Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Stage IV Breast Cancer (NCT NCT00791037)

Last Updated: 2017-05-25

Results Overview

Patients are monitored for the development of end organ damage by assessing adverse events with serum chemistries, liver function studies, complete blood counts, urine analysis and physical exams. All adverse events for all systems are graded on a scale of 1-5 and attribution is assigned. There are DLT criteria. DLT is defined as any incidence of Grade 3 hematologic and non-hematologic toxicity (excluding: fever, hypoxia, and urticaria) Thus, if a subject develops a Grade 3 toxicity (excluding those listed in Table 4) will be considered excessive toxicity and no further dose escalations will occur.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

23 participants

Primary outcome timeframe

Up to 4 months after first booster vaccine

Results posted on

2017-05-25

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells) Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Overall Study STARTED	23
Overall Study Primary Outcome	19
Overall Study Skeletal or Bone-only Disease by FDG-PET	1
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Vaccine Therapy+ex Vivo T Cell Expansion) n=23 Participants Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants
Region of Enrollment Canada	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 months after first booster vaccine

Population: The infusion of escalating doses of HER2 specific T cells will be defined as safe if at least 75% of subjects are able to receive all 3 infusions without dose limiting toxicity (DLT)

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy+ex Vivo-expanded T Cells) n=19 Participants Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Evaluate Toxicity of Infusing HER2-specific T Cells as Assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v3.0	0 participants

SECONDARY outcome

Timeframe: Up to 2 year following the last infusion

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy+ex Vivo-expanded T Cells) n=19 Participants Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Proportion of Patients Whose T Cells Persist at a Level the Same or Greater as the Level After the Final T Cell Infusion and Subsequent Booster Immunizations as Assessed by IFN-gamma (IFN-g) ELISPOT	15 Participants

SECONDARY outcome

Timeframe: Up to 2 years

As assessed by the development of immunity to epitopes within the HER2 protein to which the patient was not vaccinated as well as the development of immunity to other breast cancer related tumor antigens.

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy+ex Vivo-expanded T Cells) n=19 Participants Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Development of CD4+ and CD8+ Epitope Spreading	12 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Due to getting regulatory approvals we could only enroll 1 patient in this part of the protocol

Outcome measures

Outcome measures
Measure	Treatment (Vaccine Therapy+ex Vivo-expanded T Cells) n=1 Participants Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Response of Skeletal or Bone-only Disease by FDG-PET and According to European Organization for Research and Treatment for Cancer (EORTC)	1 Participants

Adverse Events

Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)

Serious events: 1 serious events

Other events: 23 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells) n=23 participants at risk Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Vascular disorders Unrelated Pulmonary Embolus	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.

