Trial Outcomes & Findings for Dendritic Cell Vaccination in Patients With Advanced Melanoma (NCT NCT03092453)
NCT ID: NCT03092453
Last Updated: 2024-12-24
Results Overview
Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
5 participants
Primary outcome timeframe
Screening through week 21
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Mature Dendritic Cell (DC) Vaccine
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dendritic Cell Vaccination in Patients With Advanced Melanoma
Baseline characteristics by cohort
| Measure |
Mature Dendritic Cell (DC) Vaccine
n=5 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Screening through week 21Population: Antigens for each subject may be different. Outcomes were not tested past week 21.
Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.
Outcome measures
| Measure |
Subject 1
n=1 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 2
n=1 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 3
n=1 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 4
n=1 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|---|---|---|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-5, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B44-1, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, screening
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, screening
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, screening
|
0.26 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, screening
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, screening
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, Day 1
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, Day 1
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, Day 1
|
0.4 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, Day 1
|
0.48 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, Day 1
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, Day 1
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0.86 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
2.66 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
4.01 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
2.4 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, wk 14-15
|
0.32 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, wk 14-15
|
5.68 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, wk 14-15
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, wk 17
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, wk 17
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, wk 17
|
0.5 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, wk 17
|
1.81 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, wk 17
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, wk 17
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-3, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-4, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, wk 19
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, wk 19
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, wk 19
|
0.32 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, wk 19
|
0.99 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, wk 19
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, wk 19
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-1, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-2, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-5, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-6, wk 21
|
0 percent of CD8+ T cells
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-7, wk 21
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-1, wk 21
|
1.4 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-3, wk 21
|
0.16 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-4, wk 21
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B8-5, wk 21
|
0 percent of CD8+ T cells
|
—
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-2, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-3, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-4, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-5, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B44-1, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, screening
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-2, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-3, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-4, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, day 1
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, wk 14
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-2, wk 14
|
—
|
35 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-3, wk 14
|
—
|
27.2 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-4, wk 14
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-5, wk 14
|
—
|
36.5 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B44-1, wk 14
|
—
|
22.7 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, wk 14
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, wk 14
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, wk 17
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, wk 17
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, wk 17
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, wk 19
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, wk 19
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, wk 19
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-1, wk 21
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-2, wk 21
|
—
|
34.7 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-3, wk 21
|
—
|
27.7 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-4, wk 21
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B15-5, wk 21
|
—
|
33.9 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen B44-1, wk 21
|
—
|
17.4 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-1, wk 21
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A31-2, wk 21
|
—
|
0 percent of CD8+ T cells
|
—
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, screening
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-9, screening
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, screening
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, screening
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, day 1
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-9, day 1
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, day 1
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, day 1
|
—
|
—
|
0 percent of CD8+ T cells
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, wk 14
|
—
|
—
|
0 percent of CD8+ T cells
|
1.15 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-9, wk 14
|
—
|
—
|
0 percent of CD8+ T cells
|
1.08 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, wk 14
|
—
|
—
|
0 percent of CD8+ T cells
|
0.9 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, wk 14
|
—
|
—
|
10.8 percent of CD8+ T cells
|
0.14 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, wk 17
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
0Antigen A3-9, wk 17
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, wk 17
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, wk 17
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, wk 19
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-9, wk 19
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, wk 19
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, wk 19
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-8, wk 21
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-9, wk 21
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-10, wk 21
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-11, wk 21
|
—
|
—
|
0 percent of CD8+ T cells
|
—
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-12, screening
|
—
|
—
|
—
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-13, screening
|
—
|
—
|
—
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-12, day 1
|
—
|
—
|
—
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-13, day 1
|
—
|
—
|
—
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-12, wk 14
|
—
|
—
|
—
|
0 percent of CD8+ T cells
|
|
Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.
Antigen A3-13, wk 14
|
—
|
—
|
—
|
1.48 percent of CD8+ T cells
|
PRIMARY outcome
Timeframe: End of Study visit (10-28 days after last DC vaccine)Population: Safety component is entered in the Adverse Events section.
Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.
Outcome measures
| Measure |
Subject 1
n=5 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 2
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 3
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 4
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|---|---|---|
|
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Completed primary follow-up
|
3 Participants
|
—
|
—
|
—
|
|
Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).
Did not complete primary follow-up
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)using RECIST 1.1
Outcome measures
| Measure |
Subject 1
n=5 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 2
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 3
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 4
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|---|---|---|
|
Clinical Response to the mDC3/8 Vaccine(s)
Progressive disease
|
2 Participants
|
—
|
—
|
—
|
|
Clinical Response to the mDC3/8 Vaccine(s)
Not evaluable
|
3 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 weeks after the first mDC3/8 VaccinePopulation: Results are presented per subject.
based on RECIST 1.1 criteria, until occurrence of a censoring event
Outcome measures
| Measure |
Subject 1
n=5 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 2
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 3
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 4
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|---|---|---|
|
Time to Progression Post-mDC3/8 Vaccine Administration
Subject 1
|
113 days
|
—
|
—
|
—
|
|
Time to Progression Post-mDC3/8 Vaccine Administration
Subject 2
|
NA days
Subject not evaluable.
|
—
|
—
|
—
|
|
Time to Progression Post-mDC3/8 Vaccine Administration
Subject 3
|
NA days
Subject not evaluable.
|
—
|
—
|
—
|
|
Time to Progression Post-mDC3/8 Vaccine Administration
Subject 4
|
NA days
Subject not evaluable.
|
—
|
—
|
—
|
|
Time to Progression Post-mDC3/8 Vaccine Administration
Subject 5
|
80 days
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: End of Study visit (10-28 days after last DC vaccine)Population: These outcome measures are entered in the Adverse Events section.
Assessed through collection of Adverse Events.
Outcome measures
| Measure |
Subject 1
n=5 Participants
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 2
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 3
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
Subject 4
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|---|---|---|
|
Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide.
|
5 Participants
|
—
|
—
|
—
|
Adverse Events
Mature Dendritic Cell (DC) Vaccine
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mature Dendritic Cell (DC) Vaccine
n=5 participants at risk
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other (Palliative mass resection)
|
20.0%
1/5 • Number of events 2 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
Other adverse events
| Measure |
Mature Dendritic Cell (DC) Vaccine
n=5 participants at risk
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
Mature dendritic cell (DC) vaccine: Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
Cyclophosphamide 300mg/m\^2: administered prior to subject's first DC dose
Pembrolizumab: administered 7-8 weeks after subject's last DC dose
|
|---|---|
|
Cardiac disorders
Cardiac disorders - other )tachycardia)
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Gastrointestinal disorders
Abdominal Pain
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Gastrointestinal disorders
Dental Caries
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 4 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Gastrointestinal disorders
Toothache
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
General disorders
Chills
|
40.0%
2/5 • Number of events 7 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
General disorders
Fatigue
|
40.0%
2/5 • Number of events 2 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
General disorders
Flu like symptoms
|
20.0%
1/5 • Number of events 2 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Number of events 3 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Nervous system disorders
Parethesia
|
20.0%
1/5 • Number of events 3 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
1/5 • Number of events 1 • Collection of AEs will begin at the time of the first apheresis procedure (Apheresis #1) and continue until subject discontinuation or the End of Study Visit. (week 30).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place