Trial Outcomes & Findings for Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies (NCT NCT03056339)
NCT ID: NCT03056339
Last Updated: 2024-03-25
Results Overview
Toxicity is defined as a grade 3 or 4 within 40 days of NK cell infusion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
49 participants
Primary outcome timeframe
40 days
Results posted on
2024-03-25
Participant Flow
Recruitment period: June 2017 to May 2021. All participants were registered at The University of Texas MD Anderson Cancer Center.
Patient accession #3 and #21 are the same patient. The patient was taken off protocol and re-consented for a second infusion. Patient was only evaluated in regards to safety and efficacy as 1 subject.
Participant milestones
| Measure |
Group 1: 1x105 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
23
|
17
|
|
Overall Study
COMPLETED
|
3
|
4
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
7
|
1
|
Reasons for withdrawal
| Measure |
Group 1: 1x105 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Overall Study
Failed Requirements
|
0
|
2
|
7
|
1
|
Baseline Characteristics
Umbilical & Cord Blood (CB) Derived CAR-Engineered NK Cells for B Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Total
n=49 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
31 Participants
n=21 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
23 participants
n=5 Participants
|
17 participants
n=4 Participants
|
49 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 40 daysToxicity is defined as a grade 3 or 4 within 40 days of NK cell infusion.
Outcome measures
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Number of Events That Was Grade 3-4 Toxicities
Grade 3 - Toxicities
|
4 events
|
1 events
|
22 events
|
1 events
|
|
Number of Events That Was Grade 3-4 Toxicities
Grade 4 - Toxicities
|
0 events
|
0 events
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: 30 daysParticipants response was defined as partial or complete response by Efftox assessment below. * Acute lymphoblastic leukemia: Complete response will be defined as bone marrow with \< 5% blasts, the absence of circulating blasts, and no extramedullary sites of disease (as assessed by means of computed tomography or positron-emission tomography), regardless of cell-count recovery. * CLL: Response will be defined based on the NCI-WG/IWCLL 2008 criteria, Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia. Lymphomas: Response will be defined based on the Lugano criteria- Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma:
Outcome measures
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Overall Response Rate of Participants Analyzed
Complete Response
|
2 participants
|
3 participants
|
3 participants
|
5 participants
|
|
Overall Response Rate of Participants Analyzed
Partial Response
|
0 participants
|
0 participants
|
5 participants
|
3 participants
|
|
Overall Response Rate of Participants Analyzed
Progressive Disease
|
1 participants
|
1 participants
|
6 participants
|
2 participants
|
|
Overall Response Rate of Participants Analyzed
Not Evaluable
|
0 participants
|
2 participants
|
7 participants
|
2 participants
|
|
Overall Response Rate of Participants Analyzed
Stable Disease
|
0 participants
|
0 participants
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Up to 100 days after NK cell infusionNumber of participants that had Complete and Partial Response.
Outcome measures
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 Participants
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Number of Participants Achieved an Objective Response
Complete Response
|
2 participants
|
3 participants
|
4 participants
|
5 participants
|
|
Number of Participants Achieved an Objective Response
Partial Response
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
Adverse Events
Group 1: 1x105 NK Cells /kg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: 1x106 NK Cells /kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Group 3: 1x107 NK Cells /kg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 4: 8x108 Flat NK Cell Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
General disorders
General disorders and administration site conditions
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
Other adverse events
| Measure |
Group 1: 1x105 NK Cells /kg
n=3 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 10E5
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 2: 1x106 NK Cells /kg
n=6 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 106
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 3: 1x107 NK Cells /kg
n=23 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 107
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
Group 4: 8x108 Flat NK Cell Dose
n=17 participants at risk
On Days -5, -4, and -3, participants receive Fludarabine and Cyclophosphamide. Participants also receive Mesna before and after the cyclophosphamide dose.
On Day 0, participants receive genetically modified NK cells as a cell infusion.
If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they receive AP1903 by vein and possibly steroids by mouth or by vein.
Fludarabine: 30 mg/m2 by vein on Days -5 to -3.
Cyclophosphamide: 300 mg/m2 by vein on Days -5 to -3.
Mesna: 300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
iC9/CAR.19/IL15-Transduced CB-NK Cells: Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
Starting dose: 108
AP1903: If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Reproductive system and breast disorders
Prostatic pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
43.5%
10/23 • Number of events 10 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Stroke
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Vascular disorders
Vascular disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Vomiting
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Weight gain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
General disorders
Fever
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
34.8%
8/23 • Number of events 8 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
General disorders
Gastrointestinal disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Nervous system disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
General disorders
Pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
General disorders
General disorders and administration site conditions
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Pleural effusion
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Vascular disorders
Hematoma
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
23.5%
4/17 • Number of events 5 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Immune system disorders
Immune system disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Infections and infestations
Infections and infestations
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
50.0%
3/6 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
21.7%
5/23 • Number of events 5 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Investigations - (Other)
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
100.0%
6/6 • Number of events 8 • Adverse events were collected from the time of infusion up to 40 days.
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - (Other)
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
52.2%
12/23 • Number of events 12 • Adverse events were collected from the time of infusion up to 40 days.
|
41.2%
7/17 • Number of events 7 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Abdominal Pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Immune system disorders
Allergic reaction
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Musculoskeletal and connective tissue disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
13.0%
3/23 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Immune system disorders
Arthralgia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
17.6%
3/17 • Number of events 3 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Injury, poisoning and procedural complications
Back pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - (Other)
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Blood and lymphatic system disorders
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Cardiac disorders - (Other), specify
|
33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
17.4%
4/23 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Chest pain
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
General disorders
Chills
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
21.7%
5/23 • Number of events 5 • Adverse events were collected from the time of infusion up to 40 days.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
23.5%
4/17 • Number of events 4 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
8.7%
2/23 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
35.3%
6/17 • Number of events 6 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Dizziness
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/23 • Adverse events were collected from the time of infusion up to 40 days.
|
5.9%
1/17 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Immune system disorders
Dyspnea
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
11.8%
2/17 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Hepatobiliary disorders
Encephalopathy
|
0.00%
0/3 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
4.3%
1/23 • Number of events 1 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/17 • Adverse events were collected from the time of infusion up to 40 days.
|
|
Cardiac disorders
Fatigue
|
66.7%
2/3 • Number of events 2 • Adverse events were collected from the time of infusion up to 40 days.
|
0.00%
0/6 • Adverse events were collected from the time of infusion up to 40 days.
|
43.5%
10/23 • Number of events 10 • Adverse events were collected from the time of infusion up to 40 days.
|
58.8%
10/17 • Number of events 10 • Adverse events were collected from the time of infusion up to 40 days.
|
Additional Information
Dr. Loretta Nastoupil, M.D. / Stem Cell Transplantation and Cellular Therapy Department
The University of Texas MD Anderson Cancer Center
Phone: 713-792-2860
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place