A Pharmacokinetic Sub-Study of QUILT-3.032 (CA ALT-803-01-16): A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer and QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer
Conditions: Pharmacokinetics
Sponsor: Altor BioScience

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc 
16.1.1 Protocol QUILT-3.032-PK
ALT-803 
Confidential 
Page 1 of 36
DRUG: 
ALT-803 (also known as N-803) 
STUDY NUMBER(S): 
QUILT-3.032-PK 
PROTOCOL(S) TITLE: 
A Pharmacokinetic Sub-Study of QUILT-3.032 
(CA-ALT-803-01-16): A Multicenter Clinical Trial of 
Intravesical Bacillus Calmette-Guerin (BCG) in 
Combination with ALT-803 in Patients with BCG 
Unresponsive High Grade Non-Muscle Invasive 
Bladder Cancer 
IND NUMBER: 
121976 
SPONSOR: 
Altor BioScience, LLC, a wholly-owned subsidiary of 
NantCell, Inc.  (Altor BioScience) 
ORIGINAL PROTOCOL DATE: 
10 June 2019 
VERSION NUMBER: 
1.0 
VERSION DATE: 
10 June 2019 

Altor BioScience, LLC, a wholly-owned subsidiary ofNantCell, Inc 
ALT-803 
16.1.l Protocol QUILT-3.032-PK 
CLINICAL PROTOCOL APPROVAL FORM 
Protocol Title: A Pharmacokinetic Sub-Study ofQUIL T-3.032: A Multicenter Clinical Trial of lntravesical 
Bacillus Calmette-Guerin (BCG) in Combination with ALT-803 in Patients with BCG Unresponsive High 
Grade Non-Muscle Invasive Bladder Cancer 
Study No: QUILT-3.032-PK 
Original Protocol Date: l 0 June 2019 
Protocol Version No: 1.0 
Protocol Version Date: 10 June 2019 
This study protocol was subject to critical review and has been approved by the appropriate 
protocol review committee of the Sponsor. The information contained in this protocol is consistent 
with: 
• 
The current risk-benefit evaluation of the investigational product. 
• 
The moral, ethical and scientific principles governing clinical research as set out in the 
Declaration of Helsinki, and principles of GCP as described in 21 CFR parts 50, 54, 56 and 
312 and according to applicable local requirements. 
The Investigator will be supplied with details of any significant or new findings, including adverse 
events, relatin to treatment with the investi ational roduct. 
Name and Title 
Clinical Development: 
Amy Rock, PhD 
Vice-President, Clinical Development & 
Regulatory Affairs 
Medical Lead: 
John Lee, MD 
Senior Vice-President, Adult Medical Affairs 
Regulatory Affairs: 
Melissa Luras 
Associate Director, Regulatory Affairs 
Col'!fidential 
Signature 
Date 
Page 2 of36 

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc  
16.1.1 Protocol QUILT-3.032-PK
ALT-803 
 
 
Confidential 
Page 4 of 36
 
STUDY SYNOPSIS 
Title:  
A Pharmacokinetic Sub-Study of QUILT-3.032: A Multicenter Clinical Trial 
of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with 
ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle 
Invasive Bladder Cancer 
 
Rationale:  
ALT-803 is an IL-15-based immunostimulatory protein complex that acts as a 
growth and activation factor for natural killer (NK) cells and effector and 
memory T cells. Based on the results of animal tumor models, ALT-803 
stimulated cellular immune responses are expected to exhibit potent activity 
against human tumor cells. The objective of this study is to establish the 
pharmacokinetic (PK) profile of intravesical ALT-803 administered to patients 
with BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer 
(NMIBC). 
 
