Clinical trial NCT04927884
Conditions: Advanced Triple Negative Breast Cancer
Keywords: Chemoimmunotherapy Stage IV TNBC Sacituzumab N-803 PD-L1 t-haNK Cyclophosphamide
Sponsor: ImmunityBio, Inc.
Start date: 2021-09-08; Completion date: 2022-12-12
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects with Triple Negative Breast Cancer (TNBC) after at least 2 prior treatments for metastatic disease.

Detailed description:
In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be assessed for dose limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as follows:

* Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV)
* Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV)
* Dose level 1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV)

In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into phase 2 should proceed.

In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of Simon's two stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will proceed to the second stage.

If the study proceeds to the second stage, an additional 41 subjects will be enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed response, the combination therapy will be considered for further development.

All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles.

Arms: arm 1: Sacituzumab plus chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK)
Interventions: intervention 1: N-803 intervention 2: PD-L1 t-haNK intervention 3: Sacituzumab Govitecan-Hziy intervention 4: Cyclophosphamide
Intervention descriptions: intervention 1: Dose: 15 μg/kg subcutaneously (SC)

Frequency: administered on Day 8 of each cycle (every 3 weeks) intervention 2: Dose: \~2 × 10\^9 cells intravenously (IV)

Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks) intervention 3: Phase 1b:

Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV)

Phase 2: Dose based on Phase 1b Recommended Phase 2 Dose (IV)

Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks) intervention 4: Dose: 25 mg capsules taken twice per day by mouth (PO)

Frequency: to be taken Days 1-15 and 15-19 of each cycle (every 3 weeks)

Protocol documents:
Prot_SAP_000.pdf: 
N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 
 
Confidential and Proprietary 
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TITLE PAGE 
OPEN-LABEL PHASE 1B/2/3 TRIAL OF SACITUZUMAB 
GOVITECAN-HZIY PLUS CHEMOIMMUNOTHERAPY 
FOR THE TREATMENT OF SUBJECTS WITH 
ADVANCED TRIPLE-NEGATIVE BREAST CANCER 
AFTER PRIOR THERAPY 
 
Study Number: 
QUILT-3.058 
IND Sponsor: 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Sandeep Bobby Reddy, MD 
Chief Medical Officer,  
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: Bobby.Reddy@ImmunityBio.com 
Cell Phone: +1-562-631-4945 
 
Protocol Version 
Date 
Version 1 
15 March 2021 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 
 
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STATEMENT OF COMPLIANCE 
This trial will be conducted in accordance with Good Clinical Practice (GCP) as described in the 
International Conference on Harmonization (ICH) Guideline for GCP E6(R2) and in accordance 
with United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 
CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) and the general ethical 
principles outlined in the Declaration of Helsinki. The study will receive approval from an 
Institutional Review Board (IRB) prior to commencement. The Principal Investigator will assure 
that no deviation from, or changes to the protocol will take place without prior agreement from 
the sponsor and documented approval from the IRB, except where necessary to eliminate an 
immediate hazard(s) to the trial participants.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
Signed: _____________________________________ Date: ______________ 
 
 


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Clinical Trial Protocol: QUILT-3.058 
 
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PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
ImmunityBio, Inc. 
Name of Investigational Products: 
1. N-803 (also known as ALT-803; recombinant human superagonist interleukin [IL]-15 
complex) 
2. PD-L1 t-haNK Suspension for Infusion (PD-L1 t-haNK for Infusion) 
Name of Approved Products: 
3. Cyclophosphamide (Cyclophosphamide Capsules, for oral use; or Cyclophosphamide Tablets, 
USP) 
4. Sacituzumab govitecan-hziy (TRODELVY™, for injection) 
Name of Active Ingredients 
Investigational Products: 
1. N-803, recombinant human superagonist IL-15 complex (also known as 
IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
2. PD-L1 t-haNK 
Approved Products: 
3. Cyclophosphamide (anhydrous) 
4. Sacituzumab govitecan-hziy  
Title of Study:  
Open-Label Phase 1b/2/3 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the 
Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Study Phase: 
Phase 1b/2/3 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 
 
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Study Objectives: 
Phase 1b 
Primary Objectives: 
• 
Determine the maximum tolerated dose (MTD) or highest tested dose (HTD) and designate 
a recommended phase 2 dose (RP2D).  
• 
Evaluate the overall safety profile of sacituzumab govitecan-hziy plus 
chemoimmunotherapy (cyclophosphamide, PD-L1 t-haNK, and N-803) in subjects with 
advanced triple-negative breast cancer (TNBC) after prior therapy. 
Secondary Objectives: 
• 
Obtain preliminary estimates of efficacy by objective response rate (ORR), duration of 
response (DOR), disease control rate (DCR), and progression free survival (PFS) per 
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified 
RECIST guidelines for immunotherapy trials (iRECIST), overall survival (OS), and 
quality of life (QoL) by patient-reported outcomes (PROs). 
Exploratory Objectives: 
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Phase 2 and Phase 3 
Primary Objectives: 
• 
Phase 2: Evaluate the efficacy of sacituzumab govitecan-hziy, cyclophosphamide, 
PD-L1 t-haNK, and N-803 as assessed by ORR per RECIST Version 1.1. 
• 
Phase 3: Compare the efficacy of sacituzumab govitecan-hziy vs sacituzumab govitecan-
hziy, cyclophosphamide, PD-L1 t-haNK, and N-803 as assessed by ORR per RECIST 
Version 1.1. 
Secondary Objectives: 
• 
Evaluate safety and obtain additional measures of efficacy by PFS, DOR, and DCR per 
RECIST Version 1.1 and iRECIST, ORR per iRECIST, OS, and QoL by PROs. 
Exploratory Objectives: 
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Study Design: 
This is a phase 1b/2/3 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-
hziy in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in 
subjects with TNBC after at least 2 prior treatments for metastatic disease. 
The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using 
a 3 + 3 design, and part 2 will involve the expansion of the RP2D to further evaluate the safety and 
efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study 
will be based on Simon’s two-stage optimal design.  
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemoimmunotherapy 
(cyclophosphamide, N-803, and PD-L1 t-haNK) as per the experimental treatment regimen outlined 
below. The dose of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 
 
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and will be set at the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD-L1 t haNK 
will remain the same in all dose level cohorts and phases.  
In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be 
assessed for dose-limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as 
follows: 
• 
Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) 
• 
Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) 
• 
Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV) 
In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 
4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 
1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into 
phase 2 should proceed. 
In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of 
Simon’s two-stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will 
proceed to the second stage. If the study proceeds to the second stage, an additional 41 subjects will be 
enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed 
response, the trial will proceed to phase 3.   
In the phase 3 portion of the study, subjects will be randomly assigned 1:1 to either the control arm or 
the experimental arm. Randomization will be stratified by baseline PD-L1 expression (tumor 
infiltrating immune cells 0% vs ≥ 1%) and by time from last line of therapy (< 6 months vs 
≥ 6 months). Subjects randomized to the experimental arm will receive sacituzumab govitecan-hziy in 
combination with cyclophosphamide, N-803, and PD-L1 t-haNK per the experimental treatment 
regimen outlined below. Subjects randomized to the control arm will receive sacituzumab govitecan-
hziy monotherapy per the control treatment regimen outlined below. 
All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles as 
follows: 
Experimental Treatment Regimen (All Phases): 
Days 1–5 and 15–19, every 3 weeks: 
• 
Cyclophosphamide (25 mg by mouth [PO] twice per day [BID]) 
Days 1 and 8, every 3 weeks: 
• 
PD-L1 t-haNK (~2 × 109 cells IV) 
• 
Sacituzumab govitecan-hziy (5.0, 7.5, or 10 mg/kg IV) 
per dose level cohort in phase 1b/at RP2D in phases 2 and 3 
Day 8, every 3 weeks:  
• 
N-803 (15 μg/kg subcutaneously [SC]) 
Control Treatment Regimen (Phase 3 Only): 
Days 1 and 8, every 3 weeks: 
• 
Sacituzumab govitecan-hziy (10 mg/kg intravenously [IV]) 
Treatment will be discontinued if the subject experiences disease progression or symptomatic 
deterioration indicating treatment failure, unacceptable toxicity, or a treatment delay > 3 weeks for any 
reason. (Treatment delays of up to 3 weeks will be allowed at the Investigator’s discretion.) The subject 


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may withdraw from the study at any time for any reason or may be withdrawn if the Investigator feels 
it is no longer in the subject’s best interest to continue treatment. 
Safety will be assessed for all subjects and will include vital signs, physical examinations, and the 
incidence and severity of adverse events (AEs), graded using the National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Blood samples will be 
collected for safety laboratory tests. 
Tumors will be assessed at screening, and tumor response will be assessed by the Investigator every 
8 weeks by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target 
lesions in accordance with RECIST Version 1.1 and iRECIST. Imaging should continue until 
progressive disease (PD) is confirmed or the subject completes study follow-up and the same mode of 
assessment (ie, CT/MRI) used to identify/evaluate lesions at baseline should be used throughout the 
course of the study unless subject safety necessitates a change (eg, allergic reaction to contrast media). 
Study Endpoints: 
Phase 1b 
Primary Endpoints: 
• 
MTD or HTD and RP2D. 
• 
Incidence of DLTs, treatment-emergent AEs, and serious AEs (SAEs), graded using the 
NCI CTCAE Version 5.0. 
Secondary Endpoints: 
• 
ORR per RECIST Version 1.1 and iRECIST. 
• 
PFS per RECIST Version 1.1 and iRECIST. 
• 
OS. 
• 
DOR per RECIST Version 1.1 and iRECIST. 
• 
DCR (confirmed CR, PR, or stable disease [SD] lasting for ≥ 8 weeks) per RECIST 
Version 1.1 and iRECIST. 
• 
QoL by PROs. 
• 
Laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
Tumor molecular profiles and correlations with subject outcomes. 
Phase 2 and Phase 3 
Primary Efficacy Endpoint: 
• 
ORR per RECIST Version 1.1 (based on investigator assessment for phase 2 and using 
blinded independent central review [BICR] for phase 3). 
Key Secondary Efficacy Endpoints: 
• 
PFS per RECIST Version 1.1 (based on investigator assessment for phase 2 and using 
BICR for phase 3). 


