Trial Outcomes & Findings for PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer (NCT NCT03873805)
NCT ID: NCT03873805
Last Updated: 2025-06-26
Results Overview
Grade 3 toxicity profile as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 and modified Cytokine Release Syndrome (CRS) grading as applicable post chimeric antigen receptor (CAR) T cell infusion.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Up to 32 months
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
Dose Level 1 (Starting Dose Level 1)
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
5
|
|
Overall Study
COMPLETED
|
3
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
70 years
n=7 Participants
|
69 years
n=5 Participants
|
69 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Baseline PSA (Prostate Specific Antigen)
|
16.5 ng/mL
n=5 Participants
|
88.0 ng/mL
n=7 Participants
|
235.3 ng/mL
n=5 Participants
|
88.0 ng/mL
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 32 monthsGrade 3 toxicity profile as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5 and modified Cytokine Release Syndrome (CRS) grading as applicable post chimeric antigen receptor (CAR) T cell infusion.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Grade 3 Toxicity Profile
Pain : No
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Cystitis noninfective : Yes
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Grade 3 Toxicity Profile
Cystitis noninfective : No
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Hematuria : Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Toxicity Profile
Hematuria : No
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Rash maculo-papular : Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Grade 3 Toxicity Profile
Rash maculo-papular : No
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Anemia : Yes
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Grade 3 Toxicity Profile
Anemia : No
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Lymphocyte count decreased : Yes
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Grade 3 Toxicity Profile
Lymphocyte count decreased : No
|
2 Participants
|
6 Participants
|
4 Participants
|
|
Grade 3 Toxicity Profile
Fatigue : Yes
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Grade 3 Toxicity Profile
Fatigue : No
|
3 Participants
|
4 Participants
|
5 Participants
|
|
Grade 3 Toxicity Profile
Pain : Yes
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 28 days post treatmentDefined by any grade 3 or NCI CTCAE toxicities and modified CRS grading as applicable.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 28 post infusionPersistence is defined as CAR T cells comprising at least 7.5 copies/ug of DNA of total CD3 cells.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Percent of Participants With CAR T Cells Persistence at Day 28
|
66 Percent of participants
Interval 9.0 to 99.0
|
66 Percent of participants
Interval 22.0 to 96.0
|
60 Percent of participants
Interval 15.0 to 95.0
|
SECONDARY outcome
Timeframe: Up to 28 days post treatmentPeak expansion (max log10 copies/ug of genomic deoxyribonucleic acid \[DNA\]) will be described.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Expansion of CAR T Cells
|
2.1 log10 copies/ug of DNA
Interval 1.6 to 2.6
|
3.3 log10 copies/ug of DNA
Interval 2.5 to 4.0
|
2.8 log10 copies/ug of DNA
Interval 2.3 to 3.4
|
SECONDARY outcome
Timeframe: Up to 1 year post treatmentRates and associated 90% Clopper and Pearson binomial confidence limits will be estimated for response based on Prostate Cancer Working Group 3 (PCWG3) criteria.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Percent of Participants Achieving Stable Disease
|
0 percentage of participants
Interval 0.0 to 71.0
|
67 percentage of participants
Interval 22.0 to 96.0
|
60 percentage of participants
Interval 15.0 to 95.0
|
SECONDARY outcome
Timeframe: From CAR T cell infusion to death from any cause or last contact date, assessed up to 6 monthsRates and associated 95% exact Clopper and Pearson binomial confidence intervals will be estimated.