Other adverse events

Other adverse events
Measure	Treatment (Vaccine Therapy+ex Vivo Expanded T Cells) n=23 participants at risk Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion. Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals. HER-2/neu peptide vaccine: Given ID leukapheresis: Undergo leukapheresis ex vivo-expanded HER2-specific T cells: Given IV cyclophosphamide: Given IV sargramostim: Given ID laboratory biomarker analysis: Correlative study
Gastrointestinal disorders Abdominal pain	13.0% 3/23 • Number of events 4 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Alkaline phos increased	8.7% 2/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	8.7% 2/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Alanine aminotransferase	13.0% 3/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Anorexia	30.4% 7/23 • Number of events 8 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Musculoskeletal and connective tissue disorders Arthralgia	26.1% 6/23 • Number of events 6 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Aspartate aminotransferase increase	34.8% 8/23 • Number of events 9 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Musculoskeletal and connective tissue disorders Back pain	13.0% 3/23 • Number of events 6 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Musculoskeletal and connective tissue disorders Bone pain	26.1% 6/23 • Number of events 17 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Hypocalcemia	21.7% 5/23 • Number of events 5 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Cardiac disorders Sinus tachycardia	4.3% 1/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Non caridac chest pain	17.4% 4/23 • Number of events 6 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Respiratory, thoracic and mediastinal disorders Cough	30.4% 7/23 • Number of events 12 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Dehydration	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Gastrointestinal disorders Constipation	34.8% 8/23 • Number of events 9 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Gastrointestinal disorders Diarrhea	30.4% 7/23 • Number of events 9 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Dry skin	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Vascular disorders Lymphedema	26.1% 6/23 • Number of events 7 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Fatigue (asthenia, lethargy, malaise)	56.5% 13/23 • Number of events 17 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)	13.0% 3/23 • Number of events 5 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Flu-like syndrome	30.4% 7/23 • Number of events 10 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Hair loss/alopecia (scalp or body)	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Nervous system disorders Head/headache	52.2% 12/23 • Number of events 25 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Blood and lymphatic system disorders Anemia	56.5% 13/23 • Number of events 24 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Vascular disorders Hot flashes/flushes	13.0% 3/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Hyperpigmentation	13.0% 3/23 • Number of events 4 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Vascular disorders Hypertension	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Infections and infestations Urinary tract infections	13.0% 3/23 • Number of events 5 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Injection site reaction	73.9% 17/23 • Number of events 52 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Psychiatric disorders Insomnia	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations White blood cell decreased	52.2% 12/23 • Number of events 17 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Lymphopenia	56.5% 13/23 • Number of events 27 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Musculoskeletal and connective tissue disorders Myalgia	39.1% 9/23 • Number of events 10 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Gastrointestinal disorders Nausea	47.8% 11/23 • Number of events 17 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Neutrophil count decreased	21.7% 5/23 • Number of events 9 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Infections and infestations Upper respiratory infection	13.0% 3/23 • Number of events 4 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Infections and infestations Lip infections	8.7% 2/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Rigors/chills	21.7% 5/23 • Number of events 10 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Eye disorders Ophthalmoplegia/diplopia (double vision)	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Hypoalbuminemia	43.5% 10/23 • Number of events 14 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Platelets	13.0% 3/23 • Number of events 4 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Hypokalemia	26.1% 6/23 • Number of events 6 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Renal and urinary disorders Proteinuria	8.7% 2/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Pruritis/itching	8.7% 2/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Rash/desquamation	17.4% 4/23 • Number of events 5 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	17.4% 4/23 • Number of events 4 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Hyponatremia	52.2% 12/23 • Number of events 17 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Ear and labyrinth disorders Tinnitus	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Gastrointestinal disorders Vomiting	13.0% 3/23 • Number of events 6 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Weight loss	8.7% 2/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Renal and urinary disorders Urinary frequency	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Diaphoresis	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Immune system disorders Allergic reaction/hypersensitivity (including drug fever)	8.7% 2/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Cardiac disorders Cardiac arrhythmia	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Investigations Creatinine	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Nervous system disorders Dizziness	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Cardiac disorders Hypotension	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Vericella zoster	8.7% 2/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Blood and lymphatic system disorders Axilla swelling/pain	4.3% 1/23 • Number of events 2 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Musculoskeletal and connective tissue disorders Muscle pain	13.0% 3/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Nervous system disorders sensory neuropathy	13.0% 3/23 • Number of events 3 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
General disorders Body aches	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Infections and infestations Pharyngitis/Rhinitis	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Injury, poisoning and procedural complications Rash: Dermatitis associated with radiation	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Skin and subcutaneous tissue disorders Erythema	4.3% 1/23 • Number of events 1 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Blood and lymphatic system disorders Blood Disorders - Not clinically significant	43.5% 10/23 • Number of events 30 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Metabolism and nutrition disorders Electrolyte Abnormalities - Not Clinically Significant	43.5% 10/23 • Number of events 20 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.
Renal and urinary disorders Non specific UA findings	47.8% 11/23 • Number of events 68 • 2 years and 6 months (Vaccine 1 through follow-up)* \*The time between leukapheresis and first T cell infusion could vary due to patients being allowed to go back on treatment or scheduling conflicts.

Additional Information

Dr. Mary L. Disis

University of Washington

Phone: 206-543-8557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place