................... 45 
 
 
 
Appendix A – Schedule of Events 
Appendix B – Functional Assessment of Cancer Therapy – General (Version 4) 

Conkwest, Inc.  
 
October 3, 2014 
Page 4 of 52 
 
 
 
     1.0  
INVESTIGATOR AGREEMENT 
 
I have read the attached Protocol entitled “Phase II Study of NeukoplastTM (NK-92) Infusions in 
Patients with Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma 
(MCC)” dated October 3, 2014.  I agree to abide by all provisions set forth herein.  I agree to 
comply with the International Conference on Harmonization Tripartite Guidelines on Good Clinical 
Practice, effective in the United States from 9 May 1997, and applicable United States Food and 
Drug Administration regulations set forth in 21 CFR §50, 54, 56, and 312.  I agree to ensure that 
the confidential information contained in this document will not be used for any purpose other than 
the evaluation and conduct of the clinical investigation without the prior written consent of 
Conkwest, Inc. 
 
 
 
 
____________________________________                              _____________ 
Signature of Investigator                                                               Date 
 
 
____________________________________ 
Printed Name of Investigator 
 
 
__________________________________________________ 
Address of Investigator 
 
 
____________________________________ 
Phone Number of Investigator 

Conkwest, Inc.  
 
October 3, 2014 
Page 5 of 52 
 
2.0   
LIST OF ABBREVIATIONS  
 
AE 
Adverse Event/Experience 
ALT 
Alanine transaminase 
AST 
Aspartate transaminase 
BUN 
Blood urea nitrogen 
CAR 
Chimeric antigen receptors 
CBC 
Complete blood count 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case report form 
CRO 
Contract research organization 
CT 
Computed tomography 
CTC 
Common toxicity criteria 
EBV 
Epstein-Barr virus 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
EC 
Ethics Committee 
GCP 
HIV 
Good Clinical Practice 
Human immunodeficiency virus 
IND 
Investigational New Drug 
IRB 
Institutional Review Board 
IV 
Intravenous 
LDL 
Low-density lipoprotein 
MCC 
Merkel Cell Carcinoma 
MCV 
Merkel cell polyomavirus 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mm 
millimeter 
MRI 
Magnetic resonance imaging 
NCI 
National Cancer Institute 
NK 
Natural Killer 
OS 
Overall Survival 
PFS 
Progression free survival 
QOL 
Quality of Life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious adverse event 
SCID 
Severe combined immunodeficiency 
SOP 
Standard operating procedure 
TIL 
Tumor infiltrating lymphocytes 
WBC 
White blood cell 
 
 
 
 
 
 

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October 3, 2014 
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3.0   
STUDY SYNOPSIS 
Title of Study: 
 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 
Objectives: 
 
Primary Objective: 
a) Determine the effect of NeukoplastTM infusions on the 6-month (~24 
weeks) progression-free survival (PFS) rate in patients with unresectable 
stage III (IIIB) or distant metastatic (stage IV) MCC based on Response 
Evaluation Criteria in Solid Tumors (RECIST) (v1.1). 
Secondary Objectives: 
a) Determine the overall response rate, as assessed by RECIST at week 24 
b) Time to disease progression 
c) Median overall survival 
d) Assess the safety and toxicity of NeukoplastTM 
e) Quality of life assessment (FACT-G) 
 
Study Design: 
 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect 
of NeukoplastTM infusions in patients with unresectable stage III (IIIB) or distant 
metastatic (stage IV) MCC.  The study will use an adaptive Simon optimal two-stage 
design.  This two-stage design detects efficacy signals, allows for early assessment and 
avoids enrolling larger numbers of patients in case of inefficacy.  In the first stage, 13 
patients unresectable stage III (IIIB) or distant metastatic (stage IV) MCC will be 
screened in order to end up with 12 enrolled and treated. If the treatment combination 
can improve the 6-month progression free survival (PFS) rate from 4% to 20% [e.g. at 
least 1 patient out of 12 patients has PFS ≥ 24 weeks (6 months)], then the study will 
proceed to the second stage, in which 13 more patients will be screened in order to end 
up with 12 eligible who will be enrolled and treated.  In addition, there will be a planned 
enrollment pause after the first 6 patients are enrolled, in order to assess the safety of 
NeukoplastTM infusions.  Once the 6h patient completes the first two infusion cycles 
without any serious treatment related Adverse Events, enrollment may resume (see 
section 10.3).  NeukoplastTM will be given via IV infusion at a dose of 2 x 109 cells/m2 on 
two consecutive days (= 1 cycle) every 4 weeks for a total of 6 cycles (12 infusions). If 

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October 3, 2014 
Page 7 of 52 
 
there is evidence of disease progression, at any time point after the second cycle, the 
patient will be withdrawn from the trial.   
 
Number of Patients: 
 
Approximately 24 treated 
 
Duration of Treatment: 
 
The total duration of planned treatment is 5 months. 
 
Inclusion Criteria: 
 
1. Male or female patients 18 years of age or older.  
2. Patients must have histologically confirmed inoperable Stage III (IIIB) or Stage IV 
MCC, as defined by the 2010 AJCC staging criteria for MCC(2). Patients with 
stage IIIB MCC must have been evaluated by a surgical oncologist who has 
attested that their disease is surgically unresectable.  MCC of unknown primary 
is allowed. 
3. Up to two prior cytotoxic chemotherapies for MCC are allowed. 
4. ECOG performance status of 0-2. 
5. Voluntary written informed consent must be given before performance of any 
study-related procedure not part of normal medical care, with the understanding 
that consent may be withdrawn by the patient at any time without prejudice to 
future medical care.  
 
Exclusion Criteria: 
 
1.  Major surgery within 30 days before study entry. 
2.  Any of the following clinical laboratory values within 21 days prior to enrollment: 
a. Absolute neutrophil count (ANC)  < 1,000 cells/mm3, 
b. Platelets < 50,000 x 109/L, 
c. Aspartate aminotransferase or alanine aminotransferase > 2 x the ULN, on 
condition that these abnormalities are associated with hepatic involvement by 
the tumor and not due to other hepatic diseases, 
d. Any abnormality of serum creatinine. 
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation 
(e.g. AST, ALT, gGT) > 2 times the normal range. Elevation related to direct tumor 

Conkwest, Inc.  
 
October 3, 2014 
Page 8 of 52 
 
infiltration is allowed. 
4. Renal insufficiency as indicated by a creatinine level > 2 mg/dl.  
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital 
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe 
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or 
significant conduction system abnormalities in the opinion of the investigator.  
Prior to study entry any known abnormality on electrocardiogram (ECG) must be 
determined and documented by the investigator to be not clinically relevant to the 
patient participation in this study. 
6.  Any condition, including laboratory abnormalities, that in the opinion of the 
investigator places the patient at unacceptable risk if he/she were to participate in 
the study.  This includes, but is not limited, to serious medical conditions or 
psychiatric illness likely to interfere with participation in this clinical study. 
7. Female patients who are pregnant or breastfeeding. Female patients of 
childbearing potential must have a negative pregnancy test and agree to use 
adequate contraception for the duration of the trial. 
8. Patients with other malignancies are not eligible. However, given the frequent 
coexistence of MCC with other malignancies, the following exceptions are 
allowed:  
a) If they have been continuously disease-free for any solid tumor malignancy 
>3 years prior to the time of randomization,  
b) Patients with basal cell carcinoma or squamous cell carcinoma  
c) Patients with prior history of in situ cancer (e.g. breast, melanoma, cervical),  
d) Patients with prior history of prostate that is not under active systemic 
treatment except hormonal therapy, but with undetectable PSA (<0.2ng/mL),  
e) Patients with chronic lymphocytic leukemia are eligible if they have isolated 
lymphocytosis (Rai stage O) on condition that they do not require systemic 
treatment for their disease [“B” symptoms, Richter’s transformation, 
lymphocyte 
doubling 
time 
(<6 
months) 
and 
they 
do 
not 
have 
lymphadenopathy of hepatosplenomegaly]. 
f) Patients with lymphoma of any type or hairy cell leukemia are eligible on 
condition that they do not receive active systemic treatment for their 
hematologic disease and are in complete remission as evidenced by 
PET/CT scans and bone marrow biopsies for at least 3 months. 

Conkwest, Inc.  
 
October 3, 2014 
Page 9 of 52 
 
Investigational Product and Administration: 
 
Neukoplast™ (from Conkwest, Inc.) will be provided for clinical administration from a 
GMP contract manufacturer (CMO).   The production/expansion (in vitro) of 
Neukoplast™ will be according to the standard operating procedures on file at GMP cell 
processing facility in accordance with CMO procedures and in accordance with 
information contained in BB-IND 8404 entitled “Natural Killer Cell Line, Neukoplast™ 
(NK-92), Expanded with Interleukin-2 Novartis)”; IND Sponsor: Conkwest, Inc. Cells will 
be shipped from the CMO to the study site according to validated procedures detailed in 
the IND.    Cells will be washed and concentrated at the clinical site. In order to prevent 
Neukoplast™ cell proliferation, the Neukoplast™ cells will be irradiated with 1000 cGy 
prior to infusion at the study site. The cells for the second day infusion will be kept 
overnight in the Cell Processing facility under controlled conditions and at room 
temperature.   
 
Efficacy Evaluation: 
 
The 6-month PFS rate will be calculated as the number of patients alive and progression 
free (based on RECIST v1.1) at six months from the date of 1st infusion divided by the 
total number of patients.  For purposes of this analysis, the 6-month PFS rate will be 
calculated with 6 months being based on greater than or equal to 168 days (e.g., 
patients alive and progression-free for at least 168 days will be counted in the numerator 
of the PFS rate calculation).   
 
Safety Evaluation: 
 
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, 
changes on physical exams, and laboratory values.  All clinically significant findings on 
any post-baseline tests will be reported as AEs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities.   Treatment-emergent AEs will be defined as 
those events with start dates on or after the date of the first infusion or events that were 
present prior to the start of treatment but worsened in severity following the first infusion. 
   
Toxicity Stopping Rule: 
 
To avoid exposure of patients to unnecessary toxicity, continuous toxicity monitoring will 
be performed throughout the study. The trial will be stopped for toxicity if the death rate 

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October 3, 2014 
Page 10 of 52 
 
attributed to therapy (and not to the natural history of disease) significantly exceeds 5% 
during the first 12 weeks of treatment. Specifically, using a Pocock type stopping 
boundary which assumes that the death rate attributed to therapy of 0.05 is the 
maximum acceptable rate, the trial will be stopped if ≥2 deaths are observed in the first 6 
patients or ≥3 deaths are observed in the first 9 patients.  If ≥4 deaths are observed in 
the first cohort of 12 patients, enrollment into the second cohort will be halted.  If none of 
the toxicity stopping rules are met, enrollment into the next cohort may be initiated.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                      
 
 
 

Conkwest, Inc. 
October 3, 2014 
Page 50 of 52 
Appendix A – Schedule of Events 
Study Period 
Screening 
NeukoplastTM Treatment 
6-Month
Follow-up 
Visit 
Study Visits 
Visit 1 
Visit 2 
Cycle 1 
Visit 3 
Cycle 2 
Pre-Treatment 
Assessment 
Visit 4, 6, 8, 10 
Visit 5, 7, 9, 11 
Cycles 3-6 
Visit 12 
Visit Timeframe / 
Window 
- 21 days
 Day 0 
(+/- 7 days) 
Week 4 
(+/- 7 days) 
(+/- 3 days) 
 Weeks 8,12, 
16, and 20 
(+/- 7 days) 
24 weeks 
Informed Consent 
X 
Eligibility Criteria 
X 
Medical History 
X 
Physical Exam 
X 
X 
X 
Vitals
X 
X1 
X1
X
X1 
X 
Height and Weight 
X 
X 
CT/MRI 
X 
X 
12-lead ECG
X 
X 
X 
ECOG 
X 
X 
X 
QOL 
Questionnaire 
X 
X 
X 
Pregnancy Test 
X 
X 
X 
Chemistries / 
Hematology
X
X 
X 
Anti-HLA 
Antibodies2
X2
X2 
Urinalysis 
X 
X 
X 
Concomitant 
Medications 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
NeukoplastTM 
Infusion 
X 
X 
X 
Disease 
Progression 4
X 
X 
Survival Status 3 
X 
1 - Vital signs will be recorded at 0, 15(+/- 3 minutes), 30(+/- 3 minutes), 60(+/- 5 minutes), 90(+/- 5 minutes) and 
120(+/- 5 minutes) post-infusion. 
2 - The development of anti-HLA antibodies will be evaluated prior to Cycle 2 and at 6 months. 
3 - Patient will be followed for survival status until death or lost to follow-up. 
4 - These assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, 
or radiographic imaging (x-ray, computed tomography [CT] scan, positron emission tomography [PET] scan, 
magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging method should be used 
consistently throughout the study to avoid variability in results. 

CLINICAL TRIAL PROTOCOL 
______________________________________________________________________ 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 Protocol Date: November 1, 2014 
Amendment 1 
Protocol Version: 2 
Protocol Number: MCC-001 
Study Sponsor: 
Conkwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact: 
Karen Nichols 
Vice President, Regulatory and Quality 
KNichols@Conkwest.com 
Disclosure Statement:  This document contains information that is confidential and proprietary to 
Conkwest. This information is being provided to you solely for the purpose of evaluating and/or conducting 
a clinical trial for Conkwest.  You may disclose the contents of this protocol only to study personnel under 
your supervision, Independent Ethics Committee/Institutional Review Board or duly authorized 
representatives of regulatory agencies.  The foregoing shall not apply to disclosure required by any 
regulations; however, you will give prompt notice to Conkwest of any such disclosure. 

