Trial Outcomes & Findings for CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer (NCT NCT01583686)
NCT ID: NCT01583686
Last Updated: 2019-10-14
Results Overview
Objective tumor regression response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
3.5 mos.
Results posted on
2019-10-14
Participant Flow
All reporting groups are in the Phase I portion of the study because the study was terminated before reaching phase II.
Participant milestones
| Measure |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CAR T Cell Receptor Immunotherapy Targeting Mesothelin for Patients With Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 5.57 • n=5 Participants
|
56.03 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 1.31 • n=5 Participants
|
51.77 years
STANDARD_DEVIATION 6.38 • n=4 Participants
|
47.97 years
STANDARD_DEVIATION 16.1 • n=21 Participants
|
54.1 years
STANDARD_DEVIATION 6.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
3 participants
n=21 Participants
|
15 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 3.5 mos.Objective tumor regression response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST)v1.0. Complete Response (CR) is disappearance of all target lesions. Partial Response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease taking as reference the smallest sum LD. Progressive Disease (PD) is at least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
|---|---|---|---|---|---|
|
Number of Patients With Objective Tumor Regression
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Regression
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Regression
Stable Disease
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Patients With Objective Tumor Regression
Progressive Disease
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in 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 |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
n=3 Participants
1/Phase I:
Drug: Fludarabine Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
Adverse Events
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
Other adverse events
| Measure |
Arm A01 Anti-mesothelin CAR PBL 1x10^6 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A02 Anti-mesothelin CAR PBL 3x10^6 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A03 Anti-mesothelin CAR PBL 1x10^7 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A04 Anti-mesothelin CAR PBL 3x10^7 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
Arm A05 Anti-mesothelin CAR PBL 1x10^8 + IL-2
n=3 participants at risk
1/Phase I:
Drug: Fludarabine
Days -5 to Day -1: Fludarabine 25 mg/m\^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Names: •Fludara
Biological/Vaccine: Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)
Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
Drug: Cyclophosphamide
Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
Other Names: •Cytoxan
Drug: Aldesleukin
Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
Other Names: •Proleukin
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia: Sinus tachycardia
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Lymphopenia
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Gastrointestinal disorders
Pain: Abdomen NOS
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Infections and infestations
Infection with unknown ANC: Nerve-peripheral
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
White blood cell count decreased
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Metabolism and nutrition disorders
Albumin (hypoalbuminemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Psychiatric disorders
Psychosis
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) count decreased
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Platelets
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Vascular disorders
Thrombosis/embolism (vascular access related)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
Magnesium, serum-high (hypermagnesemia)
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
General disorders
TRALI
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately 6 months and 17 days for Group A01, 16 months and 13 days for Group A02, 13 months and 3 days for Group A03, 10 months and 16 days for Group A04, and 11 months and 26 days for Group A05.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place