Trial Outcomes & Findings for DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma (NCT NCT01353222)

Last Updated: 2017-05-25

Results Overview

Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

142 participants

Primary outcome timeframe

Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)

Results posted on

2017-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	DN24-02 DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Overall Study STARTED	70	72
Overall Study DN24-02 Arm ≥1 Leukapheresis	67	0
Overall Study Standard Care Arm ≥1 Post-baseline Visit	0	72
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	70	72

Reasons for withdrawal

Reasons for withdrawal
Measure	DN24-02 DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Overall Study Death	30	30
Overall Study Withdrawal by Subject	8	5
Overall Study Study Terminated	31	37
Overall Study Site closed research department	1	0

Baseline Characteristics

Baseline weight for one subject in standard of care group is missing.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DN24-02 n=70 Participants DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care n=72 Participants Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=70 Participants	0 Participants n=72 Participants	0 Participants n=142 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=70 Participants	35 Participants n=72 Participants	68 Participants n=142 Participants
Age, Categorical >=65 years	37 Participants n=70 Participants	37 Participants n=72 Participants	74 Participants n=142 Participants
Age, Continuous	65.6 years STANDARD_DEVIATION 10.81 • n=70 Participants	66.4 years STANDARD_DEVIATION 10.09 • n=72 Participants	66.0 years STANDARD_DEVIATION 10.42 • n=142 Participants
Sex: Female, Male Female	18 Participants n=70 Participants	19 Participants n=72 Participants	37 Participants n=142 Participants
Sex: Female, Male Male	52 Participants n=70 Participants	53 Participants n=72 Participants	105 Participants n=142 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=70 Participants	0 Participants n=72 Participants	0 Participants n=142 Participants
Race (NIH/OMB) Asian	1 Participants n=70 Participants	2 Participants n=72 Participants	3 Participants n=142 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=70 Participants	0 Participants n=72 Participants	0 Participants n=142 Participants
Race (NIH/OMB) Black or African American	4 Participants n=70 Participants	0 Participants n=72 Participants	4 Participants n=142 Participants
Race (NIH/OMB) White	65 Participants n=70 Participants	70 Participants n=72 Participants	135 Participants n=142 Participants
Race (NIH/OMB) More than one race	0 Participants n=70 Participants	0 Participants n=72 Participants	0 Participants n=142 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=70 Participants	0 Participants n=72 Participants	0 Participants n=142 Participants
Region of Enrollment United States	70 Participants n=70 Participants	72 Participants n=72 Participants	142 Participants n=142 Participants
Body weight	80.770 kilograms STANDARD_DEVIATION 18.3080 • n=70 Participants • Baseline weight for one subject in standard of care group is missing.	82.115 kilograms STANDARD_DEVIATION 17.9330 • n=71 Participants • Baseline weight for one subject in standard of care group is missing.	81.448 kilograms STANDARD_DEVIATION 18.0679 • n=141 Participants • Baseline weight for one subject in standard of care group is missing.
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 0=Fully Active; No restrictions	42 Participants n=69 Participants • Baseline ECOG data is missing for one subject in each group.	38 Participants n=71 Participants • Baseline ECOG data is missing for one subject in each group.	80 Participants n=140 Participants • Baseline ECOG data is missing for one subject in each group.
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 1= Restricted Strenuous Activity	24 Participants n=69 Participants • Baseline ECOG data is missing for one subject in each group.	31 Participants n=71 Participants • Baseline ECOG data is missing for one subject in each group.	55 Participants n=140 Participants • Baseline ECOG data is missing for one subject in each group.
Eastern Cooperative Oncology Group (ECOG) Performance Status ECOG 2=Ambulatory, capable of self-care; no work	3 Participants n=69 Participants • Baseline ECOG data is missing for one subject in each group.	2 Participants n=71 Participants • Baseline ECOG data is missing for one subject in each group.	5 Participants n=140 Participants • Baseline ECOG data is missing for one subject in each group.

PRIMARY outcome

Timeframe: Subjects will be followed from baseline through the remainder of their lives or until study completion (approximately 60 months)

Population: Intent to Treat (ITT) population. \*This study was terminated early due to administrative reasons.

Overall survival is defined as the time from randomization to death due to any cause. \*This study was terminated early due to administrative reasons.