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Clinical Trial Protocol: QUILT-3.058 
 
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• 
OS. 
Additional Secondary Endpoints: 
• 
DOR per RECIST Version 1.1. 
• 
DCR, defined as percentage of subjects who have achieved confirmed complete response 
(CR), partial response (PR), or stable disease (SD) lasting for at least 2 months per 
RECIST Version 1.1. 
• 
ORR, PFS, DOR, and DCR evaluated by iRECIST. 
• 
QoL by PROs. 
Safety Endpoints: 
• 
Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 
5.0. 
• 
Safety laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
Tumor molecular profiles and correlations with subject outcomes.  
Enrollment (planned): 
In the phase 1b portion of the study, up to 16 subjects may be enrolled with up to 12 subjects in part 1 
(dose escalation) and up to 4 subjects in part 2 (dose expansion).  
In the phase 2 portion of the study, 22 subjects will be enrolled in the first stage of Simon’s two-stage 
optimal design. If the study proceeds to the second stage, an additional 41 subjects will be enrolled for 
a total of 63 subjects in the phase 2.  
In the phase 3 portion of the study, a total of 374 subjects will be randomized (1:1) to either the control 
or experimental arm initially. Based on the interim ORR analysis, the phase 3 sample size may be 
increased to a maximum of 748 subjects using “Promising Zone” methodology for an adaptive sample 
size increase. 
The maximum total enrollment for this study is 827 subjects. 
Inclusion and Exclusion Criteria: 
Inclusion Criteria: 
1. Age ≥ 18 years. 
2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 
3. Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments 
for TNBC. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and 
progesterone receptor (PgR) expression (both ≤ 1% of tumor cell nuclei), and human epidermal 
growth factor receptor 2 (HER2) overexpression and/or amplification (IHC 0 or 1+, or IHC 2+ 
and fluorescence in situ hybridization [FISH]-), according to American Society of Clinical 
Oncology/College of American Pathologists (ASCO/CAP) guideline criteria, as evaluated by 
local institutions. 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 
 
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4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. 
5. Have at least 1 measurable lesion of ≥ 1.0 cm and/or non-measurable disease evaluable in 
accordance with RECIST V1.1. 
6. Ability to attend required study visits and return for adequate follow-up, as required by this 
protocol. 
7. Agreement to practice effective contraception for female subjects of child-bearing potential 
and non-sterile males. Female subjects of child-bearing potential must agree to use effective 
contraception while on study and for at least 5 months after the last dose of study therapy. 
Non-sterile male subjects must agree to use a condom while on study and for up to 5 months 
after the last dose of study therapy. Effective contraception includes surgical sterilization (eg, 
vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with 
spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence. 
Exclusion Criteria: 
1. Serious uncontrolled concomitant disease that would contraindicate the use of the 
investigational drug used in this study or that would put the subject at high risk for treatment-
related complications. 
2. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's 
disease, autoimmune disease associated with lymphoma).  
3. Documented Gilbert’s syndrome. 
4. History of organ transplant requiring immunosuppression.  
5. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).  
6. Inadequate organ function, evidenced by the following laboratory results: 
a. Absolute neutrophil count (ANC) < 1000 cells/mm3. 
b. Platelet count < 75,000 cells/mm3. 
c. Hemoglobin < 9 g/dL. 
d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has 
documented Gilbert’s syndrome). 
e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) 
> 2.5 × ULN (> 5 × ULN in subjects with liver metastases). 
f. Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver 
metastases, or > 10 × ULN in subjects with bone metastases). 
g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. 
 
Each site should use its own institution’s ULN to determine eligibility. 
7. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically 
significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial 
infarction within 6 months prior to first study medication; unstable angina; congestive heart 
failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia 
requiring medication. 
8. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids 
(dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. 


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Clinical Trial Protocol: QUILT-3.058 
 
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Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who 
have known contrast allergies is allowed. 
9. Known hypersensitivity to any component of the study medication(s). 
10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug 
reaction with any of the study medications. 
11. Known uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) gene polymorphism 
resulting in reduced function. 
12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the 
protocol. 
13. Concurrent participation in any interventional clinical trial. 
14. Pregnant and nursing women. A negative serum pregnancy test during screening and a 
negative pregnancy test within 72 hours prior to the first dose must be documented before 
study therapy is administered to a female subject of child-bearing potential. 
Investigational Product, Dosage, and Mode of Administration:  
Experimental treatment regimen 
Investigational Products 
Dosage 
Mode of Administration 
N-803 
15 µg/kg on day 8 
SC 
PD-L1 t-haNK 
~2 × 109 cells/dose on days 1 and 8 
IV 
Approved Products 
Dosage 
Mode of Administration 
Cyclophosphamide  
25 mg BID on days 1–5 and 15–19 
PO 
Sacituzumab govitecan-hziy 
5.0, 7.5, or 10 mg/kg on days 1 and 8 
IV 
Duration of Treatment:  
The length of the treatment is 51 weeks or until unacceptable toxicity, disease progression, 
symptomatic deterioration indicating treatment failure, or treatment delay greater than 3 weeks for any 
reason. 
Duration of Follow-up: 
Subjects who discontinue study treatment should remain in the study and continue to be followed for: 
• 
CT or MRI imaging and response assessment 
• 
Collection of vital status every 12 weeks (± 2 weeks) 
Subjects should be followed until either death (any cause) or for a minimum of 48 months past 
administration of the first dose of study drug.  
After a subject has confirmed disease progression, he/she will continue to be followed for survival 
status via phone call until either death (any cause) or for a minimum of 48 months past administration 
of the first dose of study drug. 


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Reference Therapy, Dosage, and Mode of Administration:  
Control treatment regimen (phase 3 only) 
Approved Products 
Dosage 
Mode of Administration 
Sacituzumab govitecan-hziy 
10 mg/kg on days 1 and 8 
IV 
Evaluation of Endpoints: 
Safety 
Safety endpoints include assessments of DLTs, MTD or HTD, treatment-emergent AEs, SAEs, 
clinically significant changes in safety laboratory tests, and vital signs. All subjects will be evaluable 
for toxicity from the time of their first study treatment. Toxicities will be graded using the NCI 
CTCAE Version 5.0. or in the case of cytokine release syndrome (CRS) and CAR T-cell–related 
encephalopathy syndrome (CRES) using the specified grading system defined in the protocol. 
Efficacy 
Tumor response will be assessed by CT or MRI every 8 weeks and will be evaluated per RECIST 
Version 1.1 and iRECIST. In order to document PD, unscheduled tumor assessments may be done if 
the Investigator observes any signs and symptoms of PD. Efficacy endpoints include ORR, DOR, 
DCR, PFS, and OS. In phases 1b and 2, tumor response will be based on investigator assessment; in 
phase 3, tumor response will be based on BICR. 
Exploratory Analyses 
Tumor Molecular Profiling: Exploratory analyses will be conducted on tissue and blood to evaluate a 
potential biomarker signature to identify appropriate patients for the treatments tested in the trial. 
Statistical Methods: 
The phase 1b portion of the study will use a standard 3 + 3 design to determine the MTD or HTD and 
designate the RP2D. The phase 2 portion of the study will be based on Simon’s two-stage optimal 
design to evaluate the null hypothesis that the ORR is ≤ 33% tested against the one-sided alternative 
that the ORR is > 33%. 
Phase 3 Sample Size, Randomization, and Interim Analyses: The primary efficacy endpoint for the 
phase 3 portion of the study is ORR per RECIST Version 1.1 based on BICR. 
Initially 374 subjects will be randomly assigned (1:1) to either the control arm or the experimental arm 
(187 subjects per arm). The randomization will be stratified by baseline PD-L1 expression (tumor 
infiltrating immune cells 0% vs ≥ 1% and by time from last line of therapy (< 6 months vs ≥ 6 months). 
Sample size of 187 subjects per arm provides 90% power to detect an improvement in ORR from 33% 
to 50% based on a two-sided 5% type 1 error rate. 
An interim ORR analysis is planned when 50% of subjects (94 subjects per arm) are randomized and 
have been followed for at least 2 response assessments. The Lan DeMets/O’Brien Fleming spending 
function will be used for the interim and final ORR analyses which allocates α = 0.003 to the interim 
analysis and α = 0.049 to the final analysis. Positive efficacy may be claimed early if the interim ORR 
analysis shows superiority (ie, p-value < 0.003). Enrollment may be stopped early for futility if the 
interim ORR analysis displays a conditional power < 10%. Based on the interim ORR analysis, the 
phase 3 sample size may be increased to a maximum of 748 subjects using “Promising Zone” 
methodology for an adaptive sample size increase.  
All interim analyses will be performed by an independent statistician separate from the study team. The 
interim analyses results will not be shared with the study team during the conduct of the study. The 
interim analysis results will be presented to the Independent Data Monitoring Committee (IDMC) who 
may make recommendations to the Sponsor regarding safety and efficacy. 


