Trial Outcomes & Findings for T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive (NCT NCT02111850)
NCT ID: NCT02111850
Last Updated: 2022-03-29
Results Overview
Highest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
21 participants
Primary outcome timeframe
Before progression to next-higher dose level, at least two weeks
Results posted on
2022-03-29
Participant Flow
Participant milestones
| Measure |
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation
STARTED
|
1
|
1
|
1
|
1
|
2
|
1
|
1
|
1
|
6
|
0
|
0
|
|
Phase 1 Dose Escalation
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
6
|
0
|
0
|
|
Phase 1 Dose Escalation
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Maximum Tolerated Dose
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
|
Phase 2 Maximum Tolerated Dose
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
1
|
|
Phase 2 Maximum Tolerated Dose
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1 Dose Escalation
Participant found to be ineligible and not treated.
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-DP0401 Positive
Baseline characteristics by cohort
| Measure |
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
n=1 Participants
Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=2 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 0 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 0 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 0 • n=5 Participants
|
45.9 years
STANDARD_DEVIATION 0 • n=4 Participants
|
56.9 years
STANDARD_DEVIATION 1.56 • n=21 Participants
|
27.7 years
STANDARD_DEVIATION 0 • n=8 Participants
|
44 years
STANDARD_DEVIATION 0 • n=8 Participants
|
35.2 years
STANDARD_DEVIATION 0 • n=24 Participants
|
56.03 years
STANDARD_DEVIATION 8.08 • n=42 Participants
|
41.84 years
STANDARD_DEVIATION 15.48 • n=42 Participants
|
41.8 years
STANDARD_DEVIATION 0 • n=42 Participants
|
49.54 years
STANDARD_DEVIATION 12.69 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
2 participants
n=21 Participants
|
1 participants
n=8 Participants
|
1 participants
n=8 Participants
|
1 participants
n=24 Participants
|
6 participants
n=42 Participants
|
5 participants
n=42 Participants
|
1 participants
n=42 Participants
|
21 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Before progression to next-higher dose level, at least two weeksHighest dose at which less than or equal to 1 of 6 patients experienced a dose-limiting toxicity (DLT) (all grade 3 and greater toxicities with the exception of myelosuppression and grade 3 fever, for example) or the highest dose level studied if DLTs are not observed at any of the dose levels.
Outcome measures
| Measure |
All Participants on Phase 1
n=14 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Maximum Tolerated Cell Dose (MTD) of Cluster of Differentiation 4 (CD4) Cells Transduced With an Anti-MAGE-A3-DP0401/0402 Restricted (MAGE-A3-DP4) T Cell Receptor and Aldesleukin
|
100,000,000,000 cells
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x2 years, then per principal investigator discretion, approximately 6 yearsPopulation: One participant was not evaluable because the participant did not receive cell infusion.
Percentage of participants who have a clinical response to treatment (objective tumor regression) measured by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of the longest diameter of target lesions. Progression is at least a 20% increase in the sum of longest diameter of target lesions or the appearance of one or more new lesions. And stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
All Participants on Phase 1
n=1 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Complete Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Partial Response
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
22.2 percentage of participants
|
20 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Progression
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
77.8 percentage of participants
|
80 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants Who Have a Clinical Response to Treatment (Objective Tumor Regression)
Stable Disease
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: 6 weeks after cell infusionPopulation: There are no Grade 1 and 5 adverse events related to treatment.
Aggregate of all adverse events with Grades ≥1 that are possibly, probably, and/or definitely related to treatment. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse events.