Target 
Population: 
Adult Patients with BCG Unresponsive High Grade Non-Muscle Invasive 
Bladder Cancer  
 
Number of 
Subjects: 
12 - 20 subjects 
 
 
Objectives:  
Primary  
To determine the PK profile of ALT-803 after single dose intravesical 
instillation of 400 µg ALT-803 plus BCG  
 
Secondary  
To determine the PK profile of ALT-803 after multiple intravesical 
instillations of 400 µg ALT-803 plus BCG 
 
Study Design: Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) 
 
QUILT-3.032 (CA-ALT-803-01-16): Phase 2, open-label, single-arm, 
two-cohort, multicenter study of intravesical BCG plus ALT-803 (400 µg) in 
patients with BCG unresponsive high grade NMIBC.  Patients will be enrolled 
into one of two study cohorts. Cohort A will enroll 80 patients who have 
histologically confirmed presence of BCG-unresponsive carcinoma in situ 
(CIS) [with or without Ta/T1 papillary disease]. Cohort B will enroll 
80 patients who have histologically confirmed BCG-unresponsive high-grade 
Ta/T1 papillary disease. Cohort A and B are two independent study cohorts 
and will be separately evaluated for efficacy and safety. The study will be 
conducted in conformity with Good Clinical Practice (GCP). All patients 
treated in the study will receive via a urinary catheter in the bladder ALT-803 
plus BCG, weekly for 6 consecutive weeks during the induction treatment 
period.  
 

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc  
16.1.1 Protocol QUILT-3.032-PK
ALT-803 
 
 
Confidential 
Page 5 of 36
 
PK sub-study: Blood samples to determine serum levels of ALT-803 will be 
collected on study day 1 prior to dosing, and at post-bladder voiding 
(± 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after 
dosing administered at study Week 1 and again at the same time points for 
study Week 6. Six subjects from cohort A and six subjects from cohort B will 
be sampled initially. Up to an additional 4 subjects from each cohort may also 
be sampled. 
 
Primary 
Endpoints:  
Serum concentration will be used to calculate the following PK 
parameters:  
• 
half-life (t½) 
• 
apparent (extravascular) volume of distribution (Vz/F) 
• 
apparent (extravascular) clearance (CL/F) 
• 
maximum observed concentration (Cmax) 
• 
time of the observed maximum concentration (Tmax) 
• 
area under the plasma concentration curve from time 0 through the 
last measurable concentration (AUC0-t) 
• 
area under the plasma concentration curve from time 0 extrapolated 
to infinite time (AUC0-inf) 
 
 

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc  
16.1.1 Protocol QUILT-3.032-PK 
ALT-803 
 
 
Confidential 
Page 6 of 36
 
STUDY SCHEMATIC 

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc  
16.1.1 Protocol QUILT-3.032-PK
ALT-803 
 
 
Confidential 
Page 19 of 36
 
10 STATISTICS 
10.1 
GENERAL PROCEDURES 
A separate, detailed PK Analysis Plan will be developed for data analysis prior to study completion 
and data lock.  Descriptive statistical methods will be used to summarize the data from this study.  
Unless otherwise stated, the term descriptive statistics refers to the number of subjects, mean, 
median, standard deviation, minimum, and maximum for continuous data, and frequencies and 
percentages for categorical data. No statistical testing will be performed. Results will be 
summarized in the final clinical study report for QUILT-3.032 
10.2 
SAMPLE SIZE 
Six subjects from Cohort A and six subjects from Cohort B will be sampled initially. Up to an 
additional 4 subjects from each cohort may also be sampled.  The maximum number of subjects 
enrolled will be 20. 
10.3 
PK ASSAY DESCRIPTION 
The method used to detect and quantify serum IL-15 employs a Human IL-15 assay kit, supplied 
by R&D Systems (Minneapolis, MN). The specific assay utilized comprises a sandwich ELISA 
(enzyme-linked immunosorbent assay) employing two unique anti-human IL-15 monoclonal 
antibodies 
10.4 
PK PARAMETER ANALYSIS  
The following PK parameters will be calculated from the serum concentration-time data by 
noncompartmental analysis (NCA) with Phoenix™ WinNonlin® Version 8.0 or higher 
(WinNonlin; Certara, Inc., Mountain View, California), using an extravascular administration 
model (as feasible):  
• Apparent half-life (t½) 
• apparent (extravascular) volume of distribution (Vz/F) 
• apparent (extravascular) clearance (CL/F) 
• maximum observed concentration (Cmax) 
• time of the observed maximum concentration (Tmax) 
• area under the plasma concentration curve from time 0 through the last measurable 
concentration (AUC0-t) 
• area under the plasma concentration curve from time 0 extrapolated to infinite time 
(AUC0-inf or AUC0-∞) 

