Trial Outcomes & Findings for CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer (NCT NCT01218867)
NCT ID: NCT01218867
Last Updated: 2019-12-10
Results Overview
Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
TERMINATED
PHASE1/PHASE2
24 participants
5 years
2019-12-10
Participant Flow
Twenty-four participants were enrolled but one participant was not treated due to a new cancer diagnosis which made the participant ineligible for this protocol.
Participant milestones
| Measure |
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
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Overall Study
STARTED
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1
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1
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3
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1
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1
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1
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4
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3
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3
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4
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2
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Overall Study
COMPLETED
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1
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1
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3
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1
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1
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1
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3
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3
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3
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4
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2
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Overall Study
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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1
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death during treatment
|
0
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0
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0
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0
|
0
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0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
CAR T Cell Receptor Immunotherapy Targeting VEGFR2 for Patients With Metastatic Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Total
n=24 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
23 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 0 • n=5 Participants
|
51.0 years
STANDARD_DEVIATION 0 • n=7 Participants
|
52.7 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 0 • n=4 Participants
|
55.0 years
STANDARD_DEVIATION 0 • n=21 Participants
|
35.0 years
STANDARD_DEVIATION 0 • n=10 Participants
|
45.5 years
STANDARD_DEVIATION 11.3 • n=115 Participants
|
37.0 years
STANDARD_DEVIATION 18.0 • n=6 Participants
|
54.7 years
STANDARD_DEVIATION 11.9 • n=6 Participants
|
46.3 years
STANDARD_DEVIATION 5.6 • n=64 Participants
|
41.5 years
STANDARD_DEVIATION 10.6 • n=17 Participants
|
47.9 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
17 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
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
22 Participants
n=21 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
20 Participants
n=21 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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
4 Participants
n=21 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=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
4 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
24 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 5 yearsResponse was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). 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. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment starts or the appearance of one or more new lesions. Stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD.
Outcome measures
| Measure |
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Response to Therapy
Complete Response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Partial Response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Stable Disease (SD)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Response to Therapy
Progressive Disease (PD)
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, approximately, 33 months and 25 daysHere is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v3.0). 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 |
Cohort 1 - 1x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 - 3x10(6) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 - 1x10(7) Cells (High Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 - 3x10(7) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 - 1x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 - 3x10(8) Cells (High Dose IL-2)
n=1 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 - 1x10(9) Cells (High Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 - 1x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 - 3x10(9) Cells (Low Dose IL-2)
n=3 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 - 1x10(10) Cells (Low Dose IL-2)
n=4 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 - 3x10(10) Cells (Low Dose IL-2)
n=2 Participants
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious and Non-Serious Adverse Events
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 yearsPopulation: This outcome measure was not done due to the lack of a minimum number (e.g. 4) of required durable responses in the participants. A durable response is defined as a complete response, partial response, or stable disease in at least 4 participants.
Immunological monitoring using both tetramer analysis and staining for the T cell receptor (TCR) will be used to augment polymerase chain reaction (PCR)-based analysis. This will provide data to estimate the in vivo survival of lymphocytes derived from the infused cells.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (1x10(6) Cells (High Dose IL-2)
Cohort 2 (3x10(6) Cells (High Dose IL-2)
Cohort 3 (1x10(7) Cells (High Dose IL-2)
Cohort 4 (3x10(7) Cells (High Dose IL-2)
Cohort 5 (1x10(8) Cells (High Dose IL-2)
Cohort 6 (1x10(8) Cells (High Dose IL-2)
Cohort 7 (1x10(9) Cells (High Dose IL-2)
Cohort 8 (1x10(9) Cells (Low Dose IL-2)
Cohort 9 (3x10(9) Cells (Low Dose IL-2)
Cohort 10 (1x10(10) Cells (Low Dose IL-2)
Cohort 11 (3x10(10) Cells (Low Dose IL-2)
Serious adverse events
| Measure |
Cohort 1 (1x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 (3x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 (1x10(7) Cells (High Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 (3x10(7) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 (1x10(9) Cells (High Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 (1x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 (3x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 (1x10(10) Cells (Low Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 (3x10(10) Cells (Low Dose IL-2)
n=2 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
General disorders
Pain
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Infections and infestations
Infection
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
Other adverse events
| Measure |
Cohort 1 (1x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 2 (3x10(6) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 3 (1x10(7) Cells (High Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 4 (3x10(7) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 5 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 6 (1x10(8) Cells (High Dose IL-2)
n=1 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 7 (1x10(9) Cells (High Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 8 (1x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 9 (3x10(9) Cells (Low Dose IL-2)
n=3 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 10 (1x10(10) Cells (Low Dose IL-2)
n=4 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
Cohort 11 (3x10(10) Cells (Low Dose IL-2)
n=2 participants at risk
Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr
Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Creatinine
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
Hemoglobin
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
Leukocytes (Total WBC)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
Lymphopenia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
2/2 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
Platelets
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
4/4 • Number of events 4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Infections and infestations
Infection
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplstin Time)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Cardiac disorders
Hypotension
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Infections and infestations
Febrile neutropenia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
75.0%
3/4 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
3/3 • Number of events 3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Nervous system disorders
Confusion
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Nervous system disorders
Psychosis (hallucinations/delusions)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Ear and labyrinth disorders
Hearing: patients with/without baseline audiogram and enrolled in a monitoring program
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Renal and urinary disorders
Hemorrhage, GU
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
AST, SGOT (serum glutamic oxaloacetic transaminase)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Eye disorders
Ocular/Visual-Other (vision changes)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
General disorders
Pain
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
General disorders
Syndromes - Other (hemaphogocytic syndrome)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Vascular disorders
Acute vascular leak syndrome
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
66.7%
2/3 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
50.0%
2/4 • Number of events 2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Nervous system disorders
Syncope (fainting)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
33.3%
1/3 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
|
Renal and urinary disorders
Renal/Genitourinary - Other (low urine output)
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/4 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/3 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
25.0%
1/4 • Number of events 1 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
0.00%
0/2 • Date treatment consent signed to date off study, approximately, 33 months and 25 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place