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Analysis Populations 
In phases 1b and 2, all subjects receiving at least 1 dose of any study drug (ie, the safety population) 
will be included in the analysis of safety and efficacy. 
In phase 3, all randomized subjects (ie, intent-to-treat [ITT] population), regardless of whether subjects 
received any study drug or had any efficacy assessments collected, will be included in the efficacy 
analyses and analyzed according to the randomized treatment arm assigned. In phase 3, all subjects 
receiving at least 1 dose of study drug (ie, the safety population) will be included in the safety analyses 
and analyzed according to the actual treatment received. 
In phase 1b, endpoints will be summarized for each dose level and all phase 1b subjects; in phase 3 
endpoints will be summarized by each treatment arm. 
Safety Analyses 
The rate of DLTs and the MTD (or HTD) will be assessed in phase 1b. Overall safety will be assessed 
by descriptive analyses using tabulated frequencies of AEs by grade in terms of treatment-emergent 
AEs, SAEs, and clinically significant changes in safety laboratory tests and vital signs.  
Efficacy Analyses 
The ORR and DCR will be summarized along with the 95% confidence intervals (CIs) using Clopper-
Pearson methods. DOR, PFS, and OS will be analyzed using Kaplan-Meier methods.  
In phase 3, comparison of ORR and DCR between the control and experimental arms will be based on 
the Cochran-Mantel-Haenszel (CMH) test stratified by the randomization strata.  
The key secondary efficacy endpoints (PFS and OS) in phase 3 will be tested only if the primary 
efficacy endpoint, ORR, is statistically significant in favor of the experimental arm. In order to control 
the type 1 error rate for multiple key secondary efficacy endpoints, a hierarchical/gate-keeping 
approach will be used. Each key secondary efficacy endpoint will be tested at α = 0.05 according to the 
following hierarchy: 
• 
PFS 
• 
OS 
Comparison of PFS and OS between the control and experimental arms in phase 3 will be based on the 
stratified log-rank test stratified by the randomization strata. 
Exploratory Analyses 
Correlations of tumor molecular profiles with subject outcomes will be explored. 


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Clinical Trial Protocol: QUILT-3.058 
 
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Figure 1: 
Phase 1b Treatment Schema 
 
 


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Clinical Trial Protocol: QUILT-3.058 
 
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Figure 2: 
Phase 2 Treatment Schema 
 
 


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Clinical Trial Protocol: QUILT-3.058 
 
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Figure 3: 
Phase 3 Treatment Schema 
 
 


N-803 and PD-Ll t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 
APPENDIX 1. 
SPONSOR SIGNATURE 
Study Title: 
Open-Label Phase 1 b/2/3 Study of Sacituzumab Govitecan-Hziy 
Plus Chemoimmunotherapy for the Treatment of Subjects With 
Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Version Number 
1 
Date: 
15 March 2021 
This clinical study protocol was subject to critical review and has been approved by 
Immunity Bio. 
Signed: 
SandeepBobby Reddy, MD 
Chief Medical Officer 
ImmunitxBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: Bobby.Reddy@ImmunityBio.com 
Cell Phone: + 1-562-631-4945 
Confidential and Proprietary 
120 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
1 
TITLE PAGE 
OPEN-LABEL PHASE 1B/2 STUDY OF SACITUZUMAB 
GOVITECAN-HZIY PLUS CHEMOIMMUNOTHERAPY 
FOR THE TREATMENT OF SUBJECTS WITH 
ADVANCED TRIPLE-NEGATIVE BREAST CANCER 
AFTER PRIOR THERAPY 
 
Study Number: 
QUILT-3.058 
IND Sponsor: 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Sandeep Bobby Reddy, MD 
Chief Medical Officer,  
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: Bobby.Reddy@ImmunityBio.com 
Cell Phone: +1-562-631-4945 
 
Protocol Version 
Date 
Version 1 
15 March 2021 
Version 2 
27 April 2021 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
2 
STATEMENT OF COMPLIANCE 
This trial will be conducted in accordance with Good Clinical Practice (GCP) as described in the 
International Conference on Harmonization (ICH) Guideline for GCP E6(R2) and in accordance 
with United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) and the general ethical 
principles outlined in the Declaration of Helsinki. The study will receive approval from an 
Institutional Review Board (IRB) prior to commencement. The Principal Investigator will assure 
that no deviation from, or changes to the protocol will take place without prior agreement from 
the sponsor and documented approval from the IRB, except where necessary to eliminate an 
immediate hazard(s) to the trial participants.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
Signed: _____________________________________ Date: ______________ 
 