Conkwest, Inc.  
 
November 1, 2014 
Page 4 of 53 
 
 
 
     1.0  
INVESTIGATOR AGREEMENT 
 
I have read the attached Protocol entitled “Phase II Study of NeukoplastTM (NK-92) Infusions in 
Patients with Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma 
(MCC)” dated November 1, 2014.  I agree to abide by all provisions set forth herein.  I agree to 
comply with the International Conference on Harmonization Tripartite Guidelines on Good Clinical 
Practice, effective in the United States from 9 May 1997, and applicable United States Food and 
Drug Administration regulations set forth in 21 CFR §50, 54, 56, and 312.  I agree to ensure that 
the confidential information contained in this document will not be used for any purpose other than 
the evaluation and conduct of the clinical investigation without the prior written consent of 
Conkwest, Inc. 
 
 
 
 
____________________________________                              _____________ 
Signature of Investigator                                                               Date 
 
 
____________________________________ 
Printed Name of Investigator 
 
 
__________________________________________________ 
Address of Investigator 
 
 
____________________________________ 
Phone Number of Investigator 

Conkwest, Inc.  
 
November 1, 2014 
Page 6 of 53 
 
3.0   
STUDY SYNOPSIS 
Title of Study: 
 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 
Objectives: 
 
Primary Objective: 
a) Determine the effect of NeukoplastTM infusions on the 4-month (~16 
weeks) progression-free survival (PFS) rate in patients with unresectable 
stage III (IIIB) or distant metastatic (stage IV) MCC based on Response 
Evaluation Criteria in Solid Tumors (RECIST) (v1.1). 
Secondary Objectives: 
a) Determine the overall response rate, as assessed by RECIST at week 16 
b) Time to disease progression 
c) Median overall survival 
d) Assess the safety and toxicity of NeukoplastTM 
e) Quality of life assessment (FACT-G) 
 
Study Design: 
 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect 
of NeukoplastTM infusions in patients with unresectable stage III (IIIB) or distant 
metastatic (stage IV) MCC.  The study will use an adaptive Simon optimal two-stage 
design.  This two-stage design detects efficacy signals, allows for early assessment and 
avoids enrolling larger numbers of patients in case of inefficacy.  In the first stage, 13 
patients unresectable stage III (IIIB) or distant metastatic (stage IV) MCC will be 
screened in order to end up with 12 enrolled and treated. If the treatment combination 
can improve the 4-month progression free survival (PFS) rate from 4% to 20% [e.g. at 
least 1 patient out of 12 patients has PFS ≥ 16 weeks (4 months)], then the study will 
proceed to the second stage, in which 13 more patients will be screened in order to end 
up with 12 eligible who will be enrolled and treated.  In addition, there will be a planned 
enrollment pause after the first 6 patients are enrolled, in order to assess the safety of 
NeukoplastTM infusions.  Once the 6h patient completes the first two infusion cycles 
without any serious treatment related Adverse Events, enrollment may resume (see 
section 10.3).  NeukoplastTM will be given via IV infusion at a dose of 2 x 109 cells/m2 on 
two consecutive days (= 1 cycle) every 4 weeks for a total of 4 cycles (8 infusions). If 

Conkwest, Inc.  
 
November 1, 2014 
Page 7 of 53 
 
there is evidence of disease progression believed to be unrelated to an inflammatory 
immune mediated response, at any time point after the second cycle, the patient will be 
withdrawn from the trial.   
 
Number of Patients: 
 
Approximately 24 treated in two cohorts of 12 patients. 
 
Duration of Treatment: 
 
The total duration of planned treatment is 4 months. 
 
Inclusion Criteria: 
 
1. Male or female patients 18 years of age or older.  
2. Patients must have histologically confirmed inoperable Stage III (IIIB) or Stage IV 
MCC, as defined by the 2010 AJCC staging criteria for MCC(2). Patients with 
stage IIIB MCC must have been evaluated by a surgical oncologist who has 
attested that their disease is surgically unresectable.  MCC of unknown primary 
is allowed. 
3. Up to two prior cytotoxic chemotherapies and/or novel immunotherapy 
treatments for MCC are allowed. 
4. ECOG performance status of 0-2. 
5. Voluntary written informed consent must be given before performance of any 
study-related procedure not part of normal medical care, with the understanding 
that consent may be withdrawn by the patient at any time without prejudice to 
future medical care.  
 
Exclusion Criteria: 
 
1.  Major surgery within 30 days before study entry. 
2.  Any of the following clinical laboratory values at the time of enrollment: 
a. Absolute neutrophil count (ANC)  < 1,000 cells/mm3, 
b. Platelets < 50,000 x 109/L, 
c. Serum creatinine > 2 x the ULN 
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation 
(e.g. AST, ALT, gGT) > 2 times the normal range. Elevation related to direct tumor 
infiltration is allowed. 

Conkwest, Inc.  
 
November 1, 2014 
Page 8 of 53 
 
4. Renal insufficiency as indicated by a creatinine level > 2 x the ULN.  
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital 
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe 
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or 
significant conduction system abnormalities in the opinion of the investigator.  
Prior to study entry any known abnormality on electrocardiogram (ECG) must be 
determined and documented by the investigator to be not clinically relevant to the 
patient participation in this study. 
6.  Any condition, including laboratory abnormalities, that in the opinion of the 
investigator places the patient at unacceptable risk if he/she were to participate in 
the study.  This includes, but is not limited, to serious medical conditions or 
psychiatric illness likely to interfere with participation in this clinical study. 
7. Female patients who are pregnant or breastfeeding. Female patients of 
childbearing potential must have a negative pregnancy test and agree to use 
adequate contraception for the duration of the trial. 
8. Patients with other malignancies are not eligible. However, given the frequent 
coexistence of MCC with other malignancies, the following exceptions are 
allowed:  
a) If they have been continuously disease-free for any solid tumor malignancy 
>3 years prior to the time of enrollment.  
b) Patients with basal cell carcinoma or squamous cell carcinoma  
c) Patients with prior history of in situ cancer (e.g. breast, melanoma, 
squamous cells carcinoma of the skin, cervical),  
d) Patients with prior history of prostate that is not under active systemic 
treatment except hormonal therapy, but with undetectable PSA (<0.2ng/mL),  
e) Patients with chronic lymphocytic leukemia are eligible if they have isolated 
lymphocytosis (Rai stage O) on condition that they do not require systemic 
treatment for their disease [“B” symptoms, Richter’s transformation, 
lymphocyte 
doubling 
time 
(<6 
months) 
and 
they 
do 
not 
have 
lymphadenopathy of hepatosplenomegaly]. 
f) Patients with lymphoma of any type or hairy cell leukemia are eligible on 
condition that they do not receive active systemic treatment for their 
hematologic disease and are in complete remission as evidenced by 
PET/CT scans and bone marrow biopsies for at least 3 months. 

Conkwest, Inc.  
 
November 1, 2014 
Page 9 of 53 
 
Investigational Product and Administration: 
 
Neukoplast™ (from Conkwest, Inc.) will be provided for clinical administration from a 
GMP contract manufacturer (CMO).  The production/expansion (in vitro) of Neukoplast™ 
will be according to the standard operating procedures on file at GMP cell processing 
facility in accordance with CMO procedures and in accordance with information 
contained in BB-IND 8404 entitled “Natural Killer Cell Line, Neukoplast™ (NK-92), 
Expanded with Interleukin-2 Novartis)”; IND Sponsor: Conkwest, Inc. Cells will be 
shipped from the CMO to the study site according to validated procedures detailed in the 
IND.    Cells will be washed and concentrated at the clinical site. In order to prevent 
Neukoplast™ cell proliferation, the Neukoplast™ cells will be irradiated with 1000 cGy 
prior to infusion at the study site. The cells for the second day infusion will be kept 
overnight in the Cell Processing facility under controlled conditions and at room 
temperature.   
 
Efficacy Evaluation: 
 
The 4-month PFS rate will be calculated as the number of patients alive and progression 
free (based on RECIST v1.1) at four months from the date of 1st infusion divided by the 
total number of patients.  For purposes of this analysis, the 4-month PFS rate will be 
calculated with 4 months being based on greater than or equal to 112 days (e.g., 
patients alive and progression-free for at least 112 days will be counted in the numerator 
of the PFS rate calculation).   
 
Safety Evaluation: 
 
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, 
changes on physical exams, and laboratory values.  All clinically significant findings on 
any post-baseline tests will be reported as AEs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities.   Treatment-emergent AEs will be defined as 
those events with start dates on or after the date of the first infusion or events that were 
present prior to the start of treatment but worsened in severity following the first infusion. 
   
Toxicity Stopping Rule: 
 
To avoid exposure of patients to unnecessary toxicity, continuous toxicity monitoring will 
be performed throughout the study. The trial will be stopped for toxicity if the death rate 

Conkwest, Inc.  
 
November 1, 2014 
Page 10 of 53 
 
attributed to therapy (and not to the natural history of disease) significantly exceeds 5% 
during the first 12 weeks of treatment. Specifically, using a Pocock type stopping 
boundary which assumes that the death rate attributed to therapy of 0.05 is the 
maximum acceptable rate, the trial will be stopped if ≥2 deaths are observed in the first 6 
patients or ≥3 deaths are observed in the first 9 patients.  If ≥4 deaths are observed in 
the first cohort of 12 patients, enrollment into the second cohort will be halted.  If none of 
the toxicity stopping rules are met, enrollment into the next cohort may be initiated.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Conkwest, Inc.  
 
November 1, 2014 
Page 51 of 53 
 
 
Appendix A – Schedule of Events 
 
Study Period 
Screening 
NeukoplastTM Treatment 
 
4-Month 
Follow-up 
Visit 
Study Visits 
Visit 1 
Visit 2 
Cycle 1 
Visit 3 
Cycle 2 
Pre-Treatment 
Assessment 
Visit 4, 6 
Visit 5, 7 
Cycles 3 & 4 
 
Visit 8 
Visit Timeframe / 
Window 
- 21 days 
 Day 0    
(+/- 7 days) 
Week 4     
(+/- 7 days) 
Within 2 weeks 
of next cycle 
 Weeks 8 &12 
(+/- 7 days) 
16 weeks 
Informed Consent 
X 
 
 
 
 
 
Eligibility Criteria 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
 
X 
Vitals 
X 
X1 
X1 
X 
X1 
X 
Height and Weight 
X 
 
 
 
 
X 
CT/MRI 
X 
 
 
 
 
X 
12-lead ECG 
X 
 
 
X 
 
X 
ECOG  
X 
 
 
X 
 
X 
QOL 
Questionnaire 
X 
 
 
X 
 
X 
Pregnancy Test 
X 
 
 
X 
 
X 
Chemistries / 
Hematology 
X 
 
 
X 
 
X 
Anti-HLA 
Antibodies2 
 
 
X2 
 
 
X2 
Urinalysis 
X 
 
 
X 
 
X 
Concomitant 
Medications 
X 
 
 
X 
 
X 
Adverse Events 
 
 
X 
X 
X 
X 
NeukoplastTM 
Infusion 
 
X 
X 
 
X 
 
Disease 
Progression 4 
 
 
 
X 
 
X 
Survival Status 3 
 
 
 
 
 
X 
 
1 - Vital signs will be recorded at 0, 15(+/- 3 minutes), 30(+/- 3 minutes), 60(+/- 5 minutes), 90(+/- 5 minutes) and 
120(+/- 5 minutes) post-infusion. 
2 - The development of anti-HLA antibodies will be evaluated prior to Cycle 2 and at 4 months. 
3 - Patient will be followed for survival status until death or lost to follow-up. 
4 - These assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, 
or radiographic imaging (x-ray, computed tomography [CT] scan, positron emission tomography [PET] scan, 
magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging method should be used 
consistently throughout the study to avoid variability in results. 
 
 

CLINICAL TRIAL PROTOCOL 
______________________________________________________________________ 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 Protocol Date: April 1, 2015 
Amendment 2 
Protocol Version: 3 
Protocol Number: MCC-001 
Study Sponsor: 
Conkwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact: 
Karen Nichols 
Vice President, Regulatory and Quality 
KNichols@Conkwest.com 
Disclosure Statement:  This document contains information that is confidential and proprietary to 
Conkwest. This information is being provided to you solely for the purpose of evaluating and/or conducting 
a clinical trial for Conkwest.  You may disclose the contents of this protocol only to study personnel under 
your supervision, Independent Ethics Committee/Institutional Review Board or duly authorized 
representatives of regulatory agencies.  The foregoing shall not apply to disclosure required by any 
regulations; however, you will give prompt notice to Conkwest of any such disclosure. 

Conkwest, Inc.  
 
