Trial Outcomes & Findings for To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen (NCT NCT00715078)

Last Updated: 2017-05-23

Results Overview

An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusions were included.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

122 participants

Primary outcome timeframe

Baseline, Months 2, 4 and 6.

Results posted on

2017-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort B Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort C Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Overall Study STARTED	41	40	41
Overall Study Received ≥ 1 Study Infusion	40	40	39
Overall Study Received ≥ 1 Leukapheresis	40	40	40
Overall Study COMPLETED	11	4	3
Overall Study NOT COMPLETED	30	36	38

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort B Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort C Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Overall Study Death	29	36	36
Overall Study Withdrawal by Subject	1	0	1
Overall Study Unable to start due to disease prog.	0	0	1

Baseline Characteristics

To Evaluate Sipuleucel-T Manufactured With Different Concentrations of (PA2024) Antigen

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline, Months 2, 4 and 6.

Population: Cumulative CD54 upregulation ratio will be the primary end point and calculated as the sum of Infusion 1 through Infusion 3 final product values for each infused subject.

Outcome measures

Outcome measures
Measure	Cohort A n=40 Participants Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort B n=36 Participants Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort C n=37 Participants Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
Cumulative CD54 Upregulation Ratio Between Each of the Cohorts.	29.53 Ratio ofCD54 molecules on BDS65:FP cells Standard Error 1.285	30.94 Ratio ofCD54 molecules on BDS65:FP cells Standard Error 1.418	26.67 Ratio ofCD54 molecules on BDS65:FP cells Standard Error 1.194

Adverse Events

Cohort A

Serious events: 10 serious events

Other events: 38 other events

Deaths: 29 deaths

Cohort B

Serious events: 9 serious events

Other events: 40 other events

Deaths: 36 deaths

Cohort C

Serious events: 11 serious events

Other events: 40 other events

Deaths: 36 deaths

Serious adverse events

Other adverse events

Additional Information

Shabnam Vaziri

Dendreon

Phone: 206-455-2323

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The results of the Study will be published and/or presented in an integrated manner reflecting the results observed across all participating centers. Accordingly, decisions on timing and content of publications and presentations relating to the Study will be coordinated by Dendreon in communication with institutions contributing patients to the Study.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A n=41 Participants Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort B n=40 Participants Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Cohort C n=41 Participants Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL. Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	30 Participants n=5 Participants	31 Participants n=7 Participants	30 Participants n=5 Participants	91 Participants n=4 Participants
Age, Continuous	71.0 years STANDARD_DEVIATION 8.25 • n=5 Participants	71.8 years STANDARD_DEVIATION 8.29 • n=7 Participants	68.6 years STANDARD_DEVIATION 7.5 • n=5 Participants	70.5 years STANDARD_DEVIATION 8.07 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	40 Participants n=7 Participants	41 Participants n=5 Participants	122 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	35 Participants n=7 Participants	38 Participants n=5 Participants	111 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	41 Participants n=5 Participants	40 Participants n=7 Participants	41 Participants n=5 Participants	122 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 0=Fully Active; No restrictions	29 Participants n=5 Participants	24 Participants n=7 Participants	27 Participants n=5 Participants	80 Participants n=4 Participants
Eastern Cooperative Oncology Group (ECOG) performance status ECOG 1= Restricted Strenuous Activity	12 Participants n=5 Participants	16 Participants n=7 Participants	14 Participants n=5 Participants	42 Participants n=4 Participants
Gleason Score Gleason Score ≤ 6	7 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants
Gleason Score Gleason Score =7	12 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	41 Participants n=4 Participants
Gleason Score Gleason Score ≥ 8	22 Participants n=5 Participants	16 Participants n=7 Participants	23 Participants n=5 Participants	61 Participants n=4 Participants
Gleason Score Missing information	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