Outcome measures

Outcome measures
Measure	DN24-02 n=70 Participants DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care n=72 Participants Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population. Standard of Care: Standard of care
Overall Survival	17.2 Months Interval 0.1 to 42.4	18 Months Interval 0.3 to 40.2

Adverse Events

DN24-02

Serious events: 20 serious events

Other events: 64 other events

Deaths: 30 deaths

Standard of Care

Serious events: 17 serious events

Other events: 52 other events

Deaths: 30 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 presentation 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

Serious adverse events
Measure	DN24-02 n=67 participants at risk DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care n=72 participants at risk Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Blood and lymphatic system disorders ANAEMIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Cardiac disorders CARDIAC FAILURE ACUTE	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Cardiac disorders CARDIOGENIC SHOCK	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	3.0% 2/67 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders ABDOMINAL PAIN	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders NAUSEA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders VOMITING	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders GASTROINTESTINAL NECROSIS	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders INTESTINAL PERFORATION	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders ASTHENIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders DEVICE DISLOCATION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders FATIGUE	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders MEDICAL DEVICE COMPLICATION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders PYREXIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations ESCHERICHIA SEPSIS	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations INFECTION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations LUNG INFECTION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations PYELONEPHRITIS SEPSIS	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations SEPSIS	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations URINARY TRACT INFECTION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations UROSEPSIS	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Injury, poisoning and procedural complications GASTROINTESTINAL STOMA COMPLICATION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Injury, poisoning and procedural complications INCISIONAL HERNIA	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Injury, poisoning and procedural complications THORACIC VERTEBRAL FRACTURE	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Investigations MEDICAL OBSERVATION	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Metabolism and nutrition disorders HYPONATRAEMIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders ARTHRALGIA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders BACK PAIN	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) FOLLICLE CENTRE LYMPHOMA, FOLLICULAR GRADE I, II, III	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC NEOPLASM MALIGNANT	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE CARCINOMA	1.5% 1/67 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	0.00% 0/72 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.

Other adverse events
Measure	DN24-02 n=67 participants at risk DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.	Standard of Care n=72 participants at risk Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
Blood and lymphatic system disorders ANAEMIA	11.9% 8/67 • Number of events 8 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	6.9% 5/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders CONSTIPATION	20.9% 14/67 • Number of events 15 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	13.9% 10/72 • Number of events 10 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders NAUSEA	26.9% 18/67 • Number of events 27 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	8.3% 6/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders ABDOMINAL PAIN	13.4% 9/67 • Number of events 9 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	12.5% 9/72 • Number of events 9 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders VOMITING	14.9% 10/67 • Number of events 17 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	9.7% 7/72 • Number of events 7 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders DIARRHOEA	17.9% 12/67 • Number of events 13 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/67 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders FATIGUE	38.8% 26/67 • Number of events 36 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	20.8% 15/72 • Number of events 17 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders CHILLS	35.8% 24/67 • Number of events 37 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders PYREXIA	25.4% 17/67 • Number of events 20 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	6.9% 5/72 • Number of events 10 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders OEDEMA PERIPHERAL	10.4% 7/67 • Number of events 9 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	4.2% 3/72 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders PAIN	10.4% 7/67 • Number of events 10 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
General disorders INFLUENZA LIKE ILLNESS	6.0% 4/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations URINARY TRACT INFECTION	9.0% 6/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	12.5% 9/72 • Number of events 25 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations NASOPHARYNGITIS	10.4% 7/67 • Number of events 7 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	6.9% 5/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	6.0% 4/67 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Investigations WEIGHT DECREASED	9.0% 6/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Investigations BLOOD CREATININE INCREASED	3.0% 2/67 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders BACK PAIN	20.9% 14/67 • Number of events 15 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	8.3% 6/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders ARTHRALGIA	11.9% 8/67 • Number of events 9 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	13.9% 10/72 • Number of events 14 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	7.5% 5/67 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	9.7% 7/72 • Number of events 8 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders FLANK PAIN	6.0% 4/67 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	6.9% 5/72 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	9.0% 6/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	7.5% 5/67 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	4.2% 3/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Nervous system disorders HEADACHE	19.4% 13/67 • Number of events 16 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Nervous system disorders DIZZINESS	7.5% 5/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Nervous system disorders NEUROPATHY PERIPHERAL	7.5% 5/67 • Number of events 8 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Psychiatric disorders INSOMNIA	6.0% 4/67 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Renal and urinary disorders HAEMATURIA	10.4% 7/67 • Number of events 8 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	8.3% 6/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Renal and urinary disorders INCONTINENCE	3.0% 2/67 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Respiratory, thoracic and mediastinal disorders COUGH	14.9% 10/67 • Number of events 10 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	8.3% 6/72 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	6.0% 4/67 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	2.8% 2/72 • Number of events 2 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Skin and subcutaneous tissue disorders PRURITUS	4.5% 3/67 • Number of events 4 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	5.6% 4/72 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Skin and subcutaneous tissue disorders RASH	9.0% 6/67 • Number of events 6 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.
Vascular disorders HYPOTENSION	6.0% 4/67 • Number of events 5 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.	1.4% 1/72 • Number of events 1 • Adverse events were collected from the time of registration through investigator-assessed disease recurrence or 30 days following the final infusion of DN24-02, whichever occurred later. Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.