April 1, 2015 
Page 2 of 54 
 
TABLE OF CONTENTS 
 
1.0  INVESTIGATOR AGREEMENT .............................................................................. 4 
2.0   LIST OF ABBREVIATIONS .................................................................................... 5 
3.0   STUDY SYNOPSIS ................................................................................................. 6 
4.0   BACKGROUND AND STUDY RATIONALE ......................................................... 11 
4.1     Merkel Cell Carcinoma .................................................................................................... 11 
4.2     Advances in Understanding the Immuno-Biology of MCC ............................................... 12 
4.3     The Role of the Immune System in MCC and Emerging Therapies ................................ 14 
4.4     NK Cells and Their Therapeutic Use ............................................................................... 14 
4.5 
 Role of NK cells in Merkel Cell Cancer ............................................................................ 16 
4.6 
 NK-92 Cells ...................................................................................................................... 16 
4.7 
 Animal Studies with NK-92 Cells ..................................................................................... 17 
4.8 
 Safety of NK-92 Cells ....................................................................................................... 19 
4.9 
 Ex Vivo Expansion of NK-92 Cells ................................................................................... 20 
4.10   Human Trials with NK-92 Cells ........................................................................................ 20 
4.11   Rationale for Clinical Trial in Merkel Cell Cancer ............................................................ 21 
5.0   STUDY OBJECTIVES ........................................................................................... 22 
5.1     Primary Objective ............................................................................................................ 22 
5.2 
 Secondary Objectives ...................................................................................................... 22 
6.0  STUDY DESIGN .................................................................................................... 23 
6.1  
 Overview of Clinical Trial Design .................................................................................... 23 
7.0   SELECTION OF STUDY POPULATION ............................................................... 23 
7.1      Inclusion Criteria: ............................................................................................................ 23 
7.2      Exclusion Criteria: ........................................................................................................... 23 
7.3   Screen Failures ............................................................................................................... 25 
8.0  TREATMENT OF PATIENTS ................................................................................ 25 
8.1   Study Visits ..................................................................................................................... 25 
8.1.1   Screening Visit (Visit 1) ........................................................................................... 25 
8.1.2   NeukoplastTM Infusion Cycle 1 (Visit 2): .................................................................. 26 
8.1.3   NeukoplastTM Infusion Cycle 2 (Visit 3): .................................................................. 27 
8.1.4   Pre-Infusion Assessment Visits for Cycle 3 (Visit 4) and Cycle 4 (Visit 5): ............. 27 
8.1.5   NeukoplastTM Infusion Cycles 3 (Visit 5) and 4 (Visit 7): ......................................... 27 
8.1.6   4-Month (16 weeks) Follow-up Visit (Visit 8): .......................................................... 28 
8.1.7   Long Term Follow-up/Treatment ............................................................................. 28 
8.2 
  Concomitant Medications ................................................................................................ 29 
8.3 
  Disease Progression Assessments ................................................................................ 29 
8.4 
  Response Evaluation Criteria in Solid Tumors (RECIST) ............................................... 30 
8.4.1   Target and Non-Target Lesions .............................................................................. 30 
8.4.2    Evaluation of Target Lesions ................................................................................. 30 
8.4.3    Evaluation of Non-target Lesions ........................................................................... 31 
8.4.4    Evaluation of Best Overall Response .................................................................... 31 
8.5  
  Eastern Cooperative Oncology Group (ECOG) Performance Status ............................ 32 
8.6       Histological MCC Confirmation ...................................................................................... 32 
8.7       Clinical Laboratory Testing ............................................................................................ 33 
8.8       Immunologic Studies ..................................................................................................... 33 
8.8.1    NK-92-specific HLA Antibodies and T-Cell Response ........................................... 33 
 
8.8.2 Tumor Biopsy for NK-92 Presence (Optional)……………………………….……….33 
8.9 
   Quality of Life Questionnaire (QOL) ............................................................................... 34 
8.10     Off-Study Criteria ........................................................................................................... 34 
8.11  Physical Examination / Vital Signs / Height & Weight .................................................... 34 
9.0   INVESTIGATIONAL PRODUCT ........................................................................... 35 

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April 1, 2015 
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9.1   Neukoplast™ Preparation and Administration ................................................................ 35 
9.2   Investigational Product Accountability ............................................................................ 35 
10.0   SAFETY ASSESSMENTS .................................................................................. 36 
10.1   Adverse Events .............................................................................................................. 36 
10.1.1  Definitions .............................................................................................................. 36 
10.1.2  Reporting ............................................................................................................... 36 
10.1.3  Expectedness ........................................................................................................ 37 
10.1.4  Attribution ............................................................................................................... 37 
10.1.5  Grade ..................................................................................................................... 38 
10.2 Toxicity Stopping Rules .................................................................................................. 39 
10.3 Planned Protocol Safety Committee (PSC) Meeting ...................................................... 39 
10.4 Protocol Safety Committee ............................................................................................. 39 
11.0   DATA QUALITY ASSURANCE .......................................................................... 40 
12.0   STATISTICAL ANALYSIS .................................................................................. 40 
12.1   Primary Objective ........................................................................................................... 40 
12.2     Secondary Objectives .................................................................................................... 40 
12.3  Determination of Sample Size ....................................................................................... 40 
12.4  Statistical and Analytical Plans ...................................................................................... 41 
12.5  Analysis of Primary Endpoints ....................................................................................... 41 
12.6  Analysis of Secondary Endpoints .................................................................................. 42 
12.7  Toxicity Endpoint ............................................................................................................ 43 
12.8  Interim Analysis .............................................................................................................. 44 
13.0  INVESTIGATOR REGULATORY OBLIGATIONS ................................................ 44 
13.1  EC/IRB Approval ............................................................................................................ 44 
13.2  Pre-study Documentation .............................................................................................. 44 
13.3  Informed Consent .......................................................................................................... 45 
13.4  Protocol Adherence ....................................................................................................... 45 
13.5  Permission to Review Patients’ Source Records ........................................................... 45 
13.6  Protocol Amendments .................................................................................................... 46 
13.7  Change in Investigator ................................................................................................... 46 
13.8  Retention of Study Documents ...................................................................................... 46 
14.0  REFERENCES ...................................................................................................... 47 
 
 
 
Appendix A – Schedule of Events 
Appendix B – Functional Assessment of Cancer Therapy – General (Version 4) 

Conkwest, Inc.  
 
April 1, 2015 
Page 4 of 54 
 
 
 
     1.0  
INVESTIGATOR AGREEMENT 
 
I have read the attached Protocol entitled “Phase II Study of NeukoplastTM (NK-92) Infusions in 
Patients with Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma 
(MCC)” dated April 1, 2015.  I agree to abide by all provisions set forth herein.  I agree to comply 
with the International Conference on Harmonization Tripartite Guidelines on Good Clinical 
Practice, effective in the United States from 9 May 1997, and applicable United States Food and 
Drug Administration regulations set forth in 21 CFR §50, 54, 56, and 312.  I agree to ensure that 
the confidential information contained in this document will not be used for any purpose other than 
the evaluation and conduct of the clinical investigation without the prior written consent of 
Conkwest, Inc. 
 
 
 
 
____________________________________                              _____________ 
Signature of Investigator                                                               Date 
 
 
____________________________________ 
Printed Name of Investigator 
 
 
__________________________________________________ 
Address of Investigator 
 
 
____________________________________ 
Phone Number of Investigator 

Conkwest, Inc.  
 
April 1, 2015 
Page 5 of 54 
 
2.0   
LIST OF ABBREVIATIONS  
 
AE 
Adverse Event/Experience 
ALT 
Alanine transaminase 
AST 
Aspartate transaminase 
BUN 
Blood urea nitrogen 
CAR 
Chimeric antigen receptors 
CBC 
Complete blood count 
CFR 
Code of Federal Regulations 
CRA 
Clinical Research Associate 
CRF 
Case report form 
CRO 
Contract research organization 
CT 
Computed tomography 
CTC 
Common toxicity criteria 
EBV 
Epstein-Barr virus 
ECG 
Electrocardiogram 
ECOG 
Eastern Cooperative Oncology Group 
EC 
Ethics Committee 
FACT-G 
GCP 
HIV 
Functional Assessment of Cancer Therapy - General 
Good Clinical Practice 
Human immunodeficiency virus 
HLA 
IND 
Human Leukocyte Antigen 
Investigational New Drug 
IRB 
Institutional Review Board 
ISF 
IV 
Investigator Site File 
Intravenous 
LDL 
Low-density lipoprotein 
MCC 
Merkel Cell Carcinoma 
MCV 
Merkel cell polyomavirus 
MedDRA 
Medical Dictionary for Regulatory Activities 
mg 
Milligram 
mm 
millimeter 
MRI 
Magnetic resonance imaging 
NCI 
National Cancer Institute 
NK 
Natural Killer 
OS 
Overall Survival 
PFS 
Progression free survival 
QOL 
Quality of Life 
RECIST 
Response Evaluation Criteria in Solid Tumors 
SAE 
Serious adverse event 
SCID 
Severe combined immunodeficiency 
SOP 
Standard operating procedure 
TIL 
Tumor infiltrating lymphocytes 
TTP 
WBC 
Time to disease progression 
White blood cell 
 

Conkwest, Inc.  
 
April 1, 2015 
Page 6 of 54 
 
 
 
 
3.0   
STUDY SYNOPSIS 
Title of Study: 
 
Phase II Study of NeukoplastTM (NK-92) Infusions in Patients with Unresectable Stage III 
(IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 
Objectives: 
 
Primary Objective: 
a) Determine the effect of NeukoplastTM infusions on the 4-month (~16 
weeks) progression-free survival (PFS) rate in patients with unresectable 
stage III (IIIB) or distant metastatic (stage IV) MCC based on Response 
Evaluation Criteria in Solid Tumors (RECIST) (v1.1). 
Secondary Objectives: 
a) Determine the overall response rate, as assessed by RECIST at week 16 
b) Time to disease progression 
c) Median overall survival 
d) Assess the safety and toxicity of NeukoplastTM 
e) Quality of life assessment (FACT-G) 
 
Study Design: 
 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect 
of NeukoplastTM infusions in patients with unresectable stage III (IIIB) or distant 
metastatic (stage IV) MCC.  The study will use an adaptive Simon optimal two-stage 
design.  This two-stage design detects efficacy signals, allows for early assessment and 
avoids enrolling larger numbers of patients in case of inefficacy.  In the first stage, 12 
patients with unresectable stage III (IIIB) or distant metastatic (stage IV) MCC will be 
enrolled and treated. If the treatment combination in the first stage can improve the 4-
month progression free survival (PFS) rate from 4% to 20% [e.g. at least 1 patient out of 
12 patients has PFS ≥ 16 weeks (4 months)], then the study will proceed to the second 
stage, in which 12 more patients will be enrolled and treated.  In addition, there will be a 
planned Protocol Safety Committee meeting after the first 6 patients are enrolled in order 
to assess the safety of NeukoplastTM infusions (see section 10.3).  NeukoplastTM will be 
given via IV infusion at a dose of 2 x 109 cells/m2 on two consecutive days (= 1 cycle) 
every 4 weeks for a total of 4 cycles (8 infusions). If there is evidence of disease 

Conkwest, Inc.  
 
April 1, 2015 
Page 7 of 54 
 
progression believed to be unrelated to an inflammatory immune mediated response, at 
any time point after the second cycle, the patient will be withdrawn from the trial.   
 
Number of Patients: 
 
Approximately 24 treated in two consecutive cohorts of 12 patients. 
 
Duration of Treatment: 
 
The total duration of planned treatment is 4 months. 
 
Inclusion Criteria: 
 
1. Male or female patients 18 years of age or older.  
2. Patients must have histologically confirmed Merkel Cell Carcinoma (MCC) that is 
inoperable Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging 
criteria for MCC(2). Patients with stage IIIB MCC must have been evaluated by a 
surgical oncologist who has documented that their disease is surgically 
unresectable.  MCC of unknown primary is allowed. 
3. Up to two prior cytotoxic chemotherapies and/or novel immunotherapy 
treatments for MCC are allowed. 
4. ECOG performance status of 0-2. 
5. Voluntary written informed consent must be given before performance of any 
study-related procedure not part of normal medical care, with the understanding 
that consent may be withdrawn by the patient at any time without prejudice to 
future medical care.  
 
Exclusion Criteria: 
 
1.  Major surgery within 30 days before study entry. 
2.  Any of the following clinical laboratory values at the time of enrollment: 
a. Absolute neutrophil count (ANC)  < 1,000 cells/mm3, 
b. Platelets < 50,000 x 109/L 
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation 
(e.g. AST, ALT, GGT) > 2x the ULN. Elevation related to direct tumor infiltration is 
allowed. 
4. Renal insufficiency as indicated by a creatinine level > 2 x the ULN.  
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital 

Conkwest, Inc.  
 
April 1, 2015 
Page 8 of 54 
 
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe 
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or 
significant conduction system abnormalities in the opinion of the Investigator.  
Prior to study entry any known abnormality on electrocardiogram (ECG) must be 
determined and documented by the Investigator to be not clinically significant to 
the patient participation in this study. 
6.  Any condition, including laboratory abnormalities, that in the opinion of the 
investigator places the patient at unacceptable risk if he/she were to participate in 
the study.  This includes, but is not limited, to serious medical conditions or 
psychiatric illness likely to interfere with participation in this clinical study. 
7. Female patients who are pregnant or breastfeeding. Female patients of 
childbearing potential must have a negative pregnancy test and agree to use 
adequate contraception for the duration of the trial. 
8. Patients with other malignancies are not eligible. However, given the frequent 
coexistence of MCC with other malignancies, the following exceptions are 
allowed:  
a) If they have been continuously disease-free for any solid tumor malignancy 
>3 years prior to the time of enrollment.  
b) Patients with basal cell carcinoma or squamous cell carcinoma  
c) Patients with prior history of in situ cancer (e.g. breast, melanoma, 
squamous cells carcinoma of the skin, cervical),  
d) Patients with prior history of prostate cancer that is not under active 
systemic treatment except hormonal therapy, but with undetectable PSA 
(<0.2ng/mL),  
e) Patients with chronic lymphocytic leukemia are eligible if they have isolated 
lymphocytosis (Rai stage O) on the condition that they do not require 
systemic treatment for their disease [“B” symptoms, Richter’s transformation, 
lymphocyte 
doubling 
time 
(<6 
months) 
and 
they 
do 
not 
have 
lymphadenopathy of hepatosplenomegaly]. 
f) Patients with lymphoma of any type or hairy cell leukemia are eligible on the 
condition that they do not receive active systemic treatment for their 
hematologic disease and are in complete remission as evidenced by 
PET/CT scans and bone marrow biopsies for at least 3 months. 
       9.  Patients on immunosuppressants, systemic corticosteroids or any other 

Conkwest, Inc.  
 