Altor BioScience, LLC, a wholly-owned subsidiary of NantCell, Inc  
16.1.1 Protocol QUILT-3.032-PK
ALT-803 
 
 
Confidential 
Page 20 of 36
 
The actual sampling times and nominal doses will be used in the analysis. Prior to Tmax, N-803 
concentrations that are BLQ (< 23.4 pg/mL) will be set to 0; BLQ concentrations after Tmax will 
be excluded from the analysis. Concentrations reported as “0” will be converted to BLQs prior to 
analysis. 
The area under the curve from time zero to the last measurable concentration (AUC0-t) will be 
calculated using the linear up/log down method. Log/linear regression through the last three or 
more time points (excluding Tmax) will be used to estimate the elimination constant (λz). The 
terminal phase half-life (t1/2) and the AUC from time zero to infinity (AUC0-inf or AUC0-∞) will be 
calculated using the following equations: 
t1/2 = ln (2)/λz 
AUC0-inf = AUC0-t + Ct,pred/ λz, 
where Ct,pred is the last predicted concentration based on the exponential decline (eg, e-λz·t). If any 
of the following are observed, the terminal phase-dependent parameters (eg, λz, t1/2, AUC0-inf, CL/F, 
Vz/F) following single dose administration will not be reported: 
• λz indicates a positive slope (λz>0) 
• Tmax is one of the last three time points with measurable concentrations 
• the linear regression coefficient or the goodness of fit (R2) is less than 0.80 
When the extrapolated area (eg, Ct,pred/λz or AUC Extrap.) is greater than 20% of total AUC0-inf, 
this suggests that there may be greater uncertainty in PK parameters dependent on the definition 
of the terminal phase and/or this extrapolation (eg, λz, t1/2, AUC0-inf, CL/F, Vz/F).   
No statistical comparisons will be performed for the PK parameters. All PK parameters will be 
analyzed descriptively including mean,  standard deviation, minimum, median, maximum and 
%CV,  as applicable. 
 
 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc 
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
Confidential 
Page 1 of 32
DRUG: 
ALT-803 (also known as N-803) 
STUDY NUMBER(S): 
QUILT-3.032-2.005-PK 
PROTOCOL(S) TITLE: 
A Pharmacokinetic Sub-Study of QUILT-3.032 
(CA-ALT-803-01-16): A Multicenter Clinical Trial of 
Intravesical Bacillus Calmette-Guerin (BCG) in 
Combination with ALT-803 in Patients with BCG 
Unresponsive High Grade Non-Muscle Invasive 
Bladder Cancer and QUILT-2.005: A Study of 
Intravesical BCG in Combination With ALT-803 in 
Patients With Non-Muscle Invasive Bladder Cancer 
IND NUMBER: 
121976 
SPONSOR: 
Altor BioScience, LLC, a wholly-owned subsidiary of 
ImmunityBio, Inc. (Altor BioScience) 
ORIGINAL PROTOCOL DATE: 
10 June 2019 
VERSION NUMBER: 
2.0 
VERSION DATE: 
24 February 2020 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 4 of 32
 
STUDY SYNOPSIS 
Title:  
A Pharmacokinetic Sub-Study of QUILT-3.032: A Multicenter Clinical Trial 
of Intravesical Bacillus Calmette-Guerin (BCG) in Combination with 
ALT-803 in Patients with BCG Unresponsive High Grade Non-Muscle 
Invasive Bladder Cancer and QUILT-2.005: A Study of Intravesical BCG in 
Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder 
Cancer 
 