Outcome measures
| Measure |
All Participants on Phase 1
n=1 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=2 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Lymphocyte count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Lymphopenia - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Dyspnea (shortness of breath) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Supraventricular and nodal arrhythmia: Atrial fibrillation - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Supraventricular and nodal arrhythmia: Atrial fibrillation - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Urine output decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 White blood cell decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 SGPT (Serum glutamic pyruvic transaminase) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 SGOT (Serum glutamic oxaloacetic transaminase) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Rash/desquamation - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Renal/Genitourinary - Other, renal insufficiency - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Wheezing - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 White blood cell decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Creatinine - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 SGPT (Serum glutamic pyruvic transaminase) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 SGOT (Serum glutamic oxaloacetic transaminase) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 SGOT (Serum glutamic oxaloacetic transaminase) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Anemia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
5 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Bilirubin (hyperbilirubinemia) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Confusion - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Anemia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Anorexia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Anxiety - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Blood bilirubin increased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Chills - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Colitis, infectious (e.g., Clostridium difficile) - Probable
|
0 adverse events
|
00 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Cough - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Creatinine increased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Diarrhea - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Dyspnea - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Epistaxis - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Fatigue - Probable
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Fever - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
00 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Hemoglobin - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Hypokalemia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Hypophosphatemia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Hypotension - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Hypoxia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Laryngeal hemorrhage - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Creatinine - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Creatinine - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Leukocytes (total white blood cell) - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Nasal congestion - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Nausea - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Neutrophils/granulocytes - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Pain: Head/Headache - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Platelet count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Platelets - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Dyspnea (shortness of breath) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Hemoglobin - Probable
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Pruritis - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Psychosis (hallucinations/delusions) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Hypoxia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Leukocytes (total white blood cell) - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Purpura - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Leukocytes (total white blood cell) - Probable
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Rash maculo-papular - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Lymphocyte count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Lymphopenia - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
6 adverse events
|
4 adverse events
|
1 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Lymphopenia - Probable
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 2 Rash/desquamation - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Neutrophil count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Neutrophils/granulocytes - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
6 adverse events
|
3 adverse events
|
1 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Neutrophils/granulocytes - Probable
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Platelet count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Platelets - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
6 adverse events
|
2 adverse events
|
1 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 Platelets - Probable
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
2 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 4 White blood cell decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Dyspnea (shortness of breath) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Febrile neutropenia - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Febrile neutropenia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Febrile neutropenia (fever of unknow origin) - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Febrile neutropenia (fever of unknow origin) - Probable
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
2 adverse events
|
2 adverse events
|
1 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hemoglobin - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
6 adverse events
|
6 adverse events
|
1 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hemoglobin - Probable
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
2 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hypophosphatemia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hypotension - Probable
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hypoxia - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Hypoxia - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Infection - Probable
|
1 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Leukocytes (total white blood cell) - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Lymphocyte count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
6 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Lymphopenia - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
2 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Neutrophil count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
4 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Neutrophils/granulocytes - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Neutrophils/granulocytes - Probable
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 PTT (Partial Thromboplastin Time) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Platelet count decreased - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Platelets - Definite
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
3 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Platelets - Probable
|
0 adverse events
|
1 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Potassium, serum-low (hypokalemia) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Psychosis (hallucinations/delusions) - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Rash/desquamation - Possible
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Renal failure - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Renal/Genitourinary - Other, oliguria - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
|
Number of Adverse Events With Grades ≥1 That Are Possibly, Probably, and/or Definitely Related to Treatment
Grade 3 Sodium, serum-low (hyponatremia) - Probable
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
0 adverse events
|
1 adverse events
|
0 adverse events
|
0 adverse events
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: One participant was not evaluable because the participant did not receive cell infusion. One participant was not analyzed because samples was not collected for the Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10\^8 Cells + Interleukin-2" Arm/Group.
T cell receptor (TCR) and vector presence was quantitated in peripheral blood mononuclear cells (PBMC) samples using flow cytometry. It is a process by which cells are suspended in a liquid so they can be counted.