April 1, 2015 
Page 9 of 54 
 
investigational product. 
Investigational Product and Administration: 
 
Neukoplast™ (from Conkwest, Inc.) will be provided for clinical administration from a 
GMP contract manufacturer (CMO).  The production/expansion (in vitro) of Neukoplast™ 
will be according to the standard operating procedures on file at the GMP cell processing 
facility in accordance with CMO procedures and in accordance with information 
contained in BB-IND 8404 entitled “Natural Killer Cell Line, Neukoplast™ (NK-92), 
Expanded with Interleukin-2 (Novartis)”; IND Sponsor: Conkwest, Inc. Cells will be 
shipped from the CMO to the study site according to validated procedures detailed in the 
IND.    Cells will be washed and concentrated at the clinical site. In order to prevent 
Neukoplast™ cell proliferation, the Neukoplast™ cells will be irradiated with 1000 cGy 
prior to infusion at the study site. The cells for the second day infusion will be kept 
overnight in the Cell Processing facility under controlled cell culture incubator conditions. 
 
Efficacy Evaluation: 
 
The 4-month PFS rate will be calculated as the number of patients alive and progression 
free (based on RECIST v1.1) at four months from the date of 1st infusion divided by the 
total number of patients.  For purposes of this analysis, the 4-month PFS rate will be 
calculated with 4 months being based on greater than or equal to 112 days (e.g., 
patients alive and progression-free for at least 112 days will be counted in the numerator 
of the PFS rate calculation).   
 
Safety Evaluation: 
 
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, 
changes on physical exams, and laboratory values.  All clinically significant findings on 
any post-baseline tests will be reported as AEs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities.   Treatment-emergent AEs will be defined as 
those events with start dates on or after the date of the first infusion or events that were 
present prior to the start of treatment but worsened in severity following the first infusion 
on Cycle 1/Day 1. 
   

Conkwest, Inc.  
 
April 1, 2015 
Page 10 of 54 
 
Toxicity Stopping Rule: 
 
To avoid exposure of patients to unnecessary toxicity, continuous toxicity monitoring will 
be performed throughout the study. The trial will be stopped for toxicity if the death rate 
attributed to therapy (and not to the natural history of disease) significantly exceeds 5% 
during the first 12 weeks of treatment. Specifically, using a Pocock type stopping 
boundary which assumes that the death rate attributed to therapy of 0.05 is the 
maximum acceptable rate, the trial will be stopped if ≥2 deaths are observed in the first 6 
patients or ≥3 deaths are observed in the first 9 patients.  If ≥4 deaths are observed in 
the first cohort of 12 patients, enrollment into the second cohort will be halted.  If none of 
the toxicity stopping rules are met, enrollment into the next cohort may be initiated.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Conkwest, Inc.  
 
April 1, 2015 
Page 52 of 54 
 
Appendix A – Schedule of Events 
Study Period 
Screening 
NeukoplastTM Treatment 
 
4-Month 
Follow-up  
Study Visits 
Visit 1 
Visit 2 
Cycle 1 
Visit 3 
Cycle 2 
Pre-Infusion 
Assessment 
Visit 4, 6 
Visit 5, 7 
Cycles 3 & 4 
 
Visit 8 
Visit Timeframe / 
Window 
- 21 days 
 Day 0    
(+/- 7 days) 
Week 4     
(+/- 7 days) 
Within 2 weeks 
of next cycle 
 Weeks 8 &12 
(+/- 7 days) 
16 weeks 
Informed Consent 
X 
 
 
 
 
 
Eligibility Criteria 
X 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
Physical Exam 
X 
 
 
X 
 
X 
Vitals 
X 
X1 
X1 
X 
X1 
X 
Height and Weight 
X 
X 
X 
 
X 
X 
CT/MRI 
X 
 
 
 
 
X 
12-lead ECG 
X 
 
 
X 
 
X 
ECOG  
X 
 
 
X 
 
X 
QOL 
Questionnaire 
X 
 
 
X 
 
X 
Pregnancy Test 
X 
 
 
X 
 
X 
Chemistries / 
Hematology/UA 
X 
 
 
X 
 
X 
Immunologic 
Studies2 
X2 
 
X2 
 
X2 
X2 
Concomitant 
Medications 
X 
 
 
X 
 
X 
Adverse Events 
 
 
X 
X 
X 
X 
Tumor Biopsy 
(Optional)5 
 
X 
 
 
 
 
NeukoplastTM 
Infusion 
 
X 
X 
 
X 
 
Disease 
Progression 4 
 
 
 
X 
 
X 
Survival Status 3 
 
 
 
 
 
X 
1 - Vital signs will be recorded at 0, 15(+/- 3 minutes), 30(+/- 3 minutes), 60(+/- 5 minutes), 90(+/- 5 minutes) and 
120(+/- 5 minutes) from the start of the infusion.. 
2 - The development of NK-92-specific HLA antibodies and NK-92-specific T-Cell response will be evaluated at 
baseline, 4 weeks and 8 weeks post Cycle 1/Day 2.  The 4-week sample will be collected prior to the administration of 
Cycle 2 and the 8-week sample will be collected prior to the administration of Cycle 3. 
3 - Patient will be followed for survival status until death or lost to follow-up. 
4 - These assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, or 
radiographic imaging (x-ray, computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic 
resonance imaging [MRI], or ultrasound).  The same radiologic imaging method should be used consistently throughout 
the study to avoid variability in results. 
5 - In order to examine possible tumor infiltration by NK-92, an optional biopsy will be collected approximately 5-7 days 
after Cycle 1 completion (Cycle 1/Day 2). This biopsy will be optional depending on the patient situation and the location 
of the tumor and will be collected according tot eh site’s standard of care procedures (see section 8.8.2).   
 

CLINICAL TRIAL PROTOCOL 
______________________________________________________________________ 
Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with 
Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 Protocol Date: October 20, 2015 
Amendment 3 
Protocol Version: 4 
Protocol Number: MCC-001 
Study Sponsor: 
NantKwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact: 
Karen Nichols 
Vice President, Regulatory and Quality 
Karen.Nichols@NantKwest.com 
Disclosure Statement:  This document contains information that is confidential and proprietary to 
NantKwest. This information is being provided to you solely for the purpose of evaluating and/or 
conducting a clinical trial for NantKwest.  You may disclose the contents of this protocol only to study 
personnel under your supervision, Independent Ethics Committee/Institutional Review Board or duly 
authorized representatives of regulatory agencies.  The foregoing shall not apply to disclosure required by 
any regulations; however, you will give prompt notice to NantKwest of any such disclosure. 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 4 of 60 
 
     1.0  
INVESTIGATOR AGREEMENT 
 
I have read the attached Protocol entitled “Phase II Study of aNK (activated NK-92, formerly 
Neukoplast) Infusions in Patients with Unresectable Stage III (IIIB) or Distant Metastatic (IV) 
Merkel Cell Carcinoma (MCC)” dated October 20, 2015.  I agree to abide by all provisions set 
forth herein.  I agree to comply with the International Conference on Harmonization Tripartite 
Guidelines on Good Clinical Practice, effective in the United States from May 9, 1997, and 
applicable United States Food and Drug Administration regulations set forth in 21 CFR §50, 54, 
56, and 312.  I agree to ensure that the confidential information contained in this document will 
not be used for any purpose other than the evaluation and conduct of the clinical investigation 
without the prior written consent of NantKwest, Inc. 
 
 
 
 
____________________________________                              _____________ 
Signature of Investigator                                                               Date 
 
 
____________________________________ 
Printed Name of Investigator 
 
 
__________________________________________________ 
Address of Investigator 
 
 
____________________________________ 
Phone Number of Investigator 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 6 of 60 
 
3.0   
STUDY SYNOPSIS 
Title of Study: 
 
Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with 
Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 
Objectives: 
Primary Objective: 
Determine the effect of aNK infusions on the 4-month (~16 weeks) progression-free 
survival (PFS) rate in patients with unresectable stage III (IIIB) or distant metastatic 
(stage IV) MCC based on Response Evaluation Criteria in Solid Tumors (RECIST) 
(v1.1). 
Secondary Objectives: 
a) Determine the overall response rate, as assessed by RECIST at week 16 
b) Time to disease progression 
c) Median overall survival 
d) Assess the safety and toxicity of aNK 
e) Quality of life assessment (FACT-G) 
 
Exploratory Objectives: 
To determine the genomic and proteomic profile of subjects’ tumors to identify gene 
mutations, gene amplifications, RNA-expression levels, and protein-expression levels.  
Correlations between genomic/proteomic profiles and efficacy outcomes will be 
assessed. 
Study Design: 
 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect 
of aNK infusions in patients with unresectable stage III (IIIB) or distant metastatic (stage 
IV) MCC.  The study will use an adaptive Simon optimal two-stage design.  This two-
stage design detects efficacy signals, allows for early assessment and avoids enrolling 
larger numbers of patients in case of inefficacy.  In the first stage, 12 patients with 
unresectable stage III (IIIB) or distant metastatic (stage IV) MCC will be enrolled and 
treated. If the treatment combination in the first stage can improve the 4-month 
progression free survival (PFS) rate from 4% to 20% [e.g. at least 1 patient out of 12 
patients has PFS ≥ 16 weeks (4 months)], then the study will proceed to the second 
stage, in which 12 more patients will be enrolled and treated.  In addition, there will be a 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 7 of 60 
 
planned Protocol Safety Committee meeting after the first 6 patients are enrolled in order 
to assess the safety of aNK infusions (see section 10.3).   aNK will be given via IV 
infusion at a dose of 2 x 109 cells/m2 on two consecutive days (= 1 cycle) every 2 weeks 
for a total of 8 cycles (16 infusions). If there is evidence of disease progression believed 
to be unrelated to an inflammatory immune mediated response, at any time point after 
the fourth cycle, the patient will be withdrawn from the trial.   
 
Number of Patients: 
 
Approximately 24 treated in two consecutive cohorts of 12 patients. 
 
Duration of Treatment: 
 
The total duration of planned treatment is 4 months. 
 
Inclusion Criteria: 
 
1. Male or female patients 18 years of age or older.  
2. Patients must have histologically confirmed Merkel Cell Carcinoma (MCC) that is 
inoperable Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging 
criteria for MCC(2). Patients with stage IIIB MCC must have been evaluated by a 
surgical oncologist who has documented that their disease is surgically 
unresectable.  MCC of unknown primary is allowed. 
3. Up to two prior systemic cytotoxic chemotherapies and/or novel immunotherapy 
treatments for MCC are allowed. A wash-out period of 2 weeks prior to screening 
is required. 
4. ECOG performance status of 0-2. 
5. Voluntary written informed consent must be given before performance of any 
study-related procedure not part of normal medical care, with the understanding 
that consent may be withdrawn by the patient at any time without prejudice to 
future medical care.  
 
Exclusion Criteria: 
 
1.  Major surgery within 30 days before study entry. 
2.  Any of the following clinical laboratory values at the time of enrollment: 
a. Absolute neutrophil count (ANC)  < 1,000 cells/mm3, 
b. Platelets < 50,000 x 109/L 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 8 of 60 
 
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation 
(e.g. AST, ALT, GGT) > 2x the ULN. Elevation related to direct tumor infiltration is 
allowed. 
4. Renal insufficiency as indicated by a creatinine level > 2 x the ULN.  
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital 
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe 
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or 
significant conduction system abnormalities in the opinion of the Investigator.  
Prior to study entry any known abnormality on electrocardiogram (ECG) must be 
determined and documented by the Investigator to be not clinically significant to 
the patient participation in this study. 
6.  Any condition, including laboratory abnormalities, that in the opinion of the 
investigator places the patient at unacceptable risk if he/she were to participate in 
the study.  This includes, but is not limited, to serious medical conditions or 
psychiatric illness likely to interfere with participation in this clinical study. 
7. Female patients who are pregnant or breastfeeding. Female patients of 
childbearing potential must have a negative pregnancy test and agree to use 
adequate contraception for the duration of the trial. 
8. Patients with other malignancies, or brain metastasis, are not eligible. However, 
given the frequent coexistence of MCC with other malignancies, the following 
exceptions are allowed:  
a) If they have been continuously disease-free for any solid tumor malignancy 
>3 years prior to the time of enrollment.  
b) Patients with basal cell carcinoma or squamous cell carcinoma,  
c) Patients with prior history of in situ cancer (e.g. breast, melanoma, 
squamous cells carcinoma of the skin, cervical),  
d) Patients with prior history of prostate cancer that is not under active 
systemic treatment except hormonal therapy, but with undetectable PSA 
(<0.2ng/mL),  
e) Patients with chronic lymphocytic leukemia are eligible if they have isolated 
lymphocytosis (Rai stage O) on the condition that they do not require 
systemic treatment for their disease [“B” symptoms, Richter’s transformation, 
lymphocyte 
doubling 
time 
(<6 
months) 
and 
they 
do 
not 
have 
lymphadenopathy of hepatosplenomegaly]. 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 9 of 60 
 
f) Patients with lymphoma of any type or hairy cell leukemia are eligible on the 
condition that they do not receive active systemic treatment for their 
hematologic disease and are in complete remission as evidenced by 
PET/CT scans and bone marrow biopsies for at least 3 months. 
       9.  Patients on immunosuppressants, systemic corticosteroids or any other  
investigational product. 
Investigational Product and Administration: 
 
 aNK (activated NK-92, formerly Neukoplast) will be provided for clinical administration 
from a GMP contract manufacturer (CMO).  The production/expansion (in vitro) of aNK 
will be according to the standard operating procedures on file at the GMP cell processing 
facility in accordance with CMO procedures and in accordance with information 
contained in BB-IND 8404 entitled “Natural Killer Cell Line, aNK (activated NK-92, 
formerly Neukoplast), Expanded with Interleukin-2 (Novartis)”; IND Sponsor: NantKwest, 
Inc. Cells will be shipped from the CMO to the study site according to validated 
procedures detailed in the IND.    Cells will be washed and concentrated at the clinical 
site. In order to prevent aNK cell proliferation, the aNK cells will be irradiated with 1000 
cGy prior to infusion at the study site. The cells for the second day infusion will be kept 
overnight in the Cell Processing facility under controlled cell culture incubator conditions. 
 