Rationale:  
ALT-803 is an IL-15-based immunostimulatory protein complex that acts as a 
growth and activation factor for natural killer (NK) cells and effector and 
memory T cells. Based on the results of animal tumor models, ALT-803 
stimulated cellular immune responses are expected to exhibit potent activity 
against human tumor cells. The objective of this study is to establish the 
pharmacokinetic (PK) profile of intravesical ALT-803 administered to patients 
with High Grade Non-Muscle Invasive Bladder Cancer (NMIBC). 
 
Target 
Population: 
Adult Patients with High Grade Non-Muscle Invasive Bladder Cancer  
 
Number of 
Subjects: 
12 - 20 subjects 
 
 
Objectives:  
Primary  
To determine the PK profile of ALT-803 after single dose intravesical 
instillation of 400 µg ALT-803   
 
Secondary  
To determine the PK profile of ALT-803 after multiple intravesical 
instillations of 400 µg ALT-803  
 
Study Design: Non-interventional PK sub-study of QUILT-3.032 (CA-ALT-803-01-16) and 
QUILT-2.005 (CA-ALT-803-01-14) 
 
QUILT-3.032 (CA-ALT-803-01-16): Phase 2, open-label, single-arm, 
three-cohort, multicenter study of intravesical BCG plus ALT-803 (400 µg) in 
patients with BCG unresponsive high grade NMIBC.  Patients will be enrolled 
into one of three study cohorts. Cohort A will enroll 80 patients who have 
histologically confirmed presence of BCG-unresponsive carcinoma in situ 
(CIS) [with or without Ta/T1 papillary disease]. Cohort B will enroll 
80 patients who have histologically confirmed BCG-unresponsive high-grade 
Ta/T1 papillary disease. Cohort C will enroll up to 23 patients who also have 
histologically confirmed presence of BCG-unresponsive CIS [with or without 
Ta/T1 papillary disease]. Patients in Cohorts A and B will receive ALT-803 
plus BCG combination treatment. Patients in Cohort C will receive ALT-803 
alone. Enrollment of Cohort C will start once the enrollment of Cohort A is 
complete. Cohorts A, B, and C are independent study cohorts and will be 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 5 of 32
 
separately evaluated for efficacy and safety. The study will be conducted in 
conformity with Good Clinical Practice (GCP). All patients treated in the study 
will receive via a urinary catheter in the bladder ALT-803 plus BCG or ALT-
803 alone, weekly for 6 consecutive weeks during the induction treatment 
period.  
QUILT-2.005 (CA-ALT-01-14): This is a phase 2b, randomized, two-cohort, 
open-label, multicenter study of intravesical ALT-803 plus BCG versus BCG 
alone, in BCG naïve patients with high-grade NMIBC. Patients will be 
enrolled into one of two study cohorts and randomized into two arms to be 
treated with either ALT-803 plus BCG or BCG alone. Cohort A will initially 
enroll 366 patients who have histologically confirmed CIS (with or without 
Ta/T1 papillary disease). Cohort B will initially enroll 230 patients who have 
histologically confirmed high-grade papillary Ta/T1 disease only. Cohorts A 
and B are two independent study cohorts and will be evaluated separately for 
efficacy. 
 
PK sub-study: Blood samples to determine serum levels of ALT-803 will be 
collected on study day 1 prior to dosing, and at post-bladder voiding 
(+ 15 minutes), 24 (±2), 48 (±4), 72 (±4), 96 (±4) and 168 (±4) hours after 
dosing administered at study Week 1 and again at the same time points for 
study Week 6. Six subjects from either cohort A (either study) or cohort C 
(QUILT 3.032) and six subjects from cohort B (either study) will be sampled 
initially. Up to an additional 4 subjects for each cohort may also be sampled. 
Patients enrolled in QUILT 2.005 must have been randomized to receive ALT-
803 plus BCG to be eligible for the PK sub-study.  
 