Outcome measures
| Measure |
All Participants on Phase 1
n=1 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Engineered T Cell Receptor (TCR) Cells That Survived at 4 Weeks
|
1.0792 cells/uL
There is no full range for a single participant.
|
1.9656 cells/uL
There is no full range for a single participant.
|
2.8676 cells/uL
There is no full range for a single participant.
|
—
|
0.17248 cells/uL
There is no full range for a single participant.
|
2.8 cells/uL
There is no full range for a single participant.
|
0 cells/uL
Interval 0.0 to 0.0
|
6.79 cells/uL
There is no full range for a single participant.
|
31.9 cells/uL
Interval 2.99 to 142.1
|
84.86 cells/uL
Interval 11.32 to 158.41
|
24.95 cells/uL
There is no full range for a single participant.
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, an average of 17 monthsHere is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Outcome measures
| Measure |
All Participants on Phase 1
n=1 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=2 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 Participants
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0).
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Before progression to next-higher dose level, approximately 2 weeksA dose-limiting toxicity (DLT) is all grade 3 and greater toxicities with the exception of myelosuppression, aldesleukin expected toxicities, expected chemotherapy toxicities, immediate hypersensitivity reactions occurring within 2 hours of cell infusion, grade 3 fever, grade 3 metabolic laboratory abnormalities without significant clinical sequela that resolve within grade 2 within 7 days, and grade 3 autoimmunity that resolves to less than or equal to a grade 2 autoimmune toxicity within 10 days.
Outcome measures
| Measure |
All Participants on Phase 1
n=14 Participants
All participants treated on phase 1 dose level 1-9.
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicity (DLT)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
Serious events: 3 serious events
Other events: 6 other events
Deaths: 5 deaths
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
Serious events: 3 serious events
Other events: 5 other events
Deaths: 4 deaths
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
n=1 participants at risk
Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=2 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Gastrointestinal disorders
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Creatinine
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Hemoglobin
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Platelets
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Oliguria)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Atrial fibrillation
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
Other adverse events
| Measure |
Phase I Dose Escalation Arm 1, Dose Level 1 - 1 X 10^7 Cells + Interleukin-2
n=1 participants at risk
Arm 1 Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 2 - 3 X 10^7 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^7 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1 Dose Level 3 - 1 X 10^8 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 4 - 3 X 10^8 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^8 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 5 - 1 X 10^9 Cells + Interleukin-2
n=2 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 6 - 3 X 10^9 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^9 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 7 - 1 X 10^10 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 8 - 3 X 10^10 Cells + Interleukin-2
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 3 X 10\^10 Cells + Interleukin-2
|
Phase I Dose Escalation Arm 1, Dose Level 9 - 1 X 10^11 Cells + Interleukin-2
n=6 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes 1 X 10\^11 Cells + Interleukin-2
|
Phase 2 Arm 2, Cohort 1- Maximum Tolerated Dose + Interleukin-2 Other
n=5 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Other
|
Phase 2 Arm 2, Cohort 2 - Maximum Tolerated Dose + Interleukin-2 Melanoma
n=1 participants at risk
Anti-Melanoma antigen family A, 3-DP4 T Cell Receptor Peripheral Blood Lymphocytes Maximum Tolerated Dose + Interleukin-2 Melanoma
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 7 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
General disorders
Chills
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Creatinine
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Creatinine increased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
General disorders
Fever
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Hemoglobin
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Vascular disorders
Hypotension
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Infections and infestations
Infection
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
33.3%
2/6 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal hemorrhage
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Leukocytes (total WBC)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Lymphocytes count decreased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 11 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Lymphopenia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 8 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 5 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Nervous system disorders
Pain: Head/headache
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Platelets count decreased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 7 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Platelets
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
6/6 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 6 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
60.0%
3/5 • Number of events 3 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Oliguria)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (Renal Insufficiency)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
16.7%
1/6 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Atrial fibrillation
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/5 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
Urine output decreased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
20.0%
1/5 • Number of events 1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
|
Investigations
White blood cell decreased
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/2 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/6 • Date treatment consent signed to date off study, an average of 17 months.
|
40.0%
2/5 • Number of events 9 • Date treatment consent signed to date off study, an average of 17 months.
|
0.00%
0/1 • Date treatment consent signed to date off study, an average of 17 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place