Efficacy Evaluation: 
 
The 4-month PFS rate will be calculated as the number of patients alive and progression 
free (based on RECIST v1.1) at four months from the date of 1st infusion divided by the 
total number of patients.  For purposes of this analysis, the 4-month PFS rate will be 
calculated with 4 months being based on greater than or equal to 112 days (e.g., 
patients alive and progression-free for at least 112 days will be counted in the numerator 
of the PFS rate calculation).   
 
Safety Evaluation: 
 
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, 
changes on physical exams, and laboratory values.  All clinically significant findings on 
any post-baseline tests will be reported as AEs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities.   Treatment-emergent AEs will be defined as 
those events with start dates on or after the date of the first infusion or events that were 

NantKwest, Inc.  
 
October 20, 2015 
 
Page 10 of 60 
 
present prior to the start of treatment but worsened in severity following the first infusion 
on Cycle 1/Day 1. 
   
Exploratory Molecular Profiling and Analysis:  
Genomic sequencing of tumor cells relative to non-tumor cells to identify the genomic 
variances that may contribute to response or disease progression and provide an 
understanding of molecular abnormalities; RNA sequencing (RNAseq) to provide 
expression data and give relevance to DNA mutations; and quantitative proteomics to 
determine the concentration of proteins and to confirm expression of genes predictive of 
response and disease progression.   
 
Toxicity Stopping Rule: 
 
To avoid exposure of patients to unnecessary toxicity, continuous toxicity monitoring will 
be performed throughout the study. The trial will be stopped for toxicity if the death rate 
attributed to therapy (and not to the natural history of disease) significantly exceeds 5% 
during the first 12 weeks of treatment. Specifically, using a Pocock type stopping 
boundary which assumes that the death rate attributed to therapy of 0.05 is the 
maximum acceptable rate, the trial will be stopped if ≥2 deaths are observed in the first 6 
patients or ≥3 deaths are observed in the first 9 patients.  If ≥4 deaths are observed in 
the first cohort of 12 patients, enrollment into the second cohort will be halted.  If none of 
the toxicity stopping rules are met, enrollment into the next cohort may be initiated.  
 
 
 
 
 
 
 
 
 
 
 
 

NantKwest, Inc.  
 
October 20, 2015 
Page 56 of 60 
 
Appendix A – Schedule of Events 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
4-Month 
Follow-up 
Study Visits 
Visit 1 
Visits 2,3,4,5 
aNK Cycle 1-4 
Visit 6 
Assessment Visit  
Visits 7,8 
aNK Cycles 5-6 
Visit 9 
Assessment Visit  
Visits 10,11 
aNK Cycles 7-8 
 
Visit 12 
Visit Timeframe / 
Window 
- 21 days 
 Day 0 
Week 2 
Week 4 
Week 6 
Week 7 
 
 Week 8 
Week 10    
Week 11 
Week 12 
Week 14 
 
16 weeks 
Informed Consent 
X 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Physical Exam 
X 
 
X 
 
X 
 
X 
Vitals 
X 
X1 
X 
X1 
X 
X1 
X 
Height and Weight 
X 
X 
X 
X 
X 
X 
X 
CT/MRI 
X 
 
 
 
 
 
X 
12-lead ECG 
X 
 
X 
 
X 
 
X 
ECOG  
X 
 
X 
 
X 
 
X 
QOL Questionnaire 
X 
 
X 
 
X 
 
X 
Pregnancy Test 
X 
 
X 
 
X 
 
X 
Chemistries / 
Hematology / UA 
X 
 
X 
 
X 
 
X 
Immunologic Studies2 
X2 
X2 
 
X2 
 
 
 
Concomitant Meds 
X 
 
X 
 
X 
 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
Genomic/Proteomic 
Molecular Sampling5 
X 
 
 
 
 
 
 
Tumor Biopsy6 
 
X 
 
 
 
 
 
 aNK Infusion 
 
X 
 
X 
 
X 
 
Disease Progression 4 
 
 
X 
 
X 
 
X 
Survival Status 3 
 
 
 
 
 
 
X3 

NantKwest, Inc.  
 
October 20, 2015 
Page 57 of 60 
 
 
1 - Vital signs will be recorded at 0, 15(+/- 3 minutes), 30(+/- 3 minutes), 60(+/- 5 minutes), 90(+/- 5 minutes) and 120(+/- 5 minutes) from the start of the infusion.. 
2 - The development of NK-92-specific HLA antibodies and NK-92-specific T-Cell response will be evaluated at baseline, 4 weeks and 8 weeks post Cycle 1/Day 2.  The 
4-week sample will be collected prior to the administration of Cycle 3 and the 8-week sample will be collected prior to the administration of Cycle 5. 
3 - Patient will be followed for survival status until death or lost to follow-up. 
4 - These assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, or radiographic imaging (x-ray, computed tomography 
[CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging method should be used 
consistently throughout the study to avoid variability in results. 
5 - Exploratory genomics and proteomics molecular profiling will be performed on formalin-fixed, paraffin embedded (FFPE) tumor tissue and whole blood (subject 
matched normal comparator against the tumor tissue) by next-generation sequencing and mass spectrometry-based quantitative proteomics. 
6 - In order to examine possible tumor infiltration by NK-92, an optional biopsy will be collected within 7 days after Cycle 1 completion (Cycle 1/Day 2). This biopsy will 
be optional depending on the patient situation and the location of the tumor and will be collected according tot eh site’s standard of care procedures (see section 8.8.2).   
 

CLINICAL TRIAL PROTOCOL 
______________________________________________________________________ 
Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with 
Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 Protocol Date: May 10, 2016 
Amendment 4 
Protocol Version: 5 
Protocol Number: MCC-001 
Study Sponsor: 
NantKwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact: 
Karen Nichols 
Vice President, Regulatory and Quality 
Karen.Nichols@NantKwest.com 
Disclosure Statement:  This document contains information that is confidential and proprietary to 
NantKwest. This information is being provided to you solely for the purpose of evaluating and/or 
conducting a clinical trial for NantKwest.  You may disclose the contents of this protocol only to study 
personnel under your supervision, Independent Ethics Committee/Institutional Review Board or duly 
authorized representatives of regulatory agencies.  The foregoing shall not apply to disclosure required by 
any regulations; however, you will give prompt notice to NantKwest of any such disclosure. 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 5 of 63 
 
     1.0  
INVESTIGATOR AGREEMENT 
 
I have read the attached Protocol entitled “Phase II Study of aNK (activated NK-92, formerly 
Neukoplast) Infusions in Patients with Unresectable Stage III (IIIB) or Distant Metastatic (IV) 
Merkel Cell Carcinoma (MCC)” dated May 10, 2016.  I agree to abide by all provisions set forth 
herein.  I agree to comply with the International Conference on Harmonization Tripartite 
Guidelines on Good Clinical Practice, effective in the United States from May 9, 1997, and 
applicable United States Food and Drug Administration regulations set forth in 21 CFR §50, 54, 
56, and 312.  I agree to ensure that the confidential information contained in this document will 
not be used for any purpose other than the evaluation and conduct of the clinical investigation 
without the prior written consent of NantKwest, Inc. 
 
 
 
 
____________________________________                              _____________ 
Signature of Investigator                                                               Date 
 
 
____________________________________ 
Printed Name of Investigator 
 
 
__________________________________________________ 
Address of Investigator 
 
 
____________________________________ 
Phone Number of Investigator 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 7 of 63 
 
3.0   
STUDY SYNOPSIS 
Title of Study: 
 
Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with 
Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
 
Objectives: 
Primary Objective: 
Determine the effect of aNK infusions on the 4-month (~16 weeks) progression-free 
survival (PFS) rate in patients with unresectable stage III (IIIB) or distant metastatic 
(stage IV) MCC based on Response Evaluation Criteria in Solid Tumors (RECIST) 
(v1.1). 
Secondary Objectives: 
a) Determine the overall response rate, as assessed by RECIST at week 16 
b) Time to disease progression 
c) Median overall survival 
d) Assess the safety and toxicity of aNK 
e) Quality of life assessment (FACT-G) 
 
Exploratory Objectives: 
To determine the genomic and proteomic profile of subjects’ tumors to identify gene 
mutations, gene amplifications, RNA-expression levels, and protein-expression levels.  
Correlations between genomic/proteomic profiles and efficacy outcomes will be 
assessed. 
Study Design: 
 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect 
of aNK infusions in patients with unresectable stage III (IIIB) or distant metastatic (stage 
IV) MCC.  The study will use an adaptive Simon optimal two-stage design.  This two-
stage design detects efficacy signals, allows for early assessment and avoids enrolling 
larger numbers of patients in case of inefficacy.  In the first stage, 12 patients with 
unresectable stage III (IIIB) or distant metastatic (stage IV) MCC will be enrolled and 
treated. If the treatment combination in the first stage can improve the 4-month 
progression free survival (PFS) rate from 4% to 20% [e.g. at least 1 patient out of 12 
patients has PFS ≥ 16 weeks (4 months)], then the study will proceed to the second 
stage, in which 12 more patients will be enrolled and treated.  In addition, there will be a 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 8 of 63 
 
planned Protocol Safety Committee meeting after the first 6 patients are enrolled in order 
to assess the safety of aNK infusions (see section 10.3).   aNK will be given via IV 
infusion at a dose of 2 x 109 cells/m2 on two consecutive days (= 1 cycle) every 2 weeks 
for a total of 8 cycles (16 infusions). If there is evidence of disease progression believed 
to be unrelated to an inflammatory immune mediated response, at any time point after 
the fourth cycle, the patient will be withdrawn from the trial.   
 
Number of Patients: 
 
Approximately 24 treated in two consecutive cohorts of 12 patients. 
 
Duration of Treatment: 
 
The total duration of planned treatment is 4 months. 
 
Inclusion Criteria: 
 
1. Male or female patients 18 years of age or older.  
2. Patients must have histologically confirmed Merkel Cell Carcinoma (MCC) that is 
inoperable Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging 
criteria for MCC(2). Patients with stage IIIB MCC must have been evaluated by a 
surgical oncologist who has documented that their disease is surgically 
unresectable.  MCC of unknown primary is allowed. 
3. Up to two prior systemic cytotoxic chemotherapies and/or novel immunotherapy 
treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK 
treatment is required. 
4. ECOG performance status of 0-2. 
5. Voluntary written informed consent must be given before performance of any 
study-related procedure not part of normal medical care, with the understanding 
that consent may be withdrawn by the patient at any time without prejudice to 
future medical care.  
 