Serious adverse events
Measure	Cohort A n=40 participants at risk Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL	Cohort B n=40 participants at risk Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL	Cohort C n=40 participants at risk Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL
Blood and lymphatic system disorders ANAEMIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders ANGINA PECTORIS	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders ATRIAL FIBRILLATION	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders ATRIOVENTRICULAR BLOCK COMPLETE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders ATRIOVENTRICULAR BLOCK SECOND DEGREE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders BRADYCARDIA	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Ear and labyrinth disorders VERTIGO	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders ILEUS	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders ASTHENIA	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders CHILLS	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders DISEASE PROGRESSION	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders FATIGUE	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders PYREXIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations BACTERAEMIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations DEVICE RELATED INFECTION	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations PNEUMONIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations SEPSIS	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations UROSEPSIS	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications CERVICAL VERTEBRAL FRACTURE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications WOUND	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders HYPERGLYCAEMIA	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders HYPOCALCAEMIA	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders CEREBRAL INFARCTION	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders CEREBROVASCULAR ACCIDENT	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders INTRACRANIAL TUMOUR HAEMORRHAGE	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders SPINAL CORD COMPRESSION	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders SYNCOPE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Psychiatric disorders CONFUSIONAL STATE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.

Other adverse events
Measure	Cohort A n=40 participants at risk Sipuleucel-T with the concentration of 10 μg/mL PA2024 in a cell suspension of 1 x 10\^7 peripheral blood mononuclear cells (PBMCs) per mL	Cohort B n=40 participants at risk Sipuleucel-T with the concentration of 5 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL	Cohort C n=40 participants at risk Sipuleucel-T with the concentration of 2 μg/mL PA2024 in a cell suspension of 1 x 10\^7 PBMCs per mL
Blood and lymphatic system disorders ANAEMIA	15.0% 6/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	20.0% 8/40 • Number of events 8 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders ABDOMINAL PAIN	10.0% 4/40 • Number of events 4 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders CONSTIPATION	22.5% 9/40 • Number of events 10 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	20.0% 8/40 • Number of events 9 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	15.0% 6/40 • Number of events 7 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders DIARRHOEA	10.0% 4/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 4 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders DYSPEPSIA	10.0% 4/40 • Number of events 4 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders DYSPHAGIA	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders FLATULENCE	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders NAUSEA	40.0% 16/40 • Number of events 20 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	27.5% 11/40 • Number of events 11 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	27.5% 11/40 • Number of events 12 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders RETCHING	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Gastrointestinal disorders VOMITING	20.0% 8/40 • Number of events 9 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	12.5% 5/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	12.5% 5/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders ASTHENIA	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders CHEST DISCOMFORT	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders CHEST PAIN	15.0% 6/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders CHILLS	22.5% 9/40 • Number of events 15 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	32.5% 13/40 • Number of events 25 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	25.0% 10/40 • Number of events 15 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders FATIGUE	50.0% 20/40 • Number of events 23 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	50.0% 20/40 • Number of events 27 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	40.0% 16/40 • Number of events 17 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders INFLUENZA LIKE ILLNESS	10.0% 4/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders MALAISE	2.5% 1/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders OEDEMA PERIPHERAL	15.0% 6/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	22.5% 9/40 • Number of events 10 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders PAIN	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
General disorders PYREXIA	12.5% 5/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	17.5% 7/40 • Number of events 8 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations BRONCHITIS	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations GASTROENTERITIS VIRAL	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations NASOPHARYNGITIS	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations PNEUMONIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	5.0% 2/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations URINARY TRACT INFECTION	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	12.5% 5/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Infections and infestations VIRAL INFECTION	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications CITRATE TOXICITY	12.5% 5/40 • Number of events 10 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 7 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	15.0% 6/40 • Number of events 13 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications CONTUSION	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications FALL	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 4 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Injury, poisoning and procedural complications LACERATION	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Investigations BLOOD PRESSURE INCREASED	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	2.5% 1/40 • Number of events 1 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 7 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Investigations WEIGHT DECREASED	17.5% 7/40 • Number of events 7 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	12.5% 5/40 • Number of events 5 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	7.5% 3/40 • Number of events 3 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders DECREASED APPETITE	17.5% 7/40 • Number of events 8 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	25.0% 10/40 • Number of events 10 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	20.0% 8/40 • Number of events 8 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders DEHYDRATION	20.0% 8/40 • Number of events 12 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 8 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	10.0% 4/40 • Number of events 6 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	5.0% 2/40 • Number of events 2 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.	0.00% 0/40 • Baseline visit and at each visit through Month 6, or the initiation of an anticancer intervention, whichever occurs first. Following Month 6 (or the initiation of an anticancer intervention), treatment-related adverse events will be collected until death. All cerebrovascular events occurring throughout the study (regardless of causality) were reported. Adverse events are reported in the safety population defined as subjects that received ≥ 1 leukapheresis.