 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
3 
PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
ImmunityBio, Inc. 
Name of Investigational Products: 
1. N-803 (also known as ALT-803; recombinant human superagonist interleukin [IL]-15 
complex) 
2. PD-L1 t-haNK Suspension for Infusion (PD-L1 t-haNK for Infusion) 
Name of Approved Products: 
3. Cyclophosphamide (Cyclophosphamide Capsules, for oral use; or Cyclophosphamide Tablets, 
USP) 
4. Sacituzumab govitecan-hziy (TRODELVY™, for injection) 
Name of Active Ingredients 
Investigational Products: 
1. N-803, recombinant human superagonist IL-15 complex (also known as 
IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
2. PD-L1 t-haNK 
Approved Products: 
3. Cyclophosphamide (anhydrous) 
4. Sacituzumab govitecan-hziy  
Title of Study:  
Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the 
Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Investigational New Drug (IND) Number: 
027223 
Study Phase: 
Phase 1b/2 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
4 
Study Objectives: 
Phase 1b 
Primary Objectives: 
• 
Determine the maximum tolerated dose (MTD) or highest tested dose (HTD) and designate 
a recommended phase 2 dose (RP2D).  
• 
Evaluate the overall safety profile of sacituzumab govitecan-hziy plus 
chemoimmunotherapy (cyclophosphamide, PD-L1 t-haNK, and N-803) in subjects with 
advanced triple-negative breast cancer (TNBC) after prior therapy. 
Secondary Objectives: 
• 
Obtain preliminary estimates of efficacy by objective response rate (ORR), duration of 
response (DOR), disease control rate (DCR), and progression free survival (PFS) per 
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified 
RECIST guidelines for immunotherapy trials (iRECIST), overall survival (OS), and 
quality of life (QoL) by patient-reported outcomes (PROs). 
Exploratory Objectives: 
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Phase 2 
Primary Objectives: 
• 
Evaluate the efficacy of sacituzumab govitecan-hziy, cyclophosphamide, PD-L1 t-haNK, 
and N-803 as assessed by ORR per RECIST Version 1.1. 
Secondary Objectives: 
• 
Evaluate safety and obtain additional measures of efficacy by PFS, DOR, and DCR per 
RECIST Version 1.1 and iRECIST, ORR per iRECIST, OS, and QoL by PROs. 
Exploratory Objectives: 
• 
Characterize the pharmacokinetic (PK) profiles of N-803 and PD-L1 t-haNK. 
• 
Characterize the immunogenicity of N-803, PD-L1 t-haNK, and sacituzumab govitecan-
hziy and their correlations with subject outcomes and impact on PK.  
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Study Design: 
This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy 
in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects 
with TNBC after at least 2 prior treatments for metastatic disease. 
The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using 
a 3 + 3 design, and part 2 will involve the expansion of the RP2D to further evaluate the safety and 
efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study 
will be based on Simon’s two-stage optimal design.  
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemoimmunotherapy 
(cyclophosphamide, N-803, and PD-L1 t-haNK) as per the treatment regimen outlined below. The dose 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b and will be set at 
the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD-L1 t haNK will remain the 
same in all dose level cohorts and phases.  
In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be 
assessed for dose-limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as 
follows: 
• 
Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) 
• 
Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) 
• 
Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV) 
In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 
4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 
1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into 
phase 2 should proceed. 
In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of 
Simon’s two-stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will 
proceed to the second stage. If the study proceeds to the second stage, an additional 41 subjects will be 
enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed 
response, the combination therapy will be considered for further development. 
All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles as 
follows: 
Days 1 and 8, every 3 weeks: 
• 
Sacituzumab govitecan-hziy (5.0, 7.5, or 10 mg/kg IV) 
per dose level cohort in phase 1b/at RP2D in phase 2 
• 
PD-L1 t-haNK (~2 × 109 cells IV) 
Day 8, every 3 weeks:  
• 
N-803 (15 μg/kg subcutaneously [SC]) 
Days 1–5 and 15–19, every 3 weeks: 
• 
Cyclophosphamide (25 mg by mouth [PO] twice per day [BID]) 
Treatment will be discontinued if the subject experiences disease progression or symptomatic 
deterioration indicating treatment failure, unacceptable toxicity, or a treatment delay > 3 weeks for any 
reason. (Treatment delays of up to 3 weeks will be allowed at the Investigator’s discretion.) The subject 
may withdraw from the study at any time for any reason or may be withdrawn if the Investigator feels 
it is no longer in the subject’s best interest to continue treatment. 
Safety will be assessed for all subjects and will include vital signs, physical examinations, and the 
incidence and severity of adverse events (AEs), graded using the National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Blood samples will be 
collected for safety laboratory tests. 
Tumors will be assessed at screening, and tumor response will be assessed by the Investigator every 
8 weeks by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target 
lesions in accordance with RECIST Version 1.1 and iRECIST. Imaging should continue until 
progressive disease (PD) is confirmed or the subject completes study follow-up and the same mode of 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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assessment (ie, CT/MRI) used to identify/evaluate lesions at baseline should be used throughout the 
course of the study unless subject safety necessitates a change (eg, allergic reaction to contrast media). 
Study Endpoints: 
Phase 1b 
Primary Endpoints: 
• 
MTD or HTD and RP2D. 
• 
Incidence of DLTs, treatment-emergent AEs, and serious AEs (SAEs), graded using the 
NCI CTCAE Version 5.0. 
Secondary Endpoints: 
• 
ORR per RECIST Version 1.1 and iRECIST. 
• 
PFS per RECIST Version 1.1 and iRECIST. 
• 
OS. 
• 
DOR per RECIST Version 1.1 and iRECIST. 
• 
DCR (confirmed CR, PR, or stable disease [SD] lasting for ≥ 8 weeks) per RECIST 
Version 1.1 and iRECIST. 
• 
QoL by PROs. 
• 
Laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
Tumor molecular profiles and correlations with subject outcomes. 
Phase 2  
Primary Efficacy Endpoint: 
• 
ORR per RECIST Version 1.1. 
Key Secondary Efficacy Endpoints: 
• 
PFS per RECIST Version 1.1. 
• 
OS. 
Additional Secondary Endpoints: 
• 
DOR per RECIST Version 1.1. 
• 
DCR, defined as percentage of subjects who have achieved confirmed complete response 
(CR), partial response (PR), or stable disease (SD) lasting for at least 2 months per 
RECIST Version 1.1. 
• 
ORR, PFS, DOR, and DCR evaluated by iRECIST. 
• 
QoL by PROs. 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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Safety Endpoints: 
• 
Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 
5.0. 
• 
Safety laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
PK profiles of N-803 and PD-L1 t-haNK. 
• 
Immunogenicity of N-803 PD-L1 t-haNK, and sacituzumab govitecan-hziy; their 
correlations with subject outcomes and impact on PK. 
• 
Tumor molecular profiles and correlations with subject outcomes.  
Enrollment (planned): 
In the phase 1b portion of the study, up to 16 subjects may be enrolled with up to 12 subjects in part 1 
(dose escalation) and up to 4 subjects in part 2 (dose expansion).  
In the phase 2 portion of the study, 22 subjects will be enrolled in the first stage of Simon’s two-stage 
optimal design. If the study proceeds to the second stage, an additional 41 subjects will be enrolled for 
a total of 63 subjects in the phase 2.  
The maximum total enrollment for this study is 79 subjects. 
Inclusion and Exclusion Criteria: 
Inclusion Criteria: 
1. Age ≥ 18 years. 
2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 
3. Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments 
for TNBC. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and 
progesterone receptor (PgR) expression (both ≤ 1% of tumor cell nuclei), and human epidermal 
growth factor receptor 2 (HER2) overexpression and/or amplification (IHC 0 or 1+, or IHC 2+ 
and fluorescence in situ hybridization [FISH]-), according to American Society of Clinical 
Oncology/College of American Pathologists (ASCO/CAP) guideline criteria, as evaluated by 
local institutions. 
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. 
5. Have at least 1 measurable lesion of ≥ 1.0 cm and/or non-measurable disease evaluable in 
accordance with RECIST V1.1. 
6. Ability to attend required study visits and return for adequate follow-up, as required by this 
protocol. 
7. Agreement to practice effective contraception for female subjects of child-bearing potential 
and non-sterile males. Female subjects of child-bearing potential must agree to use effective 
contraception while on study and for at least 5 months after the last dose of study therapy. 
Non-sterile male subjects must agree to use a condom while on study and for up to 5 months 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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after the last dose of study therapy. Effective contraception includes surgical sterilization (eg, 
vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with 
spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence. 
Exclusion Criteria: 
1. Have previously received or are currently receiving treatment with sacituzumab 
govitecan-hziy. 
2. Serious uncontrolled concomitant disease that would contraindicate the use of the 
investigational drug used in this study or that would put the subject at high risk for treatment-
related complications. 
3. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's 
disease, autoimmune disease associated with lymphoma).  
4. Documented Gilbert’s syndrome. 
5. History of organ transplant requiring immunosuppression.  
6. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).  
7. Inadequate organ function, evidenced by the following laboratory results: 
a. Absolute neutrophil count (ANC) < 1500 cells/mm3. 
b. Platelet count < 75,000 cells/mm3. 
c. Hemoglobin < 9 g/dL. 
d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has 
documented Gilbert’s syndrome). 
e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) 
> 2.5 × ULN (> 5 × ULN in subjects with liver metastases). 
f. Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver 
metastases, or > 10 × ULN in subjects with bone metastases). 
g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. 
 
Each site should use its own institution’s ULN to determine eligibility. 
8. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically 
significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial 
infarction within 6 months prior to first study medication; unstable angina; congestive heart 
failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia 
requiring medication. 
9. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids 
(dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. 
Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who 
have known contrast allergies is allowed. 
10. Known hypersensitivity to any component of the study medication(s). 
11. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug 
reaction with any of the study medications. 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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12. Known uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) gene polymorphism 
resulting in reduced function. 
13. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the 
protocol. 
14. Concurrent participation in any interventional clinical trial. 
15. Pregnant and nursing women. A negative serum pregnancy test during screening and a 
negative pregnancy test within 72 hours prior to the first dose must be documented before 
study therapy is administered to a female subject of child-bearing potential. 
Investigational Product, Dosage, and Mode of Administration:  
Investigational Products 
Dosage 
Mode of Administration 
N-803 
15 µg/kg on day 8 
SC 
PD-L1 t-haNK 
~2 × 109 cells/dose on days 1 and 8 
IV 
Approved Products 
Dosage 
Mode of Administration 
Cyclophosphamide  
25 mg BID on days 1–5 and 15–19 
PO 
Sacituzumab govitecan-hziy 
5.0, 7.5, or 10 mg/kg on days 1 and 8 
IV 
Duration of Treatment:  
The length of the treatment is 51 weeks or until unacceptable toxicity, disease progression, 
symptomatic deterioration indicating treatment failure, or treatment delay greater than 3 weeks for any 
reason. 
Duration of Follow-up: 
Subjects who discontinue study treatment should remain in the study and continue to be followed for: 
• 
CT or MRI imaging and response assessment every 8 weeks (± 1 week) 
• 
Collection of vital status every 12 weeks (± 2 weeks) 
Subjects should be followed until either death (any cause) or for a minimum of 48 months past 
administration of the first dose of study drug.  
After a subject has confirmed disease progression, he/she will continue to be followed for survival 
status via phone call until either death (any cause) or for a minimum of 48 months past administration 
of the first dose of study drug. 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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Reference Therapy, Dosage, and Mode of Administration:  
Not applicable. 
Evaluation of Endpoints: 
Safety 
Safety endpoints include assessments of DLTs, MTD or HTD, treatment-emergent AEs, SAEs, 
clinically significant changes in safety laboratory tests, and vital signs. All subjects will be evaluable 
for toxicity from the time of their first study treatment. Toxicities will be graded using the NCI 
CTCAE Version 5.0. or in the case of cytokine release syndrome (CRS) and CAR T-cell–related 
encephalopathy syndrome (CRES) using the specified grading system defined in the protocol. 
Efficacy 
Tumor response will be assessed by CT or MRI every 8 weeks and will be evaluated per RECIST 
Version 1.1 and iRECIST. In order to document PD, unscheduled tumor assessments may be done if 
the Investigator observes any signs and symptoms of PD. Efficacy endpoints include ORR, DOR, 
DCR, PFS, and OS. Tumor response will be based on investigator assessment. 
Exploratory Analyses 
Pharmacokinetics(phase 2 only): The PK profile of N-803 will be evaluated using validated enzyme-
linked immunosorbent assay (ELISA) methods. The PK profile of PD-L1 t-haNK will be evaluated 
using quantitative polymerase chain reaction (qPCR). 
Immunogenicity (phase 2 only): Immunogenicity (antidrug antibodies [ADA], neutralizing antibodies 
[NAb], cross-reactivity) to N-803, PD-L1 t-haNK, and sacituzumab govitecan-hziy will be evaluated 
by standard immune assays. For PD-L1 t-haNK, cellular immunogenicity will also be characterized. 
Tumor Molecular Profiling: Exploratory analyses will be conducted on tissue and blood to evaluate a 
potential biomarker signature to identify appropriate patients for the treatments tested in the trial. 
Statistical Methods: 
The phase 1b portion of the study will use a standard 3 + 3 design to determine the MTD or HTD and 
designate the RP2D. The phase 2 portion of the study will be based on Simon’s two-stage optimal 
design to evaluate the null hypothesis that the ORR is ≤ 33% tested against the one-sided alternative 
that the ORR is > 33%. 
Analysis Populations 
All subjects receiving at least 1 dose of any study drug (ie, the safety population) will be included in 
the analysis of safety and efficacy. 
In phase 1b, endpoints will be summarized for each dose level and all phase 1b subjects. 
Safety Analyses 
The rate of DLTs and the MTD (or HTD) will be assessed in phase 1b. Overall safety will be assessed 
by descriptive analyses using tabulated frequencies of AEs by grade in terms of treatment-emergent 
AEs, SAEs, and clinically significant changes in safety laboratory tests and vital signs.  
Efficacy Analyses 
The ORR and DCR will be summarized along with the 95% confidence intervals (CIs) using Clopper-
Pearson methods. DOR, PFS, and OS will be analyzed using Kaplan-Meier methods.  
Exploratory Analyses 
Correlations of tumor molecular profiles with subject outcomes will be explored. Correlations of PK 
and immunogenicity with subject outcomes and the impact of immunogenicity on PK will be explored 
in phase 2. 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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Figure 1: 
Phase 1b Treatment Schema 
 