Exclusion Criteria: 
 
1.  Major surgery within 30 days before study entry. 
2.  Any of the following clinical laboratory values at the time of enrollment: 
a. Absolute neutrophil count (ANC)  < 1,000 cells/mm3, 
b. Platelets < 50,000 x 109/L 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 9 of 63 
 
3. Liver function abnormalities as indicated by ongoing hepatic enzyme elevation 
(e.g. AST, ALT, GGT) > 2x the ULN. Elevation related to direct tumor infiltration is 
allowed. 
4. Renal insufficiency as indicated by a creatinine level > 2 x the ULN.  
5. Myocardial infarction within 6 months prior to enrollment or New York Hospital 
Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe 
uncontrolled arrhythmias, or electrocardiographic evidence of acute ischemia or 
significant conduction system abnormalities in the opinion of the Investigator.  
Prior to study entry any known abnormality on electrocardiogram (ECG) must be 
determined and documented by the Investigator to be not clinically significant to 
the patient participation in this study. 
6.  Any condition, including laboratory abnormalities, that in the opinion of the 
investigator places the patient at unacceptable risk if he/she were to participate in 
the study.  This includes, but is not limited, to serious medical conditions or 
psychiatric illness likely to interfere with participation in this clinical study. 
7. Female patients who are pregnant or breastfeeding. Female patients of 
childbearing potential must have a negative pregnancy test and agree to use 
adequate contraception for the duration of the trial. 
8. Patients with other malignancies, or brain metastasis, are not eligible. However, 
given the frequent coexistence of MCC with other malignancies, the following 
exceptions are allowed:  
a) If they have been continuously disease-free for any solid tumor malignancy 
>3 years prior to the time of enrollment.  
b) Patients with basal cell carcinoma or squamous cell carcinoma,  
c) Patients with prior history of in situ cancer (e.g. breast, melanoma, 
squamous cells carcinoma of the skin, cervical),  
d) Patients with prior history of prostate cancer that is not under active 
systemic treatment except hormonal therapy, but with undetectable PSA 
(<0.2ng/mL),  
e) Patients with chronic lymphocytic leukemia are eligible if they have isolated 
lymphocytosis (Rai stage O) on the condition that they do not require 
systemic treatment for their disease [“B” symptoms, Richter’s transformation, 
lymphocyte 
doubling 
time 
(<6 
months) 
and 
they 
do 
not 
have 
lymphadenopathy of hepatosplenomegaly]. 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 10 of 63 
 
f) Patients with lymphoma of any type or hairy cell leukemia are eligible on the 
condition that they do not receive active systemic treatment for their 
hematologic disease and are in complete remission as evidenced by 
PET/CT scans and bone marrow biopsies for at least 3 months. 
       9.  Patients on immunosuppressants, systemic corticosteroids or any other 
investigational product. 
Investigational Product and Administration: 
 
 aNK (activated NK-92, formerly Neukoplast) will be provided for clinical administration 
from a GMP contract manufacturer (CMO).  The production/expansion (in vitro) of aNK 
will be according to the standard operating procedures on file at the GMP cell processing 
facility in accordance with CMO procedures and in accordance with information 
contained in BB-IND 8404 entitled “Natural Killer Cell Line, aNK (activated NK-92, 
formerly Neukoplast), Expanded with Interleukin-2 (Novartis)”; IND Sponsor: NantKwest, 
Inc. Cells will be shipped from the CMO to the study site according to validated 
procedures detailed in the IND.    Cells will be washed and concentrated at the clinical 
site. In order to prevent aNK cell proliferation, the aNK cells will be irradiated with 1000 
cGy prior to infusion at the study site. The cells for the second day infusion will be kept 
overnight in the Cell Processing Facility under controlled cell culture incubator 
conditions. 
 
Efficacy Evaluation: 
 
The 4-month PFS rate will be calculated as the number of patients alive and progression 
free (based on RECIST v1.1) at four months from the date of 1st infusion divided by the 
total number of patients.  For purposes of this analysis, the 4-month PFS rate will be 
calculated with 4 months being based on greater than or equal to 112 days (e.g., 
patients alive and progression-free for at least 112 days will be counted in the numerator 
of the PFS rate calculation).   
 
Safety Evaluation: 
 
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, 
changes on physical exams, and laboratory values.  All clinically significant findings on 
any post-baseline tests will be reported as AEs. Adverse events will be coded using the 
Medical Dictionary for Regulatory Activities.   Treatment-emergent AEs will be defined as 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 11 of 63 
 
those events with start dates on or after the date of the first infusion or events that were 
present prior to the start of treatment but worsened in severity following the first infusion 
on Cycle 1/Day 1. 
   
Exploratory Molecular Profiling and Analysis:  
Genomic sequencing of tumor cells relative to non-tumor cells to identify the genomic 
variances that may contribute to response or disease progression and provide an 
understanding of molecular abnormalities; RNA sequencing (RNAseq) to provide 
expression data and give relevance to DNA mutations; and quantitative proteomics to 
determine the concentration of proteins and to confirm expression of genes predictive of 
response and disease progression.   
 
Exploratory Tumor Biopsy  
 
In order to examine possible tumor infiltration by aNK, exploratory tumor biopsies may 
be collected at suitable time points throughout the study in order to capture possible 
changes in T cell infiltration.  These optional tumor biopsies may be collected 
at Baseline, 48-72 hours after completion of Cycle 1 and again at 4 weeks post 
completion of Cycle 1.   A tumor biopsy may also be taken at the time of disease 
progression if pseudo progression needs to be excluded and biopsy analysis may guide 
in resulting treatment decisions. Per Investigator discretion, tissue should be obtained 
through either surgical or punch/core biopsy methods.   Biopsies that are collected 
outside of a planned study visit will be captured as an unscheduled study visit. Biopsy 
samples should be collected and stored and shipped according to the MCC-001 Biopsy 
Collection Guideline.  
Toxicity Stopping Rule: 
 
To avoid exposure of patients to unnecessary toxicity, continuous toxicity monitoring will 
be performed throughout the study. The trial will be stopped for toxicity if the death rate 
attributed to therapy (and not to the natural history of disease) significantly exceeds 5% 
during the first 12 weeks of treatment. Specifically, using a Pocock type stopping 
boundary which assumes that the death rate attributed to therapy of 0.05 is the 
maximum acceptable rate, the trial will be stopped if ≥2 deaths are observed in the first 6 
patients or ≥3 deaths are observed in the first 9 patients.  If ≥4 deaths are observed in 
the first cohort of 12 patients, enrollment into the second cohort will be halted.  If none of 
the toxicity stopping rules are met, enrollment into the next cohort may be initiated.  

NantKwest, Inc.  
 
 May 10, 2016 
Page 59 of 63 
 
 
Appendix A – Schedule of Events 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
End of 
Study Visit 
Study Visits 
Visit 1 
Visits 2,3,4,5 
aNK Cycle 1-4 
Visit 6 
Assessment Visit  
Visits 7,8 
aNK Cycles 5-6 
Visit 9 
Assessment Visit  
Visits 10,11 
aNK Cycles 7-8 
 
Visit 12 
Visit Timeframe / 
Window 
- 21 days 
 Day 0 
Week 2 
Week 4 
Week 6 
Week 7 
 
 Week 8 
Week 10    
Week 11 
Week 12 
Week 14 
 
16 Weeks / 
End of 
Study 
Informed Consent 
X 
 
 
 
 
 
 
Eligibility Criteria 
X 
 
 
 
 
 
 
Medical History 
X 
 
 
 
 
 
 
Physical Exam 
X 
 
X 
 
X 
 
X 
Vitals 
X 
X1 
X 
X1 
X 
X1 
X 
Height and Weight 
X 
X 
X 
X 
X 
X 
X 
CT/MRI 
X 
 
 
 
 
 
X 
Digital Photography of    
Skin Lesions 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
X 
 
X 
 
X 
 
X 
ECOG  
X 
 
X 
 
X 
 
X 
QOL Questionnaire 
X 
 
X 
 
X 
 
X 
Pregnancy Test 
X 
 
X 
 
X 
 
X 
Chemistries / 
Hematology / UA 
X 
 
X 
 
X 
 
X 
Immunologic Studies2 
X2 
X2 
 
X2 
 
 
 
Concomitant Meds 
X 
 
X 
 
X 
 
X 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
Optional Genomic/ 
Proteomic Molecular 
Sampling5 
X 
 
 
 
 
 
 

NantKwest, Inc.  
 
May 10, 2016 
 
Page 60 of 63 
 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
End of 
Study Visit 
Study Visits 
Visit 1 
Visits 2,3,4,5 
aNK Cycle 1-4 
Visit 6 
Assessment Visit  
Visits 7,8 
aNK Cycles 5-6 
Visit 9 
Assessment Visit  
Visits 10,11 
aNK Cycles 7-8 
 
Visit 12 
Visit Timeframe / 
Window 
- 21 days 
 Day 0 
Week 2 
Week 4 
Week 6 
Week 7 
 
 Week 8 
Week 10    
Week 11 
Week 12 
Week 14 
 
16 Weeks / 
End of 
Study 
Optional Exploratory 
Tumor Biopsy6 
X 
X 
X 
 
X 
 
X 
 aNK Infusion 
 
X 
 
X 
 
X 
 
Disease Progression 
/Tumor Assessment 4 
 
 
X 
 
X 
 
X 
Survival Status 3 
 
 
 
 
 
 
X3 
 
1 - Vital signs will be recorded at 0, 15(+/- 5 minutes), 30(+/- 5 minutes), 60(+/- 15 minutes), 90(+/- 15 minutes) and 120(+/- 30 minutes) from the start of the infusion. 
2 - The development of aNK-specific HLA antibodies and aNK-specific T-Cell response will be evaluated at baseline, 4 weeks and 8 weeks post Cycle 1/Day 2.  The     
4-week sample will be collected prior to the administration of Cycle 3 and the 8-week sample will be collected prior to the administration of Cycle 5. 
3 - Patient will be followed/contacted for survival status monthly until death or lost to follow-up. 
4 - These assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, digital photography, or radiographic imaging (x-ray, 
computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging method 
should be used consistently throughout the study to avoid variability in results. 
5 – Optional exploratory genomics and proteomics molecular profiling will be performed on formalin-fixed, paraffin embedded (FFPE) tumor tissue and whole blood 
(subject matched normal comparator against the tumor tissue) by next-generation sequencing and mass spectrometry-based quantitative proteomics. 
6 – Optional exploratory tumor biopsies may be collected at Baseline, 48-72 hours after completion of Cycle 1 and again at 4 weeks post completion of Cycle 1. 
A tumor biopsy may also be taken at the time of disease progression if pseudo progression needs to be excluded and biopsy analysis may guide in resulting treatment 
decision (see section 8.1.10). 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
Confidential and Proprietary 
1 
 PROTOCOL NUMBER MCC-001 
PHASE II STUDY OF aNK (ACTIVATED NK-92, 
FORMERLY NEUKOPLAST) INFUSIONS IN PATIENTS 
WITH UNRESECTABLE STAGE III (IIIB) OR DISTANT 
METASTATIC (IV) MERKEL CELL CARCINOMA 
(MCC) 
IND Number: 
008,404 
Clinical Study Sponsor: 
NantKwest, Inc. 
2533 South Coast Highway 101 
Suite 210 
Cardiff-by-the-Sea, CA 92007-21333 
Sponsor Contact:  
(For medical questions/emergencies) 
Andreas Niethammer, MD, PhD 
Chief Medical Officer 
Andreas.Niethammer@NantKwest.com 
Sponsor Contact:  
(For study administration, operations, and 
execution questions) 
Saundra Kirven 
Clinical Trial Manager 
Saundra.kirven@NantBio.com 
SAE Reporting: 
Submit SAE Reports to one (1) of the 
following: 
SAE Email: SAE.Reporting@NantBio.com 
Fax: 800-853-3497 
Protocol Version 
Date 
Original Protocol MCC-001 
03 October 2014 
Protocol MCC-001 Amendment 1 
01 November 2014 
Protocol MCC-001 Amendment 2 
01 April, 2015 
Protocol MCC-001 Amendment 3 
20 October, 2015 
Protocol MCC-001 Amendment 4 
10 May, 2016 
Protocol MCC-001 Amendment 5 
28 July 2016 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
2 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
NantKwest, Inc. 
Name of Investigational Product:  
Activated natural killer cells (aNK cells) suspension for injection. 
Name of Active Ingredient: 
aNK cells 
Title of Study:  
Phase II Study of aNK (activated NK-92, formerly Neukoplast) Infusions in Patients with 
Unresectable Stage III (IIIB) or Distant Metastatic (IV) Merkel Cell Carcinoma (MCC) 
Study Number:  
MCC-001 
Study Phase:  
Phase 2 
Primary Objectives:  
• 
Determine the effect of aNK infusions on the 4-month (~16 weeks) progression-free 
survival (PFS) rate in patients with unresectable stage III (IIIB) or distant metastatic 
(stage IV) MCC based on Response Evaluation Criteria in Solid Tumors (RECIST) 
(v1.1). 
Secondary Objectives:  
• 
Determine overall response rate 
• 
Determine time to disease progression 
• 
Determine median overall survival 
• 
Assess the safety and toxicity of aNK 
• 
Assess quality of life (FACT-G) 
Exploratory Objectives: 
• 
To determine the genomic, transcriptomic, and proteomic profile of patients’ tumors to 
identify gene mutations, gene amplifications, RNA-expression levels, and protein-
expression levels.  Correlations between genomic/transcriptomic/proteomic profiles and 
efficacy outcomes will be assessed. 
 
 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
3 
Primary Endpoint: 
• 
4-month PFS rate 
Secondary Endpoints: 
• 
Overall response rate 
• 
Time to disease progression 
• 
Median overall survival 
• 
Safety and toxicity of aNK 
• 
Quality of life assessment (FACT-G) 
Exploratory Endpoints: 
• 
Genomic, transcriptomic, and proteomic profiles and correlations with efficacy 
• 
Potential tumor infiltration by aNK 
Study Design: 
This is a multi-center, non-randomized, open-label, phase II trial to determine the effect of aNK 
infusions in patients with unresectable stage III (IIIB) or distant metastatic (stage IV) MCC.  The 
study will use an adaptive Simon optimal two-stage design.  This two-stage design detects efficacy 
signals, allows for early assessment and avoids enrolling larger numbers of patients in case of 
inefficacy.  In the first stage, up to 12 patients with unresectable stage III (IIIB) or distant metastatic 
(stage IV) MCC were to be enrolled and treated. If the treatment in the first stage improved the 
4-month progression free survival (PFS) rate from 4% to 20% [e.g. at least 1 patient out of 12 patients 
has PFS ≥ 16 weeks (4 months)], then the study would proceed to the second stage, in which 12 more 
patients were planned to be enrolled and treated.  As of July 2016, the trial has met the required 
efficacy signal defined for stage 1 and will continue to enroll a planned total of 24 patients.  In 
addition, there will be a planned Protocol Safety Committee meeting after the first 6 patients are 
enrolled in order to assess the safety of aNK infusions.  aNK will be given via IV infusion at a dose of 
2 x 109 cells/m2 on two consecutive days (= 1 cycle) every 2 weeks for a total of 8 cycles 
(16 infusions). If there is evidence of disease progression believed to be unrelated to an inflammatory 
immune mediated response, at any time point after the fourth cycle, the patient will be withdrawn 
from the trial.  If, at the end of the 8-cycle period, the patient does not have evidence of disease 
progression, unacceptable aNK-related grade 3 or grade 4 adverse events, and, in the opinion of the 
investigator, the patient may benefit from continued therapy, patients may continue to receive study 
treatment according to the dosing schedule until the patient withdraws from the study because of 
reasons outlined in Section 7.2.  Safety and efficacy data will continue to be collected per the 
Schedule of Events. 
Enrollment (planned): 
Approximately 24 patients treated in two consecutive cohorts of 12 patients each. 
 
