Trial Outcomes & Findings for T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer (NCT NCT01967823)
NCT ID: NCT01967823
Last Updated: 2021-03-24
Results Overview
Percentage of patients who have a clinical response (complete response or partial response) to treatment (objective tumor regression). Response was determined entirely by radiographic imaging using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 to compare target lesions in centimeters. Complete Response is defined as disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2, then per principal investigator (PI) discretion, up to five years or disease progression.
Results posted on
2021-03-24
Participant Flow
Participant milestones
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
|---|---|
|
Overall Study
Died prior to completing therapy (before the six-week mark).
|
1
|
Baseline Characteristics
T Cell Receptor Immunotherapy Targeting NY-ESO-1 for Patients With NY-ESO-1 Expressing Cancer
Baseline characteristics by cohort
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=11 Participants
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
41.43 years
STANDARD_DEVIATION 11.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2, then per principal investigator (PI) discretion, up to five years or disease progression.Population: One participant was not evaluable in terms of response.
Percentage of patients who have a clinical response (complete response or partial response) to treatment (objective tumor regression). Response was determined entirely by radiographic imaging using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.0 to compare target lesions in centimeters. Complete Response is defined as disappearance of all target lesions. Partial Response is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Outcome measures
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=10 Participants
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 3 (± 1) Months
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 3 (±
1\) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 6 (± 2) Months
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 6 (± 2) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at ≥ 1 Year
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at ≥ 1 Year
|
|---|---|---|---|---|
|
Percentage of Participants With a Response
Complete Response
|
10 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With a Response
Partial Response
|
50 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 and 6 months, and 1 year post cell administrationPopulation: Because so few patients were still on study at later time points, we felt it was more relevant to show the raw data rather than provide summary values (median, range) that could be more misleading with small numbers. Reasons participants were not analyzed: 1010004 was determined to be scientifically non-evaluable, 1010011 at 3 (± 1) mo. did not have a sample available within the time frame, and all other NA noted, were not done secondary to disease progression and/or expiration.
T Cell Receptor (TCR) and vector presence will be quantitated in peripheral blood mononuclear cells (PBMC) samples using established polymerase chain reaction (PCR) techniques.
Outcome measures
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=9 Participants
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 3 (± 1) Months
n=8 Participants
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 3 (±
1\) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 6 (± 2) Months
n=6 Participants
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 6 (± 2) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at ≥ 1 Year
n=2 Participants
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at ≥ 1 Year
|
|---|---|---|---|---|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010001
|
81 Percentage of Tcells
|
1.93 Percentage of Tcells
|
—
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010002
|
83 Percentage of Tcells
|
40.9 Percentage of Tcells
|
—
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010003
|
76.4 Percentage of Tcells
|
16.1 Percentage of Tcells
|
7.15 Percentage of Tcells
|
0.87 Percentage of Tcells
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010006
|
87.3 Percentage of Tcells
|
16.1 Percentage of Tcells
|
7.15 Percentage of Tcells
|
0.87 Percentage of Tcells
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010007
|
80 Percentage of Tcells
|
44 Percentage of Tcells
|
—
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010008
|
86.7 Percentage of Tcells
|
16.9 Percentage of Tcells
|
0.28 Percentage of Tcells
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010009
|
82 Percentage of Tcells
|
31.8 Percentage of Tcells
|
18.4 Percentage of Tcells
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010010
|
68.4 Percentage of Tcells
|
0.37 Percentage of Tcells
|
0.32 Percentage of Tcells
|
—
|
|
Percentage of T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells
1010011
|
78.2 Percentage of Tcells
|
—
|
46.2 Percentage of Tcells
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to approximately 6 weeks following cell administration.Here is the count 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 |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=11 Participants
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 3 (± 1) Months
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 3 (±
1\) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at 6 (± 2) Months
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at 6 (± 2) Months
|
T Cell Receptor (TCR) in Cluster of Differentiation 3 (CD3) + Cells at ≥ 1 Year
T Cell Receptor (TCR) in Cluster of differentiation 3 (CD3) + cells at ≥ 1 Year
|
|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Treatment Related Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
11 Participants
|
—
|
—
|
—
|
Adverse Events
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
Serious events: 4 serious events
Other events: 11 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=11 participants at risk
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
|---|---|
|
Metabolism and nutrition disorders
Acidosis
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Renal and urinary disorders
Acute kidney injury
|
9.1%
1/11 • Number of events 5 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Blood and lymphatic system disorders
Blood bilirubin increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Psychiatric disorders
Confusion
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Nervous system disorders
Depressed level of consciousness
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.2%
2/11 • Number of events 3 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Cardiac disorders
Ejection fraction decreased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Neutrophil count decreased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Platelet count decreased
|
9.1%
1/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia::Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Renal and urinary disorders
Urine output decreased
|
9.1%
1/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
White blood cell decreased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
Other adverse events
| Measure |
Lymphodepleting Conditioning Foll/by Infusion of Anti-NY ESO1 Murine TCR-Gene Engineered Lymphocytes
n=11 participants at risk
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + anti-ESO murine T-cell receptor (TCR) transduced peripheral blood lymphocytes (PBL) + high-dose aldesleukin
Anti-NY ESO-1 mTCR PBL: Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
Cyclophosphamide: Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
Fludarabine: Days -7 to -3: Fludarabine 25 mg /m\^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
Aldesleukin: Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
|
|---|---|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Immune system disorders
Allergic reaction
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Blood and lymphatic system disorders
Anemia
|
36.4%
4/11 • Number of events 19 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Anorexia
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Cardiac disorders
Atrial fibrillation
|
9.1%
1/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Cardiac disorders
Atrial flutter
|
9.1%
1/11 • Number of events 3 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
27.3%
3/11 • Number of events 3 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
CPK increased
|
9.1%
1/11 • Number of events 4 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
General disorders
Chills
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Creatinine
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Creatinine increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Nervous system disorders
Depressed level of consciousness
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
45.5%
5/11 • Number of events 5 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Febrile neutropenia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
General disorders
Fever
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Renal and urinary disorders
Hemoglobin
|
45.5%
5/11 • Number of events 5 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Vascular disorders
Hypertension
|
18.2%
2/11 • Number of events 6 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
18.2%
2/11 • Number of events 5 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
18.2%
2/11 • Number of events 4 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Vascular disorders
Hypotension
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
36.4%
4/11 • Number of events 5 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
INR increased
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Infections and infestations
Infection
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Leukocytes (total WBC)
|
27.3%
3/11 • Number of events 3 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Lymphocyte count decreased
|
36.4%
4/11 • Number of events 22 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Lymphopenia
|
63.6%
7/11 • Number of events 7 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Gastrointestinal disorders
Nausea
|
27.3%
3/11 • Number of events 6 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Neutrophil count decreased
|
36.4%
4/11 • Number of events 10 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
63.6%
7/11 • Number of events 7 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Platelet count decreased
|
36.4%
4/11 • Number of events 12 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Platelets
|
63.6%
7/11 • Number of events 7 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Nervous system disorders
Restlessness
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Infections and infestations
Urinary tract infection
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Renal and urinary disorders
Urine output decreased
|
18.2%
2/11 • Number of events 2 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 3 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
Weight loss
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
9.1%
1/11 • Number of events 1 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
|
Investigations
White blood cell decreased
|
36.4%
4/11 • Number of events 10 • Date treatment consent signed to approximately 6 weeks following cell administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place