 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
 
Confidential and Proprietary 
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Figure 2: 
Phase 2 Treatment Schema 
 


N-803 and PD-Ll t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 1 
APPENDIX 1. SPONSOR SIGNATURE 
Study Title: 
Open-Label Phase 1 b/2 Study of Sacituzumab Govitecan-Hziy 
Plus Chemoimmunotherapy for the Treatment of Subjects With 
Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Version Number 
2 
Date: 
27 April 2021 
This clinical study protocol was subject to critical review and has been approved by 
lmmunityBio. 
Signed: 
Confidential and Proprietary 
114 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
1 
TITLE PAGE 
OPEN-LABEL PHASE 1B/2 STUDY OF SACITUZUMAB 
GOVITECAN-HZIY PLUS CHEMOIMMUNOTHERAPY 
FOR THE TREATMENT OF SUBJECTS WITH 
ADVANCED TRIPLE-NEGATIVE BREAST CANCER 
AFTER PRIOR THERAPY 
 
Study Number: 
QUILT-3.058 
IND Sponsor: 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Sandeep Bobby Reddy, MD 
Chief Medical Officer,  
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: Bobby.Reddy@ImmunityBio.com 
Cell Phone: +1-562-631-4945 
 
Protocol Version 
Date 
Version 1 
15 March 2021 
Version 2 
27 April 2021 
Version 3 
03 June 2021 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
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STATEMENT OF COMPLIANCE 
This trial will be conducted in accordance with Good Clinical Practice (GCP) as described in the 
International Conference on Harmonization (ICH) Guideline for GCP E6(R2) and in accordance 
with United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, and 21 CFR Part 312) and the general ethical 
principles outlined in the Declaration of Helsinki. The study will receive approval from an 
Institutional Review Board (IRB) prior to commencement. The Principal Investigator will assure 
that no deviation from, or changes to the protocol will take place without prior agreement from 
the sponsor and documented approval from the IRB, except where necessary to eliminate an 
immediate hazard(s) to the trial participants.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
Signed: _____________________________________ Date: ______________ 
 
 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
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PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
ImmunityBio, Inc. 
Name of Investigational Products: 
1. N-803 (also known as ALT-803; recombinant human superagonist interleukin [IL]-15 
complex) 
2. PD-L1 t-haNK Suspension for Infusion (PD-L1 t-haNK for Infusion) 
Name of Approved Products: 
3. Cyclophosphamide (Cyclophosphamide Capsules, for oral use; or Cyclophosphamide Tablets, 
USP) 
4. Sacituzumab govitecan-hziy (TRODELVY™, for injection) 
Name of Active Ingredients 
Investigational Products: 
1. N-803, recombinant human superagonist IL-15 complex (also known as 
IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
2. PD-L1 t-haNK 
Approved Products: 
3. Cyclophosphamide (anhydrous) 
4. Sacituzumab govitecan-hziy  
Title of Study:  
Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the 
Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Investigational New Drug (IND) Number: 
027223 
Study Phase: 
Phase 1b/2 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
4 
Study Objectives: 
Phase 1b 
Primary Objectives: 
• 
Determine the maximum tolerated dose (MTD) or highest tested dose (HTD) and designate 
a recommended phase 2 dose (RP2D).  
• 
Evaluate the overall safety profile of sacituzumab govitecan-hziy plus 
chemoimmunotherapy (cyclophosphamide, PD-L1 t-haNK, and N-803) in subjects with 
advanced triple-negative breast cancer (TNBC) after prior therapy. 
Secondary Objectives: 
• 
Obtain preliminary estimates of efficacy by objective response rate (ORR), duration of 
response (DOR), disease control rate (DCR), and progression free survival (PFS) per 
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified 
RECIST guidelines for immunotherapy trials (iRECIST), overall survival (OS), and 
quality of life (QoL) by patient-reported outcomes (PROs). 
Exploratory Objectives: 
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Phase 2 
Primary Objectives: 
• 
Evaluate the efficacy of sacituzumab govitecan-hziy, cyclophosphamide, PD-L1 t-haNK, 
and N-803 as assessed by ORR per RECIST Version 1.1. 
Secondary Objectives: 
• 
Evaluate safety and obtain additional measures of efficacy by PFS, DOR, and DCR per 
RECIST Version 1.1 and iRECIST, ORR per iRECIST, OS, and QoL by PROs. 
Exploratory Objectives: 
• 
Characterize the pharmacokinetic (PK) profiles of N-803 and PD-L1 t-haNK. 
• 
Characterize the immunogenicity of N-803, PD-L1 t-haNK, and sacituzumab govitecan-
hziy and their correlations with subject outcomes and impact on PK.  
• 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Study Design: 
This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy 
in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects 
with TNBC after at least 2 prior treatments for metastatic disease. 
The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using 
a 3 + 3 design, and part 2 will involve the expansion of the RP2D to further evaluate the safety and 
efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study 
will be based on Simon’s two-stage optimal design.  
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemoimmunotherapy 
(cyclophosphamide, N-803, and PD-L1 t-haNK) as per the treatment regimen outlined below. The dose 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
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of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b and will be set at 
the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD-L1 t haNK will remain the 
same in all dose level cohorts and phases.  
In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be 
assessed for dose-limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as 
follows: 
• 
Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) 
• 
Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) 
• 
Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV) 
In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 
4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 
1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into 
phase 2 should proceed. 
In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of 
Simon’s two-stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will 
proceed to the second stage. If the study proceeds to the second stage, an additional 41 subjects will be 
enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed 
response, the combination therapy will be considered for further development. 
All subjects may receive up to 17 cycles (ie, 51 weeks) of treatment administered in 3-week cycles as 
follows: 
Days 1 and 8, every 3 weeks: 
• 
Sacituzumab govitecan-hziy (5.0, 7.5, or 10 mg/kg IV) 
per dose level cohort in phase 1b/at RP2D in phase 2 
• 
PD-L1 t-haNK (~2 × 109 cells IV) 
Day 8, every 3 weeks:  
• 
N-803 (15 μg/kg subcutaneously [SC]) 
Days 1–5 and 15–19, every 3 weeks: 
• 
Cyclophosphamide (25 mg by mouth [PO] twice per day [BID]) 
Treatment will be discontinued if the subject experiences disease progression or symptomatic 
deterioration indicating treatment failure, unacceptable toxicity, or a treatment delay > 3 weeks for any 
reason. (Treatment delays of up to 3 weeks will be allowed at the Investigator’s discretion.) The subject 
may withdraw from the study at any time for any reason or may be withdrawn if the Investigator feels 
it is no longer in the subject’s best interest to continue treatment. 
Safety will be assessed for all subjects and will include vital signs, physical examinations, and the 
incidence and severity of adverse events (AEs), graded using the National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Blood samples will be 
collected for safety laboratory tests. 
Tumors will be assessed at screening, and tumor response will be assessed by the Investigator every 
8 weeks by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target 
lesions in accordance with RECIST Version 1.1 and iRECIST. Imaging should continue until 
progressive disease (PD) is confirmed or the subject completes study follow-up and the same mode of 


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assessment (ie, CT/MRI) used to identify/evaluate lesions at baseline should be used throughout the 
course of the study unless subject safety necessitates a change (eg, allergic reaction to contrast media). 
Study Endpoints: 
Phase 1b 
Primary Endpoints: 
• 
MTD or HTD and RP2D. 
• 
Incidence of DLTs, treatment-emergent AEs, and serious AEs (SAEs), graded using the 
NCI CTCAE Version 5.0. 
Secondary Endpoints: 
• 
ORR per RECIST Version 1.1 and iRECIST. 
• 
PFS per RECIST Version 1.1 and iRECIST. 
• 
OS. 
• 
DOR per RECIST Version 1.1 and iRECIST. 
• 
DCR (confirmed CR, PR, or stable disease [SD] lasting for ≥ 8 weeks) per RECIST 
Version 1.1 and iRECIST. 
• 
QoL by PROs. 
• 
Laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
Tumor molecular profiles and correlations with subject outcomes. 
Phase 2  
Primary Efficacy Endpoint: 
• 
ORR per RECIST Version 1.1. 
Key Secondary Efficacy Endpoints: 
• 
PFS per RECIST Version 1.1. 
• 
OS. 
Additional Secondary Endpoints: 
• 
DOR per RECIST Version 1.1. 
• 
DCR, defined as percentage of subjects who have achieved confirmed complete response 
(CR), partial response (PR), or stable disease (SD) lasting for at least 2 months per 
RECIST Version 1.1. 
• 
ORR, PFS, DOR, and DCR evaluated by iRECIST. 
• 
QoL by PROs. 