Outcome measures
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 Participants
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 Participants
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 Participants
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Percent of Participants Alive at Six Months
|
33 Percentage of participants
Interval 1.0 to 91.0
|
67 Percentage of participants
Interval 22.0 to 96.0
|
40 Percentage of participants
Interval 5.0 to 85.0
|
Adverse Events
Dose Level 1 (Starting Dose Level 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 3 deaths
Dose Level 2 (Dose Level 1b)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 6 deaths
Dose Level 3 (Dose Level 1d)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 participants at risk
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 participants at risk
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 participants at risk
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
General disorders
Generalized edema
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Immune system disorders
CRS
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
Other adverse events
| Measure |
Dose Level 1 (Starting Dose Level 1)
n=3 participants at risk
100 million CAR T+ cells
|
Dose Level 2 (Dose Level 1b)
n=6 participants at risk
100 million CAR T+ cells plus lymphodepletion
Cyclophosphamide: 500 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
Dose Level 3 (Dose Level 1d)
n=5 participants at risk
100 million CAR T+ cells plus modified lymphodepletion
Cyclophosphamide: 300 mg/m2 Given IV
Fludarabine: 30 mg/m2 Given IV
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
3/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Cardiac disorders
Sinus bradycardia
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Cardiac disorders
Sinus tachycardia
|
66.7%
2/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
Eye disorders
Blurred vision
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Eye disorders
Dry eye
|
66.7%
2/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Eye disorders
Photophobia
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Eye disorders
Periorbital edema
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Eye disorders
blepharoconjuctivitis
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Eye disorders
corneal abrasion
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Eye disorders
left sided subconjuctival hemorrhage
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Ascites
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Constipation
|
66.7%
2/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Dental caries
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Fecal incontinence
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Flatulence
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
3/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
General disorders
Chills
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
General disorders
Fatigue
|
66.7%
2/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
General disorders
Fever
|
33.3%
1/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
General disorders
Gait disturbance
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
General disorders
Generalized edema
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
General disorders
Malaise
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
General disorders
Pain
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
General disorders
Edema limbs
|
33.3%
1/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
General disorders
Localized edema
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Immune system disorders
CRS
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Immune system disorders
Immune reaction
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Infections and infestations
Conjunctivitis
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Infections and infestations
Enterocolitis infectious
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Infections and infestations
Papulopustular rash
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Injury, poisoning and procedural complications
Bruising
|
33.3%
1/3 • While on study, up to 3 years
|
83.3%
5/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Investigations
Cardiac troponin T increased
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Creatinine increased
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Lymphocyte count decreased
|
33.3%
1/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
Investigations
Thyroid stimulating hormone increased
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Weight gain
|
66.7%
2/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Investigations
Weight loss
|
33.3%
1/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Investigations
Lip sweling
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Investigations
night sweats
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
66.7%
2/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
66.7%
2/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
100.0%
3/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
66.7%
2/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
66.7%
2/3 • While on study, up to 3 years
|
83.3%
5/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle cramp
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
66.7%
2/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • While on study, up to 3 years
|
66.7%
4/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Psychiatric disorders
Restlessness
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Dysuria
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Hematuria
|
66.7%
2/3 • While on study, up to 3 years
|
83.3%
5/6 • While on study, up to 3 years
|
80.0%
4/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Proteinuria
|
66.7%
2/3 • While on study, up to 3 years
|
83.3%
5/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Urinary frequency
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Urinary retention
|
66.7%
2/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Bladder spasm
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Urinary tract pain
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Glucosuria
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
60.0%
3/5 • While on study, up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Reproductive system and breast disorders
Penile pain
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
66.7%
2/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • While on study, up to 3 years
|
33.3%
2/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
66.7%
2/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
20.0%
1/5 • While on study, up to 3 years
|
|
Skin and subcutaneous tissue disorders
skin tear
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • While on study, up to 3 years
|
16.7%
1/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
|
Vascular disorders
Hypertension
|
100.0%
3/3 • While on study, up to 3 years
|
100.0%
6/6 • While on study, up to 3 years
|
100.0%
5/5 • While on study, up to 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • While on study, up to 3 years
|
50.0%
3/6 • While on study, up to 3 years
|
40.0%
2/5 • While on study, up to 3 years
|
|
Vascular disorders
Thromboembolic event
|
33.3%
1/3 • While on study, up to 3 years
|
0.00%
0/6 • While on study, up to 3 years
|
0.00%
0/5 • While on study, up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place