 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
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Diagnosis and Main Criteria for Inclusion: 
• 
Patients must have histologically confirmed Merkel Cell Carcinoma (MCC) that is 
inoperable Stage III (IIIB) or Stage IV, as defined by the 2010 AJCC staging criteria for 
MCC. Patients with stage IIIB MCC must have been evaluated by a surgical oncologist 
who has documented that their disease is surgically unresectable.  MCC of unknown 
primary is allowed. 
• 
Male or female patients 18 years of age or older.  
• 
Up to two prior systemic cytotoxic chemotherapies and/or novel immunotherapy 
treatments for MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment is 
required. 
• 
ECOG performance status of 0-2. 
• 
Voluntary written informed consent must be given before performance of any study-
related procedure not part of normal medical care, with the understanding that consent 
may be withdrawn by the patient at any time without prejudice to future medical care. 
• 
Adequate cardiac, liver, and kidney function. 
• 
No major surgery within 30 days before study entry. 
Investigational Product, Dosage, and Mode of Administration:  
aNK cells will be provided for clinical administration from a GMP contract manufacturer (CMO).  
The production/expansion (in vitro) of aNK will be according to the standard operating procedures on 
file at the GMP cell processing facility in accordance with CMO procedures and in accordance with 
information contained in BB-IND 8404 entitled “Natural Killer Cell Line, aNK (activated NK-92, 
formerly Neukoplast), Expanded with Interleukin-2 (Novartis)”; IND Sponsor: NantKwest, Inc.   
Duration of Treatment:  
The total duration of planned treatment is approximately 4 months. 
Reference Therapy, Dosage, and Mode of Administration:  
Not applicable. 
Criteria for Evaluation: 
Safety:  
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, changes on 
physical exams, and laboratory values.  All clinically significant findings on any postbaseline tests 
will be reported as AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities.  
Treatment-emergent AEs will be defined as those events with start dates on or after the date of the 
first infusion or events that were present prior to the start of treatment but worsened in severity 
following the first infusion on Cycle 1/Day 1. 
 
 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
5 
Efficacy:  
The 4-month PFS rate will be calculated as the number of patients alive and progression free (based 
on RECIST v1.1) at four months from the date of the first infusion divided by the total number of 
patients.  For purposes of this analysis, the 4-month PFS rate will be calculated, with 4 months based 
on greater than or equal to 112 days (e.g., patients alive and progression-free for at least 112 days will 
be counted in the numerator of the PFS rate calculation). 
Exploratory Molecular Profiling and Analysis and its Rationale:  
Genomic sequencing of tumor cells from tissue relative to non-tumor cells from whole blood will be 
profiled to identify the genomic variances that may contribute to response or disease progression and 
provide an understanding of molecular abnormalities.  RNA sequencing will be conducted to provide 
expression data and give relevance to DNA mutations.  Quantitative proteomics analysis will be 
conducted to determine the exact amounts of specific proteins and to confirm expression of genes that 
are correlative of response and disease progression.  All genomic, transcriptomic, and proteomic 
molecular analyses will be retrospective and exploratory. 
Exploratory Tumor Biopsy: 
To examine possible tumor infiltration by aNK, exploratory tumor biopsies may be collected at 
suitable time points throughout the study in order to capture possible changes in T cell infiltration.  
These optional tumor biopsies may be collected at Baseline, 48-72 hours after completion of Cycle 1, 
and again at 4 weeks post completion of Cycle 1.  A tumor biopsy may also be taken at the time of 
disease progression if pseudo progression needs to be excluded and biopsy analysis may guide in 
resulting treatment decisions.  If a patient decides to undergo extended treatment due to a positive 
clinical response, additional biopsies may be collected at the discretion of the Investigator during this 
period. Per Investigator discretion, tissue should be obtained through either surgical or punch/core 
biopsy methods.  Biopsies that are collected outside of a planned study visit will be captured as an 
unscheduled study visit.  Biopsy samples should be collected and stored and shipped according to the 
MCC-001 Biopsy Collection Guideline. 
Statistical Methods: 
Data analyses will be primarily descriptive in nature.  Continuous variables will be summarized as 
mean, median, standard deviation, minimum and maximum; categorical variables will be summarized 
as the number and percentage of patients in each category.    
All patients receiving one or more infusions will be included in the primary efficacy and safety 
analyses.  Separate efficacy analyses may be performed on the evaluable population, defined as all 
patients receiving all planned doses (8 cycles) per protocol. 
The 4-month PFS rate will be calculated as the number of patients alive and progression free (based 
on RECIST v1.1) at 4 months from the date of first infusion on Cycle 1/Day 1 divided by the total 
number of patients. 
 
 
 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
59 
APPENDIX A. SCHEDULE OF EVENTS 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
End of 
Study 
Visita 
Treatment 
Extension 
Visits 
Study Visits 
Visit 1 
Visits 2, 3, 
4, 5 
aNK Cycle 
1-4 
Visit 6 
Assessment 
Visit  
Visits 7, 8 
aNK Cycles 
5-6 
Visit 9 
Assessment 
Visit  
Visits 10, 11 
aNK Cycles 
7-8 
Visit 12 
 
Visit Timeframe / Window 
-21 days 
Day 1 and 2 
Week 2 
Week 4 
Week 6 
Week 7 
 
Week 8 
Week 10 
Week 11 
Week 12 
Week 14 
 
16 
Weeks / 
End of 
Study 
Every 2 
Weeks 
Following 
Week 12  
Informed consent 
X 
 
 
 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
 
 
 
Medical history 
X 
 
 
 
 
 
 
 
Physical exam 
X 
 
X 
 
X 
 
X 
X 
Vitals 
X 
Xb 
X 
Xb 
X 
Xb 
X 
Xb 
Heightc and Weight 
X 
X 
X 
X 
X 
X 
X 
X 
CT/MRI 
X 
 
 
 
 
 
X 
Xd 
Digital Photography of Skin 
Lesions 
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECG 
X 
 
X 
 
X 
 
X 
X 
ECOG  
X 
 
X 
 
X 
 
X 
X 
QoL questionnaire 
X 
 
X 
 
X 
 
X 
X 
Pregnancy test 
X 
 
X 
 
X 
 
X 
X 
Chemistries / Hematology / UA 
X 
 
X 
 
X 
 
X 
X 
Immunologic studiese 
X 
X 
 
X 
 
 
 
 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
60 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
End of 
Study 
Visita 
Treatment 
Extension 
Visits 
Study Visits 
Visit 1 
Visits 2, 3, 
4, 5 
aNK Cycle 
1-4 
Visit 6 
Assessment 
Visit  
Visits 7, 8 
aNK Cycles 
5-6 
Visit 9 
Assessment 
Visit  
Visits 10, 11 
aNK Cycles 
7-8 
Visit 12 
 
Visit Timeframe / Window 
-21 days 
Day 1 and 2 
Week 2 
Week 4 
Week 6 
Week 7 
 
Week 8 
Week 10 
Week 11 
Week 12 
Week 14 
 
16 
Weeks / 
End of 
Study 
Every 2 
Weeks 
Following 
Week 12  
Concomitant meds 
X 
 
X 
 
X 
 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
Optional 
genomic/transcriptomic/proteomic 
molecular samplingf 
X 
 
 
 
 
 
 
 
Optional exploratory tumor 
biopsyg 
X 
X 
X 
 
X 
 
X 
X 
aNK Infusion 
 
X 
 
X 
 
X 
Xa 
X 
Disease progression /tumor 
assessmenth 
 
 
X 
 
X 
 
X 
X 
Survival statusi 
 
 
 
 
 
 
X 
 
aPatients, who have a positive response to aNK infusions, may elect to have additional infusions after discussion with the Investigator and Medical Monitor.  
Patients may receive additional aNK treatment every 2 weeks, at a dose of 2 x 109 cells/m2.  Treatment may continue until a complete response is achieved or it is 
deemed appropriate by the Investigator and/or NantKwest Medical Monitor. During this extended treatment period the study assessments will be performed 
every 8 weeks as clinically indicated. 
bVital signs will be recorded at 0, 15 (±5 minutes), 30 (±5 minutes), 60 (±15 minutes), 90 (±15 minutes) and 120 (±30 minutes) from the start of the infusion. 
cHeight is recorded at screening only. 
dCT/MRI imaging will be performed at the same intervals as the initial 8-cycle period until the patient has a confirmed CR or confirmed PD.   
eThe development of aNK-specific HLA antibodies and aNK-specific T-Cell response will be evaluated at baseline, 4 weeks and 8 weeks post Cycle 1/Day 2.  
The 4-week sample will be collected prior to the administration of Cycle 3 and the 8-week sample will be collected prior to the administration of Cycle 5. 

aNK 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 5 
 
Confidential and Proprietary 
61 
fOptional exploratory genomic, transcriptomic, and proteomic molecular profiling will be performed on formalin-fixed, paraffin embedded (FFPE) tumor tissue 
and whole blood (patient matched normal comparator against the tumor tissue) by next-generation sequencing and mass spectrometry-based quantitative 
proteomics. 
gOptional exploratory tumor biopsies may be collected at Baseline, 48-72 hours after completion of Cycle 1 and again at 4 weeks post completion of Cycle 1. 
A tumor biopsy may also be taken at the time of disease progression if pseudo progression needs to be excluded and biopsy analysis may guide in 
resulting treatment decision (Section 5.1.10). 
hThese assessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, digital photography, or radiographic imaging (x-ray, 
computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging 
method should be used consistently throughout the study to avoid variability in results. 
iPatient will be followed/contacted for survival status monthly until death or lost to follow-up. 

aNK™
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
PROTOCOL NUMBER MCC-001 
PHASE 2 STUDY OF aNK (ACTIVATED NK-92, 
NATURAL KILLER CELLS) INFUSIONS IN 
COMBINATION WITH ALT-803 (IL-15) IN PATIENTS 
WITH STAGE III (IIIB) OR STAGE IV MERKEL CELL 
CARCINOMA (MCC) 
IND Number: 
008,404 
Clinical Study Sponsor: 
NantKwest, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Andreas Niethammer, MD, PhD 
Chief Medical Officer 
Andreas.Niethammer@NantKwest.com 
SAE Reporting: 
Submit SAE Reports to one of the following: 
SAE Email: SAE.Reporting@NantBio.com 
Fax: 800-853-3497 
Protocol Version 
Date 
Original Protocol MCC-001 
03 October 2014 
Protocol MCC-001 Amendment 1 
01 November 2014 
Protocol MCC-001 Amendment 2 
01 April, 2015 
Protocol MCC-001 Amendment 3 
20 October, 2015 
Protocol MCC-001 Amendment 4 
10 May, 2016 
Protocol MCC-001 Amendment 5 
28 July 2016 
Protocol MCC-001 Amendment 6 
08 September 2016 
Confidential and Proprietary 
1 

aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
NantKwest, Inc. 
Name of Investigational Products:  
aNK™, Suspension for Intravenous Infusion (activated NK-92 cells). 
ALT-803, recombinant human super agonist interleukin-15 (IL-15) complex (also known as 
IL 15N72D:IL-15RαSu/IgG1 Fc complex). 
Name of Active Ingredient: 
Activated NK-92 cells. 
Recombinant human super agonist interleukin-15 (IL-15) complex. 
Title of Study:  
Phase 2 Study of aNK (Activated NK-92 Natural Killer Cells) Infusions in Combination With 
ALT-803 (IL-15) in Patients with Stage III (IIIB) or Stage IV Merkel Cell Carcinoma (MCC). 
Study Number:  
MCC-001 
Study Phase:  
Phase 2 
Primary Objectives:  
• 
Determine the effect of aNK intravenous (IV) infusions in combination with ALT-803 on 
the 4-month (~16 weeks) progression-free survival (PFS) rate in patients with stage III 
(IIIB) or stage IV MCC based on Response Evaluation Criteria in Solid Tumors 
(RECIST Version 1.1). 
Secondary Objectives:  
• 
Determine overall response rate (ORR). 
• 
Determine time to disease progression (TTP). 
• 
Determine overall survival (OS). 
• 
Assess the safety and tolerability of the combination of aNK and ALT-803. 
• 
Assess quality of life (FACT-G). 
Exploratory Objectives: 
• 
To determine the genomic, transcriptomic, and proteomic profile of patients’ tumors to 
identify gene mutations, gene amplifications, RNA-expression levels, and protein-
expression levels.  Correlations between genomic, transcriptomic, and proteomic profiles 
and efficacy outcomes will be assessed. 
 