 
Primary 
Endpoints:  
Serum concentration will be used to calculate the following PK 
parameters:  
• 
half-life (t½) 
• 
apparent (extravascular) volume of distribution (Vz/F) 
• 
apparent (extravascular) clearance (CL/F) 
• 
maximum observed concentration (Cmax) 
• 
time of the observed maximum concentration (Tmax) 
• 
area under the plasma concentration curve from time 0 through the 
last measurable concentration (AUC0-t) 
• 
area under the plasma concentration curve from time 0 extrapolated 
to infinite time (AUC0-inf) 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 13 of 32
 
STUDY SCHEMATIC: QUILT-3.032 
 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 14 of 32
 
STUDY SCHEMATIC: QUILT-2.005 
 

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 15 of 32
 
4.2 
SCHEDULE OF ASSESSMENTS 
 
Table 2: 
Schedule of Assessments 
 
TESTS & PROCEDURES
Screen
Study Week
2
3
4
5
7
Study Day
1
2
3
4
5
6
7
8
15
22
29
36
37
38
39
40
41
42
43
Blood sampling for ALT-803 PK*
X
X
X
X
X
X**
X
X
X
X
X
X**
Initial (Induction) Treatment Period
1
6
*Blood sampling for PK will be collected prior to ALT-803 dose and at post-bladder voiding (+15 minutes), 24 (±2 hours), 48 (±4 hours), 72 (±4 hours), 96 (±4 hours) and 168 (±4 hours) 
hours after dosing administered at weeks 1 and 6.
**Pre-dose only.

Altor BioScience, LLC, a wholly-owned subsidiary of ImmunityBio, Inc  
ALT-803
16.1.1 Protocol QUILT-3.032-2.005-PK  
 
 
Confidential 
Page 19 of 32
 
10 STATISTICS 
10.1 
GENERAL PROCEDURES 
A separate, detailed PK Analysis Plan will be developed for data analysis prior to study completion 
and data lock.  Descriptive statistical methods will be used to summarize the data from this study. 
Unless otherwise stated, the term descriptive statistics refers to the number of subjects, mean, 
median, standard deviation, minimum, and maximum for continuous data, and frequencies and 
percentages for categorical data. No statistical testing will be performed. Results will be 
summarized in the final clinical study reports for QUILT-3.032 and QUILT 2.005. 
10.2 
SAMPLE SIZE 
Six subjects from Cohort A and six subjects from Cohort B will be sampled initially. Up to an 
additional 4 subjects from each cohort may also be sampled.  The maximum number of subjects 
enrolled will be 20. 
10.3 
PK ASSAY DESCRIPTION 
The method used to detect and quantify serum IL-15 employs a Human IL-15 assay kit, supplied 
by R&D Systems (Minneapolis, MN). The specific assay utilized comprises a sandwich ELISA 
(enzyme-linked immunosorbent assay) employing two unique anti-human IL-15 monoclonal 
antibodies 
10.4 
PK PARAMETER ANALYSIS  
The following PK parameters will be calculated from the serum concentration-time data by 
noncompartmental analysis (NCA) with Phoenix™ WinNonlin® Version 8.0 or higher 
(WinNonlin; Certara, Inc., Mountain View, California), using an extravascular administration 
model (as feasible):  
• Apparent half-life (t½) 
• apparent (extravascular) volume of distribution (Vz/F) 
• apparent (extravascular) clearance (CL/F) 
• maximum observed concentration (Cmax) 
• time of the observed maximum concentration (Tmax) 
• area under the plasma concentration curve from time 0 through the last measurable 
concentration (AUC0-t) 
• area under the plasma concentration curve from time 0 extrapolated to infinite time 
(AUC0-inf or AUC0-∞)