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Safety Endpoints: 
• 
Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 
5.0. 
• 
Safety laboratory tests. 
• 
Vital signs. 
Exploratory Endpoints: 
• 
PK profiles of N-803 and PD-L1 t-haNK. 
• 
Immunogenicity of N-803 PD-L1 t-haNK, and sacituzumab govitecan-hziy; their 
correlations with subject outcomes and impact on PK. 
• 
Tumor molecular profiles and correlations with subject outcomes.  
Enrollment (planned): 
In the phase 1b portion of the study, up to 16 subjects may be enrolled with up to 12 subjects in part 1 
(dose escalation) and up to 4 subjects in part 2 (dose expansion).  
In the phase 2 portion of the study, 22 subjects will be enrolled in the first stage of Simon’s two-stage 
optimal design. If the study proceeds to the second stage, an additional 41 subjects will be enrolled for 
a total of 63 subjects in the phase 2.  
The maximum total enrollment for this study is 79 subjects. 
Inclusion and Exclusion Criteria: 
Inclusion Criteria: 
1. Age ≥ 18 years. 
2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 
3. Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments 
for TNBC. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and 
progesterone receptor (PgR) expression (both ≤ 1% of tumor cell nuclei), and human epidermal 
growth factor receptor 2 (HER2) overexpression and/or amplification (IHC 0 or 1+, or IHC 2+ 
and fluorescence in situ hybridization [FISH]-), according to American Society of Clinical 
Oncology/College of American Pathologists (ASCO/CAP) guideline criteria, as evaluated by 
local institutions. 
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. 
5. Have at least 1 measurable lesion of ≥ 1.0 cm and/or non-measurable disease evaluable in 
accordance with RECIST V1.1. 
6. Ability to attend required study visits and return for adequate follow-up, as required by this 
protocol. 
7. Agreement to practice effective contraception for female subjects of child-bearing potential 
and non-sterile males. Female subjects of child-bearing potential must agree to use effective 
contraception while on study and for at least 5 months after the last dose of study therapy. 
Non-sterile male subjects must agree to use a condom while on study and for up to 5 months 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
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after the last dose of study therapy. Effective contraception includes surgical sterilization (eg, 
vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with 
spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence. 
Exclusion Criteria: 
1. Have previously received or are currently receiving treatment with sacituzumab 
govitecan-hziy. 
2. Serious uncontrolled concomitant disease that would contraindicate the use of the 
investigational drug used in this study or that would put the subject at high risk for treatment-
related complications. 
3. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's 
disease, autoimmune disease associated with lymphoma).  
4. History of organ transplant requiring immunosuppression.  
5. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).  
6. Inadequate organ function, evidenced by the following laboratory results: 
a. Absolute neutrophil count (ANC) < 1500 cells/mm3. 
b. Platelet count < 75,000 cells/mm3. 
c. Hemoglobin < 9 g/dL. 
d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has 
documented Gilbert’s syndrome). 
e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) 
> 2.5 × ULN (> 5 × ULN in subjects with liver metastases). 
f. Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver 
metastases, or > 10 × ULN in subjects with bone metastases). 
g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. 
 
Each site should use its own institution’s ULN to determine eligibility. 
7. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically 
significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial 
infarction within 6 months prior to first study medication; unstable angina; congestive heart 
failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia 
requiring medication. 
8. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids 
(dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. 
Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who 
have known contrast allergies is allowed. 
9. Known hypersensitivity to any component of the study medication(s). 
10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug 
reaction with any of the study medications. 
11. Known uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) gene polymorphism 
resulting in reduced function. 


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Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
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12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the 
protocol. 
13. Concurrent participation in any interventional clinical trial. 
14. Pregnant and nursing women. A negative serum pregnancy test during screening and a 
negative pregnancy test within 72 hours prior to the first dose must be documented before 
study therapy is administered to a female subject of child-bearing potential. 
Investigational Product, Dosage, and Mode of Administration:  
Investigational Products 
Dosage 
Mode of Administration 
N-803 
15 µg/kg on day 8 
SC 
PD-L1 t-haNK 
~2 × 109 cells/dose on days 1 and 8 
IV 
Approved Products 
Dosage 
Mode of Administration 
Cyclophosphamide  
25 mg BID on days 1–5 and 15–19 
PO 
Sacituzumab govitecan-hziy 
5.0, 7.5, or 10 mg/kg on days 1 and 8 
IV 
Duration of Treatment:  
The length of the treatment is 51 weeks or until unacceptable toxicity, disease progression, 
symptomatic deterioration indicating treatment failure, or treatment delay greater than 3 weeks for any 
reason. 
Duration of Follow-up: 
Subjects who discontinue study treatment should remain in the study and continue to be followed for: 
• 
CT or MRI imaging and response assessment every 8 weeks (± 1 week) 
• 
Collection of vital status every 12 weeks (± 2 weeks) 
Subjects should be followed until either death (any cause) or for a minimum of 48 months past 
administration of the first dose of study drug.  
After a subject has confirmed disease progression, he/she will continue to be followed for survival 
status via phone call until either death (any cause) or for a minimum of 48 months past administration 
of the first dose of study drug. 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
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Reference Therapy, Dosage, and Mode of Administration:  
Not applicable. 
Evaluation of Endpoints: 
Safety 
Safety endpoints include assessments of DLTs, MTD or HTD, treatment-emergent AEs, SAEs, 
clinically significant changes in safety laboratory tests, and vital signs. All subjects will be evaluable 
for toxicity from the time of their first study treatment. Toxicities will be graded using the NCI 
CTCAE Version 5.0. or in the case of cytokine release syndrome (CRS) and CAR T-cell–related 
encephalopathy syndrome (CRES) using the specified grading system defined in the protocol. 
Efficacy 
Tumor response will be assessed by CT or MRI every 8 weeks and will be evaluated per RECIST 
Version 1.1 and iRECIST. In order to document PD, unscheduled tumor assessments may be done if 
the Investigator observes any signs and symptoms of PD. Efficacy endpoints include ORR, DOR, 
DCR, PFS, and OS. Tumor response will be based on investigator assessment. 
Exploratory Analyses 
Pharmacokinetics(phase 2 only): The PK profile of N-803 will be evaluated using validated enzyme-
linked immunosorbent assay (ELISA) methods. The PK profile of PD-L1 t-haNK will be evaluated 
using quantitative polymerase chain reaction (qPCR). 
Immunogenicity (phase 2 only): Immunogenicity (antidrug antibodies [ADA], neutralizing antibodies 
[NAb], cross-reactivity) to N-803, PD-L1 t-haNK, and sacituzumab govitecan-hziy will be evaluated 
by standard immune assays. For PD-L1 t-haNK, cellular immunogenicity will also be characterized. 
Tumor Molecular Profiling: Exploratory analyses will be conducted on tissue and blood to evaluate a 
potential biomarker signature to identify appropriate patients for the treatments tested in the trial. 
Statistical Methods: 
The phase 1b portion of the study will use a standard 3 + 3 design to determine the MTD or HTD and 
designate the RP2D. The phase 2 portion of the study will be based on Simon’s two-stage optimal 
design to evaluate the null hypothesis that the ORR is ≤ 33% tested against the one-sided alternative 
that the ORR is > 33%. 
Analysis Populations 
All subjects receiving at least 1 dose of any study drug (ie, the safety population) will be included in 
the analysis of safety and efficacy. 
In phase 1b, endpoints will be summarized for each dose level and all phase 1b subjects. 
Safety Analyses 
The rate of DLTs and the MTD (or HTD) will be assessed in phase 1b. Overall safety will be assessed 
by descriptive analyses using tabulated frequencies of AEs by grade in terms of treatment-emergent 
AEs, SAEs, and clinically significant changes in safety laboratory tests and vital signs.  
Efficacy Analyses 
The ORR and DCR will be summarized along with the 95% confidence intervals (CIs) using Clopper-
Pearson methods. DOR, PFS, and OS will be analyzed using Kaplan-Meier methods.  
Exploratory Analyses 
Correlations of tumor molecular profiles with subject outcomes will be explored. Correlations of PK 
and immunogenicity with subject outcomes and the impact of immunogenicity on PK will be explored 
in phase 2. 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
Confidential and Proprietary 
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Figure 1: 
Phase 1b Treatment Schema 
 
 


N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
 
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Figure 2: 
Phase 2 Treatment Schema 
 
 


N-803 and PD-L 1 t-haNK 
lmmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Amendment 2 
APPENDIX 1. SPONSOR SIGNATURE 
Study Title: 
Open-Label Phase 1 b/2 Study of Sacituzurnab Govitecan-Hziy 
Plus Chemoimmunotherapy for the Treatment of Subjects With 
Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Version Number 
3 
Date: 
03 June 2021 
This clinical study protocol was subject to critical review and has been approved by 
lmmunityBio. 
Signed: 
San eep obby Reddy, MD 
Chief Medical Officer 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Emai I: Bobby.Reddy@ImmunityBio.com 
Cell Phone: + 1-562-631-4945 
Confidential and Proprietary 
I 14 
Date: Jl!14rt clJNG l( ( UJ 2 / 


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
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TITLE PAGE 
OPEN-LABEL PHASE 1B/2 STUDY OF SACITUZUMAB 
GOVITECAN-HZIY PLUS CHEMOIMMUNOTHERAPY 
FOR THE TREATMENT OF SUBJECTS WITH 
ADVANCED TRIPLE-NEGATIVE BREAST CANCER 
AFTER PRIOR THERAPY 
 
Study Number: 
QUILT-3.058 
IND Sponsor: 
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Sponsor Contact:  
(For medical questions/emergencies) 
Sandeep Bobby Reddy, MD 
Chief Medical Officer,  
ImmunityBio, Inc. 
9920 Jefferson Blvd 
Culver City, CA 90232 
Email: Bobby.Reddy@ImmunityBio.com 
Cell Phone: +1-562-631-4945 
 
Protocol Version 
Date 
Version 1 
15 March 2021 
Version 2 
27 April 2021 
Version 3 
03 June 2021 
Version 4 
06 September 2022 
1


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
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STATEMENT OF COMPLIANCE 
This trial will be conducted in accordance with Good Clinical Practice (GCP) as described in the 
International Conference on Harmonization (ICH) Guideline for GCP E6(R2) and in accordance 
with United States (US) Code of Federal Regulations (CFR) applicable to clinical studies and the 
general ethical principles outlined in the Declaration of Helsinki. The study will receive approval 
from an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) prior to 
commencement. The Principal Investigator will assure that no deviation from, or changes to the 
protocol will take place without prior agreement from the sponsor and documented approval 
from the IRB, except where necessary to eliminate an immediate hazard(s) to the trial 
participants.  
I agree to ensure that all staff members involved in the conduct of this study are informed about 
their obligations in meeting the above commitments.  
 
