Trial Outcomes & Findings for CT Antigen TCR-redirected T Cells for Ovarian Cancer. (NCT NCT01567891)
NCT ID: NCT01567891
Last Updated: 2019-06-27
Results Overview
Number of Participants with Adverse Events related to study treatment
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Up to 12 months
Results posted on
2019-06-27
Participant Flow
Participant milestones
| Measure |
NY-ESO-1ᶜ²⁵⁹T Cells Administered Intravenously
Participants who received cytoreductive chemotherapy followed by Lentivirus-mediated genetically engineered NY-ESO-1ᶜ²⁵⁹T (Target dose: 5 billion cells)
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
Received T-cell
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CT Antigen TCR-redirected T Cells for Ovarian Cancer.
Baseline characteristics by cohort
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 Participants
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=39 Participants
|
|
Age, Continuous
|
58 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to 12 monthsPopulation: Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Number of Participants with Adverse Events related to study treatment
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 Participants
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
Week 4 Post-treatment- Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Manufactured Product - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 4 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|---|---|---|---|---|
|
Adverse Events Related to Study Treatment
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Change from baseline, every 4 weeks until month 3 and then every 3 month until disease progressionPopulation: Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Number of participants with response as assessed by Immune-related Response Criteria (irRC)
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 Participants
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
Week 4 Post-treatment- Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Manufactured Product - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 4 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|---|---|---|---|---|
|
Tumor Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days: 1, 2-4, weeks 1 to 4, Week 8, 12 and Month 6, then every 3 months thereafter until progression then during LTFUPopulation: Participants who received NY-ESO-1ᶜ²⁵⁹T
Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 Participants
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
Week 4 Post-treatment- Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Manufactured Product - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 4 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|---|---|---|---|---|
|
Peak Persistence of Modified T-cells in the Peripheral Blood
|
85862.6 copies of WPRE/mcg of genomic PBMC DNA
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 4 and 8 post T-cell infusionPercentage of CD4+pentamer+ or CD8+pentamer+ cells expressing LAG-3, PD-1, TIM-3 in the functionality of NY-ESO-1ᶜ²⁵⁹T cells in the manufactured product and post-treatment blood.
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=3 T-cell sub population
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
Week 4 Post-treatment- Mean % CD4+Pentamer+
n=3 T-cell sub population
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD4+Pentamer+
n=3 T-cell sub population
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Manufactured Product - Mean % CD8+Pentamer+
n=3 T-cell sub population
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 4 Post-treatment - Mean % CD8+Pentamer+
n=3 T-cell sub population
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD8+Pentamer+
n=3 T-cell sub population
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|---|---|---|---|---|
|
Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.
%LAG-3
|
4 percentage of T cell sub population
|
3 percentage of T cell sub population
|
0 percentage of T cell sub population
|
3 percentage of T cell sub population
|
0 percentage of T cell sub population
|
0 percentage of T cell sub population
|
|
Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.
%PD-1
|
6 percentage of T cell sub population
|
0 percentage of T cell sub population
|
3 percentage of T cell sub population
|
1 percentage of T cell sub population
|
1 percentage of T cell sub population
|
4 percentage of T cell sub population
|
|
Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood.
%TIM-3
|
97 percentage of T cell sub population
|
17 percentage of T cell sub population
|
11 percentage of T cell sub population
|
97 percentage of T cell sub population
|
24 percentage of T cell sub population
|
7 percentage of T cell sub population
|
SECONDARY outcome
Timeframe: Screening and at BaselinePopulation: Data is presented for 2 subjects, 4 subjects declined Baseline biopsy or biopsy wasn't collected due to safety concerns
NY-ESO-1 expression as determined by Histoscore (H score). Histoscore (0-300) represents the amount of NY-ESO-1 protein present in the tissue sample. H-Score formula: \[1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)\] (It is not clearly established if NY-ESO-1 H score has an association with prognosis.)
Outcome measures
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=1 Participants
Participants who received cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T.
|
Week 4 Post-treatment- Mean % CD4+Pentamer+
n=1 Participants
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD4+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Manufactured Product - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 4 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Week 8 Post-treatment - Mean % CD8+Pentamer+
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|---|---|---|---|---|
|
Correlate NY-ESO-1 Expression in Tumor Tissue Before Treatment With Archival Tumor Tissue to Assess Impact of Therapy on Expression of NY-ESO-1 Protein
Screening/Archival
|
50 H score
|
100 H score
|
—
|
—
|
—
|
—
|
|
Correlate NY-ESO-1 Expression in Tumor Tissue Before Treatment With Archival Tumor Tissue to Assess Impact of Therapy on Expression of NY-ESO-1 Protein
Baseline
|
15 H score
|
0 H score
|
—
|
—
|
—
|
—
|
Adverse Events
NY-ESO-1ᶜ²⁵⁹T
Serious events: 5 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 participants at risk
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
3/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Immune system disorders
Cytokine Release Syndrome
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Disease Progression
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Pancytopenia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Pyrexia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Other adverse events
| Measure |
NY-ESO-1ᶜ²⁵⁹T
n=6 participants at risk
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|---|---|
|
Investigations
White blood cell count decreased
|
100.0%
6/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Neutrophil count decreased
|
83.3%
5/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Abdominal Pain
|
50.0%
3/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
3/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
50.0%
3/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Ascites
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Psychiatric disorders
Confusional state
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Cardiac disorders
Sinus Tachycardia
|
33.3%
2/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Anal incontinence
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Asparate aminotransferase increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Chills
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Immune system disorders
Conjunctivitis
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Facial Pain
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hypernatremia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Lymphademopathy
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Lymphopenia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Malaise
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Infections and infestations
Mucosal infection
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
General disorders
Edema
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Nervous system disorders
Presyncope
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Renal and urinary disorders
Proteinuria
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Serum ferritin increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Investigations
Troponin increased
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Upper airway cough syndrome
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Infections and infestations
Vulvovaginal candidiasis
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
16.7%
1/6 • Number of events 6 • Start of lymphodepletion to end of intervention phase (up to 12 months post T-cell infusion)
Participants who received NY-ESO-1ᶜ²⁵⁹T
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60