 
Confidential and Proprietary 
2 

aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
Primary Endpoint: 
• 
4-month PFS rate. 
Secondary Endpoints: 
• 
ORR. 
• 
TTP. 
• 
OS. 
• 
Safety and tolerability of the combination of aNK plus ALT-803. 
• 
Quality of life assessment (FACT-G). 
Exploratory Endpoints: 
• 
Genomic, transcriptomic, and proteomic profiles and correlations with efficacy. 
• 
Immune cell quantification in the tumor microenvironment. 
Study Design: 
This is a multi-center, non-randomized, open-label, phase 2 trial to determine the effects of aNK in 
combination with ALT-803 in patients with stage III (IIIB) or stage IV MCC.  The study will use an 
adaptive Simon optimal two-stage design, which detects efficacy signals, allows for early assessment, 
and avoids enrolling larger numbers of patients in case of inefficacy.   
In the original protocol, an initial cohort of up to 12 patients with stage III (IIIB) or stage IV MCC 
were to be enrolled and treated with aNK monotherapy (first stage).  If the treatment in the first stage 
improved the 4-month progression free survival (PFS) rate from 4% to 20% (e.g. at least 1 patient out 
of 12 patients has PFS ≥ 16 weeks [4 months]), then the study would proceed to the second stage, in 
which 12 more patients were planned to be enrolled and treated.  As of July 2016, the trial has met the 
required efficacy signal defined for the first stage and will continue to enroll a planned total of 
24 patients who will receive the combination of aNK and ALT-803.  Any patients who are already 
receiving aNK cells as monotherapy will receive aNK cells in combination with ALT-803 in 
subsequent cycles.  
As of 08 September 2016, the protocol has been amended to include ALT-803 in combination with 
aNK.  There will be a planned Safety Review Committee meeting after 6 patients have received at 
least 2 cycles of aNK in combination with ALT-803.   
aNK will be given via IV infusion at a dose of 2 x 109 cells/m2 on two consecutive days (= 1 cycle) 
every 2 weeks.  In addition, ALT-803 will be administered SC at 10 μg/kg on the first day of every 
aNK infusion (before the aNK infusion) every 2 weeks. 
If there is evidence of disease progression at any time point after the sixth cycle and it is believed to 
be unrelated to an inflammatory immune-mediated response, the patient will be withdrawn from the 
trial.  If, at the end of the 8-cycle period, the patient does not have evidence of disease progression, 
unacceptable aNK-related and/or ALT-803-related grade 3 or grade 4 adverse events, and, in the 
opinion of the investigator, the patient may benefit from continued therapy, patients may continue to 
receive study treatment according to the dosing schedule until the patient withdraws from the study 
because of reasons outlined in Section 7.7.  Safety and efficacy data will continue to be collected per 
Confidential and Proprietary 
3 

aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
the Schedule of Events. 
Enrollment (planned): 
Approximately 24 patients. 
Diagnosis and Main Criteria for Inclusion: 
• 
Patients must have histologically confirmed MCC that is Stage III (IIIB) or Stage IV, as 
defined by the 2010 AJCC staging criteria for MCC.  MCC of unknown primary is 
allowed. 
• 
Male or female patients 18 years of age or older.  
• 
Prior systemic cytotoxic chemotherapies and/or novel immunotherapy treatments for 
MCC are allowed. A wash-out period of 2 weeks prior to aNK treatment is required. 
• 
ECOG performance status of 0-2. 
• 
Voluntary written informed consent must be given before performance of any study-
related procedure not part of normal medical care, with the understanding that consent 
may be withdrawn by the patient at any time without prejudice to future medical care. 
• 
Mandatory diagnostic biopsy and whole blood sample are required.  
• 
Adequate cardiac, liver, and kidney function. 
• 
No major surgery within 30 days before study entry. 
Investigational Product, Dosage, and Mode of Administration:  
aNK cells will be provided for clinical administration from a GMP Contract Manufacturing 
Organization (CMO).  The production/expansion (in vitro) of aNK will be according to the standard 
operating procedures on file at the GMP cell processing facility in accordance with CMO procedures 
and in accordance with information contained in BB-IND 8404 entitled “Natural Killer Cell Line, 
aNK (activated NK-92, formerly Neukoplast), Expanded with Interleukin-2 (Novartis)”; IND 
Sponsor: NantKwest, Inc.   
aNK will be given via IV infusion at a dose of 2 x 109 cells/m2 on two consecutive days (= 1 cycle) 
every 2 weeks.   
ALT-803 will be administered SC at 10 μg/kg on the first day of every aNK infusion (before the aNK 
infusion) every 2 weeks.  Injection sites should be rotated per institutional guidelines and each 
injection site separated by at least 1 inch. 
Duration of Treatment:  
Patients will receive experimental treatment until they experience progressive disease or unacceptable 
toxicity, withdraw consent, or if the investigator feels it is no longer in their best interest to continue 
treatment.  Experimental treatment will be administered for a minimum of 8 cycles, unless the patient 
dies or there is a clinical necessity to terminate treatment.  Treatment will continue for a maximum of 
1 year under this protocol or until confirmed disease progression, whichever happens first. 
If there is evidence of disease progression at any time point after the sixth cycle and it is believed to 
be unrelated to an inflammatory immune-mediated response, the patient will be withdrawn from the 
trial. 
Confidential and Proprietary 
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aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
Reference Therapy, Dosage, and Mode of Administration:  
Not applicable. 
Criteria for Evaluation: 
Safety:  
Safety and toxicity will be assessed through the analysis of AEs, ECGs, vital signs, changes on 
physical exams, and laboratory values.  All clinically significant findings on any postbaseline tests 
will be reported as AEs. AEs will be coded using the Medical Dictionary for Regulatory Activities 
(MedDRA).  Treatment-emergent AEs will be defined as those events with start dates on or after the 
date of the first infusion or events that were present prior to the start of treatment but worsened in 
severity following the first infusion on cycle 1/day 1. 
Efficacy:  
The 4-month PFS rate will be calculated as the number of patients alive and progression free (based 
on RECIST v1.1) at four months from the date of the first infusion divided by the total number of 
patients.  For purposes of this analysis, the 4-month PFS rate will be calculated based on 4 months 
being greater than or equal to 112 days (e.g., patients alive and progression-free for at least 112 days 
will be counted in the numerator of the PFS rate calculation).  ORR, TTP, and OS will also be 
assessed.  
Exploratory Molecular Profiling and Analysis and its Rationale:  
Genomic sequencing of tumor cells from tissue relative to non-tumor cells from whole blood will be 
profiled to identify the genomic variances that may contribute to response or disease progression and 
provide an understanding of molecular abnormalities.  RNA sequencing will be conducted to provide 
expression data and give relevance to DNA mutations.  Quantitative proteomics analysis will be 
conducted to determine the exact amounts of specific proteins and to confirm expression of genes that 
are correlative of response and disease progression.  All genomic, transcriptomic, and proteomic 
molecular analyses will be retrospective and exploratory. 
Exploratory Tumor Biopsy: 
To examine possible tumor infiltration by aNK cells as well as other immune cells, including but not 
limited to autologous NK cells, T cells, and myeloid-derived suppressor cells, exploratory tumor 
biopsies may be collected at any time point as clinically indicated.  Tumor biopsies may also be taken 
at the time of disease progression if pseudo-progression (progression on imaging due to infiltration by 
inflammation-related immune cells) needs to be excluded and if biopsy analysis may guide treatment 
decisions.   
Statistical Methods: 
Data analyses will be primarily descriptive in nature.  Continuous variables will be summarized as 
mean, median, standard deviation, minimum and maximum; categorical variables will be summarized 
as the number and percentage of patients in each category.    
All patients receiving aNK or ALT-803 will be included in the efficacy and safety analyses.  Patients 
who only received aNK cells as monotherapy will be summarized separately from patients who 
Confidential and Proprietary 
5 

aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
received aNK plus ALT-803 combination therapy.   
The 4-month PFS rate will be calculated as the number of patients alive and progression free (based 
on RECIST v1.1) at 4 months from the date of first infusion on cycle 1/day 1 divided by the total 
number of subjects.  The 95% confidence intervals for the 4-month PFS response rate will also be 
presented.  The ORR and its 95% confidence interval will be presented.  TTP and OS will be 
analyzed using Kaplan-Meier methods. 
 
 
 
Confidential and Proprietary 
6 

aNK™
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
Table 6: 
Schedule of Events 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
Week 
16a 
Treatment 
Extension 
Visits 
Study Visits 
Visit 1 
Visits 2, 3, 
4, 5 
aNK Cycle 
1-4
Visit 6 
Assessment 
Visit 
Visits 7, 8 
aNK Cycles 
5-6
Visit 9 
Assessment 
Visit 
Visits 10, 11 
aNK Cycles 
7-8
Visit 12 
Study Week 
Up to -21 
Days 
Week 0 
Week 2 
Week 4 
Week 6 
Week 7 
Week 8 
Week 10 
Week 11 
Week 12 
Week 14 
16 
Weeks 
Every 2 
Weeks 
Following 
Visit 12 
Informed consent 
X 
Eligibility criteria 
X 
Medical history 
X 
Physical exam 
X 
X 
X 
X 
X 
Vitalsb 
X 
X 
X
X 
X 
X 
X 
X 
Heightc and weight 
X 
X 
X 
X 
X 
X 
X 
X 
CT/MRId 
X 
X 
X 
Digital photography of skin 
lesions
X 
X 
X 
X 
X 
X 
X 
X 
12-lead ECGe
X 
X 
X 
X 
X 
X 
X 
X 
ECOG 
X 
X 
X 
X 
X 
X 
X 
X 
FACT-G QoL questionnairee 
X 
X 
X 
X 
X 
Pregnancy test (WOCBP) 
X 
X 
X 
X 
X 
X 
X 
X 
Clinical laboratory tests 
X
X 
X 
X 
X 
X 
X 
X 
Immunologic studiesf 
X
X 
X
X 
X 
Confidential and Proprietary 
45 

aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
Study Period 
Screening/ 
Baseline 
Treatment Visits 
Week 
16a 
Treatment 
Extension 
Visits 
Study Visits 
Visit 1 
Visits 2, 3, 
4, 5 
aNK Cycle 
1-4 
Visit 6 
Assessment 
Visit  
Visits 7, 8 
aNK Cycles 
5-6 
Visit 9 
Assessment 
Visit  
Visits 10, 11 
aNK Cycles 
7-8 
Visit 12 
 
Study Week 
Up to -21 
Days 
Week 0 
Week 2 
Week 4 
Week 6 
Week 7 
 
Week 8 
Week 10 
Week 11 
Week 12 
Week 14 
 
16 
Weeks 
Every 2 
Weeks 
Following 
Visit 12  
Concomitant medications 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse events 
 
X 
X 
X 
X 
X 
X 
X 
Mandatory 
genomic/transcriptomic/proteomic 
molecular samplingg 
X 
 
 
 
 
 
 
 
Optional exploratory tumor 
biopsyh 
 
X 
X 
 
X 
 
X 
X 
aNK infusioni 
 
X 
 
X 
 
X 
Xa 
X 
ALT-803 administrationj 
 
X 
 
X 
 
X 
X 
Xa 
Disease progression /tumor 
assessmentk 
X 
 
X 
 
X 
 
X 
X 
Survival statusl 
 
 
 
 
 
 
X 
 
aPatients who have a positive response to treatment with aNK plus ALT-803 may be provided the opportunity to continue additional treatment after discussion 
with the Investigator and Sponsor Medical Monitor.  Patients may receive additional aNK plus ALT-803 treatment every 2 weeks at a dose of 2 x 109 cells/m2.  
Treatment may continue until a complete response is achieved or it is deemed appropriate by the Investigator and/or Sponsor Medical Monitor. 
bVital signs will be recorded at 0, 15 (±5 minutes), 30 (±5 minutes), 60 (±15 minutes), 90 (±15 minutes) and 120 (±30 minutes) minutes from the start of the 
infusion. 
cHeight is recorded at screening only. 
dCT/MRI imaging will be performed at the same intervals as the initial 8-cycle period until the patient has a confirmed CR or confirmed PD.   
eECGs will be performed at 6-week intervals during treatment extension. 
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aNK™ 
NantKwest, Inc. 
Clinical Trial Protocol: MCC-001 Amendment 6 
 
fThe development of aNK-specific HLA antibodies and aNK-specific T-Cell response will be evaluated at baseline, 4 weeks, and 8, 10, 11, and 12 weeks post 
cycle 1/day 2.  The 4-week sample will be collected prior to the administration of cycle 3, the 8-week sample will be collected prior to the administration of cycle 
5, the 10-week sample will be collected prior to the administration of cycle 6, the 11-week sample will be collected during the visit 9 assessment visit, and the 
12-week sample will be collected prior to the administration of cycle 7. 
gMandatory exploratory genomic, transcriptomic, and proteomic molecular profiling will be performed on formalin-fixed, paraffin embedded (FFPE) tumor 
tissue and whole blood (patient matched-normal comparator against the tumor tissue) by next-generation sequencing and mass spectrometry-based quantitative 
proteomics. 
hOptional exploratory tumor biopsies may be collected at any time point as clinically indicated.  A tumor biopsy may also be taken at the time of disease 
progression if pseudo-progression needs to be excluded and if biopsy analysis may guide in resulting treatment decision (Section 6.17). 
iaNK cells are administered day 1 and day 2 every 2 weeks (1 cycle).  
jALT-803 is administered SC on each day-1 aNK infusion, before the aNK infusion, every 2 weeks. 
kAssessments may include bi-dimensional measurement of disease lesions by palpation, clinical exam, digital photography, or radiographic imaging (x-ray, 
computed tomography [CT] scan, positron emission tomography [PET] scan, magnetic resonance imaging [MRI], or ultrasound).  The same radiologic imaging 
method should be used consistently throughout the study to avoid variability in results. 
lPatient will be contacted monthly by site staff via telephone to obtain disease progression and survival status.  Contacts will be continued until death or lost to 
follow-up. 
 
 
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