 
Signed: _____________________________________ Date: ______________ 
 
 
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N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
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PROTOCOL SYNOPSIS 
Name of Sponsor/Company: 
ImmunityBio, Inc. 
Name of Investigational Products: 
1. N-803 (also known as ALT-803; recombinant human superagonist interleukin [IL]-15 
complex) 
2. PD-L1 t-haNK Suspension for Infusion (PD-L1 t-haNK for Infusion) 
Name of Approved Products: 
3. Cyclophosphamide (Cyclophosphamide Capsules, for oral use; or Cyclophosphamide Tablets, 
USP) 
4. Sacituzumab govitecan-hziy (TRODELVY™, for injection) 
Name of Active Ingredients 
Investigational Products: 
1. N-803, recombinant human superagonist IL-15 complex (also known as 
IL-15N72D:IL-15RαSu/IgG1 Fc complex) 
2. PD-L1 t-haNK 
Approved Products: 
3. Cyclophosphamide (anhydrous) 
4. Sacituzumab govitecan-hziy  
Title of Study:  
Open-Label Phase 1b/2 Study of Sacituzumab Govitecan-Hziy Plus Chemoimmunotherapy for the 
Treatment of Subjects With Advanced Triple-Negative Breast Cancer After Prior Therapy. 
Study Number: 
QUILT-3.058 
Investigational New Drug (IND) Number: 
027223 
Study Phase: 
Phase 1b/2 
3


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
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Study Objectives: 
Phase 1b 
Primary Objectives: 
 
Determine the maximum tolerated dose (MTD) or highest tested dose (HTD) and designate 
a recommended phase 2 dose (RP2D).  
 
Evaluate the overall safety profile of sacituzumab govitecan-hziy plus 
chemoimmunotherapy (cyclophosphamide, PD-L1 t-haNK, and N-803) in subjects with 
advanced triple-negative breast cancer (TNBC) after prior therapy. 
Secondary Objectives: 
 
Obtain preliminary estimates of efficacy by objective response rate (ORR), duration of 
response (DOR), disease control rate (DCR), and progression free survival (PFS) per 
Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and modified 
RECIST guidelines for immunotherapy trials (iRECIST), overall survival (OS), and 
quality of life (QoL) by patient-reported outcomes (PROs). 
Exploratory Objectives: 
 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Phase 2 
Primary Objectives: 
 
Evaluate the efficacy of sacituzumab govitecan-hziy, cyclophosphamide, PD-L1 t-haNK, 
and N-803 as assessed by ORR per RECIST Version 1.1. 
Secondary Objectives: 
 
Evaluate safety and obtain additional measures of efficacy by PFS, DOR, and DCR per 
RECIST Version 1.1 and iRECIST, ORR per iRECIST, OS, and QoL by PROs. 
Exploratory Objectives: 
 
Characterize the pharmacokinetic (PK) profiles of N-803 and PD-L1 t-haNK. 
 
Characterize the immunogenicity of N-803, PD-L1 t-haNK, and sacituzumab govitecan-
hziy and their correlations with subject outcomes and impact on PK.  
 
Assess tumor molecular profiles and their correlations with subject outcomes. 
Study Design: 
This is a phase 1b/2 open-label study to evaluate the safety and efficacy of sacituzumab govitecan-hziy 
in combination with chemoimmunotherapy (cyclophosphamide, N-803, and PD-L1 t-haNK) in subjects 
with TNBC after at least 2 prior treatments for metastatic disease. 
The phase 1b portion of the study will be conducted in 2 parts: part 1 will involve dose escalation using 
a 3 + 3 design, and part 2 will involve the expansion of the RP2D to further evaluate the safety and 
efficacy of sacituzumab govitecan-hziy plus chemoimmunotherapy. The phase 2 portion of the study 
will be based on Simon’s two-stage optimal design.  
In phases 1b and 2, all subjects will receive sacituzumab govitecan-hziy plus chemoimmunotherapy 
(cyclophosphamide, N-803, and PD-L1 t-haNK) as per the treatment regimen outlined below. The dose 
4


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
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of sacituzumab govitecan-hziy will be dependent on dose level cohort for phase 1b and will be set at 
the RP2D for phase 2. The doses of cyclophosphamide, N-803, and PD-L1 t haNK will remain the 
same in all dose level cohorts and phases.  
In part 1 of phase 1b, 3 to 6 subjects will be sequentially enrolled starting at dose level 1 and will be 
assessed for dose-limiting toxicities (DLTs). Dose level cohorts for sacituzumab govitecan-hziy are as 
follows: 
 
Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) 
 
Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) 
 
Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV) 
In part 2 of phase 1b, dose expansion will occur when the RP2D has been determined. An additional 
4 subjects may be enrolled, for a total of up to 10 subjects at the RP2D. Following part 2 of the phase 
1b portion of the study, the Safety Review Committee (SRC) will meet to determine if enrollment into 
phase 2 should proceed. 
In the phase 2 portion of the study, 22 subjects will be enrolled at the RP2D in the first stage of 
Simon’s two-stage optimal design. If ≥ 9 of 22 subjects exhibit a confirmed response, the study will 
proceed to the second stage. If the study proceeds to the second stage, an additional 41 subjects will be 
enrolled for a total of 63 subjects in the phase 2. If ≥ 27 of the 63 subjects exhibit a confirmed 
response, the combination therapy will be considered for further development. 
All subjects may receive up to 41 cycles (ie, 123 weeks) of treatment administered in 3-week cycles as 
follows: 
Days 1 and 8, every 3 weeks: 
 
Sacituzumab govitecan-hziy (5.0, 7.5, or 10 mg/kg IV) 
per dose level cohort in phase 1b/at RP2D in phase 2 
 
PD-L1 t-haNK (~2 × 109 cells IV) 
Day 8, every 3 weeks:  
 
N-803 (15 μg/kg subcutaneously [SC]) 
Days 1–5 and 15–19, every 3 weeks: 
 
Cyclophosphamide (25 mg by mouth [PO] twice per day [BID]) 
Treatment will be discontinued if the subject experiences disease progression or symptomatic 
deterioration indicating treatment failure, unacceptable toxicity, or a treatment delay > 3 weeks for any 
reason. (Treatment delays of up to 3 weeks will be allowed at the Investigator’s discretion.) The subject 
may withdraw from the study at any time for any reason or may be withdrawn if the Investigator feels 
it is no longer in the subject’s best interest to continue treatment. 
Safety will be assessed for all subjects and will include vital signs, physical examinations, and the 
incidence and severity of adverse events (AEs), graded using the National Cancer Institute (NCI) 
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. Blood samples will be 
collected for safety laboratory tests. 
Tumors will be assessed at screening, and tumor response will be assessed by the Investigator every 
8 weeks by computed tomography (CT) or magnetic resonance imaging (MRI) of target and non-target 
lesions in accordance with RECIST Version 1.1 and iRECIST. Imaging should continue until 
progressive disease (PD) is confirmed or the subject completes study follow-up and the same mode of 
5


N-803 and PD-L1 t-haNK 
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Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
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assessment (ie, CT/MRI) used to identify/evaluate lesions at baseline should be used throughout the 
course of the study unless subject safety necessitates a change (eg, allergic reaction to contrast media). 
Study Endpoints: 
Phase 1b 
Primary Endpoints: 
 
MTD or HTD and RP2D. 
 
Incidence of DLTs, treatment-emergent AEs, and serious AEs (SAEs), graded using the 
NCI CTCAE Version 5.0. 
Secondary Endpoints: 
 
ORR per RECIST Version 1.1 and iRECIST. 
 
PFS per RECIST Version 1.1 and iRECIST. 
 
OS. 
 
DOR per RECIST Version 1.1 and iRECIST. 
 
DCR (confirmed CR, PR, or stable disease [SD] lasting for ≥ 8 weeks) per RECIST 
Version 1.1 and iRECIST. 
 
QoL by PROs. 
 
Laboratory tests. 
 
Vital signs. 
Exploratory Endpoints: 
 
Tumor molecular profiles and correlations with subject outcomes. 
Phase 2  
Primary Efficacy Endpoint: 
 
ORR per RECIST Version 1.1. 
Key Secondary Efficacy Endpoints: 
 
PFS per RECIST Version 1.1. 
 
OS. 
Additional Secondary Endpoints: 
 
DOR per RECIST Version 1.1. 
 
DCR, defined as percentage of subjects who have achieved confirmed complete response 
(CR), partial response (PR), or stable disease (SD) lasting for at least 2 months per 
RECIST Version 1.1. 
 
ORR, PFS, DOR, and DCR evaluated by iRECIST. 
 
QoL by PROs. 
6


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Safety Endpoints: 
 
Incidence of treatment-emergent AEs and SAEs, graded using the NCI CTCAE Version 
5.0. 
 
Safety laboratory tests. 
 
Vital signs. 
Exploratory Endpoints: 
 
PK profiles of N-803 and PD-L1 t-haNK. 
 
Immunogenicity of N-803 PD-L1 t-haNK, and sacituzumab govitecan-hziy; their 
correlations with subject outcomes and impact on PK. 
 
Tumor molecular profiles and correlations with subject outcomes.  
Enrollment (planned): 
In the phase 1b portion of the study, up to 16 subjects may be enrolled with up to 12 subjects in part 1 
(dose escalation) and up to 4 subjects in part 2 (dose expansion).  
In the phase 2 portion of the study, 22 subjects will be enrolled in the first stage of Simon’s two-stage 
optimal design. If the study proceeds to the second stage, an additional 41 subjects will be enrolled for 
a total of 63 subjects in the phase 2.  
The maximum total enrollment for this study is 79 subjects. 
Inclusion and Exclusion Criteria: 
Inclusion Criteria: 
1. Age ≥ 18 years. 
2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional 
Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 
3. Histologically confirmed stage IV TNBC. Subjects must have had at least 2 prior treatments 
for TNBC. TNBC is defined as breast cancer that lacks estrogen receptor (ER) and 
progesterone receptor (PgR) expression (both ≤ 1% of tumor cell nuclei), and human epidermal 
growth factor receptor 2 (HER2) overexpression and/or amplification (IHC 0 or 1+, or IHC 2+ 
and fluorescence in situ hybridization [FISH]-), according to American Society of Clinical 
Oncology/College of American Pathologists (ASCO/CAP) guideline criteria, as evaluated by 
local institutions. 
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2. 
5. Have at least 1 measurable lesion of ≥ 1.0 cm and/or non-measurable disease evaluable in 
accordance with RECIST V1.1. 
6. Ability to attend required study visits and return for adequate follow-up, as required by this 
protocol. 
7. Agreement to practice effective contraception for female subjects of child-bearing potential 
and non-sterile males. Female subjects of child-bearing potential must agree to use effective 
contraception while on study and for at least 5 months after the last dose of study therapy. 
Non-sterile male subjects must agree to use a condom while on study and for up to 5 months 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Version 4 
 
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after the last dose of study therapy. Effective contraception includes surgical sterilization (eg, 
vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with 
spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence. 
Exclusion Criteria: 
1. Have previously received or are currently receiving treatment with sacituzumab 
govitecan-hziy. 
2. Serious uncontrolled concomitant disease that would contraindicate the use of the 
investigational drug used in this study or that would put the subject at high risk for treatment-
related complications. 
3. Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's 
disease, autoimmune disease associated with lymphoma).  
4. History of organ transplant requiring immunosuppression.  
5. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).  
6. Inadequate organ function, evidenced by the following laboratory results: 
a. Absolute neutrophil count (ANC) < 1500 cells/mm3. 
b. Platelet count < 75,000 cells/mm3. 
c. Hemoglobin < 9 g/dL. 
d. Total bilirubin greater than the upper limit of normal (ULN; unless the subject has 
documented Gilbert’s syndrome). 
e. Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) 
> 2.5 × ULN (> 5 × ULN in subjects with liver metastases). 
f. Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver 
metastases, or > 10 × ULN in subjects with bone metastases). 
g. Serum creatinine > 2.0 mg/dL or 177 μmol/L. 
 
Each site should use its own institution’s ULN to determine eligibility. 
7. Uncontrolled hypertension (systolic > 160 mm Hg and/or diastolic > 110 mm Hg) or clinically 
significant (ie, active) cardiovascular disease, cerebrovascular accident/stroke, or myocardial 
infarction within 6 months prior to first study medication; unstable angina; congestive heart 
failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia 
requiring medication. 
8. Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids 
(dose equivalent to or greater than 10 mg/day methylprednisolone), excluding inhaled steroids. 
Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in subjects who 
have known contrast allergies is allowed. 
9. Known hypersensitivity to any component of the study medication(s). 
10. Subjects taking any medication(s) (herbal or prescribed) known to have an adverse drug 
reaction with any of the study medications. 
11. Known uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1) gene polymorphism 
resulting in reduced function. 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
9 
12. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the 
protocol. 
13. Concurrent participation in any interventional clinical trial. 
14. Pregnant and nursing women. A negative serum pregnancy test during screening and a 
negative pregnancy test within 72 hours prior to the first dose must be documented before 
study therapy is administered to a female subject of child-bearing potential. 
Investigational Product, Dosage, and Mode of Administration:  
Investigational Products 
Dosage 
Mode of Administration
N-803 
15 µg/kg on day 8 
SC 
PD-L1 t-haNK 
~2 × 109 cells/dose on days 1 and 8 
IV 
Approved Products 
Dosage 
Mode of Administration
Cyclophosphamide  
25 mg BID on days 1–5 and 15–19 
PO 
Sacituzumab govitecan-hziy 
5.0, 7.5, or 10 mg/kg on days 1 and 8 
IV 
 
Duration of Treatment:  
The length of the treatment is 123 weeks or until unacceptable toxicity, disease progression, 
symptomatic deterioration indicating treatment failure, or treatment delay greater than 3 weeks for any 
reason. 
Duration of Follow-up: 
Subjects who discontinue study treatment should remain in the study and continue to be followed for: 
 
CT or MRI imaging and response assessment every 8 weeks (± 1 week) 
 
Collection of vital status every 12 weeks (± 2 weeks) 
Subjects should be followed until either death (any cause) or for a minimum of 12 months past 
administration of the last dose of study drug.  
After a subject has confirmed disease progression, he/she will continue to be followed for survival 
status via phone call until either death (any cause) or for a minimum of 12 months past administration 
of the last dose of study drug. 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
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Reference Therapy, Dosage, and Mode of Administration:  
Not applicable. 
Evaluation of Endpoints: 
Safety 
Safety endpoints include assessments of DLTs, MTD or HTD, treatment-emergent AEs, SAEs, 
clinically significant changes in safety laboratory tests, and vital signs. All subjects will be evaluable 
for toxicity from the time of their first study treatment. Toxicities will be graded using the NCI 
CTCAE Version 5.0. or in the case of cytokine release syndrome (CRS) and CAR T-cell–related 
encephalopathy syndrome (CRES) using the specified grading system defined in the protocol. 
Efficacy 
Tumor response will be assessed by CT or MRI every 8 weeks and will be evaluated per RECIST 
Version 1.1 and iRECIST. In order to document PD, unscheduled tumor assessments may be done if 
the Investigator observes any signs and symptoms of PD. Efficacy endpoints include ORR, DOR, 
DCR, PFS, and OS. Tumor response will be based on investigator assessment. 
Exploratory Analyses 
Pharmacokinetics(phase 2 only): The PK profile of N-803 will be evaluated using validated enzyme-
linked immunosorbent assay (ELISA) methods. The PK profile of PD-L1 t-haNK will be evaluated 
using quantitative polymerase chain reaction (qPCR). 
Immunogenicity (phase 2 only): Immunogenicity (antidrug antibodies [ADA], neutralizing antibodies 
[NAb], cross-reactivity) to N-803, PD-L1 t-haNK, and sacituzumab govitecan-hziy will be evaluated 
by standard immune assays. For PD-L1 t-haNK, cellular immunogenicity will also be characterized. 
Tumor Molecular Profiling: Exploratory analyses will be conducted on tissue and blood to evaluate a 
potential biomarker signature to identify appropriate patients for the treatments tested in the trial. 
Statistical Methods: 
The phase 1b portion of the study will use a standard 3 + 3 design to determine the MTD or HTD and 
designate the RP2D. The phase 2 portion of the study will be based on Simon’s two-stage optimal 
design to evaluate the null hypothesis that the ORR is ≤ 33% tested against the one-sided alternative 
that the ORR is > 33%. 
Analysis Populations 
All subjects receiving at least 1 dose of any study drug (ie, the safety population) will be included in 
the analysis of safety and efficacy. 
In phase 1b, endpoints will be summarized for each dose level and all phase 1b subjects. 
Safety Analyses 
The rate of DLTs and the MTD (or HTD) will be assessed in phase 1b. Overall safety will be assessed 
by descriptive analyses using tabulated frequencies of AEs by grade in terms of treatment-emergent 
AEs, SAEs, and clinically significant changes in safety laboratory tests and vital signs.  
Efficacy Analyses 
The ORR and DCR will be summarized along with the 95% confidence intervals (CIs) using Clopper-
Pearson methods. DOR, PFS, and OS will be analyzed using Kaplan-Meier methods.  
Exploratory Analyses 
Correlations of tumor molecular profiles with subject outcomes will be explored. Correlations of PK 
and immunogenicity with subject outcomes and the impact of immunogenicity on PK will be explored 
in phase 2. 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
11 
Figure 1: 
Phase 1b Treatment Schema 
 
 
 
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N-803 and PD-L1 t-haNK 
ImmunityBio, Inc. 
Clinical Trial Protocol: QUILT-3.058 Version 4 
 
Confidential and Proprietary 
12 
Figure 2: 
Phase 2 Treatment Schema 
 
 
 
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