TriangleNCT02280811 · OUTCOME
Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- % PD-1 circulating lymphocytes
- Interval / dispersion
- Full Range
- Time frame
- one month after treatment
What was measured
Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.
Analysis population: One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
Groups in this outcome
HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
HPV-16 E6 mTCR PBL MTD + HD IL-2
patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
| Group | Source count |
|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 1 |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 6 |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2 | 1 | Not reported | 1 | 1 | Not reported |
| HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2 | 2 | Not reported | 2 | 2 | Not reported |
| HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2 | 3 | Not reported | 3 | 3 | Not reported |
| HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2 | 1 | Not reported | 0 | 3.6 | Not reported |
| HPV-16 E6 mTCR PBL MTD + HD IL-2 | 2.2 | Not reported | 0.5 | 3.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 1
- value
- 1
- group Id
- OG001
- lower Limit
- 2
- upper Limit
- 2
- value
- 2
- group Id
- OG002
- lower Limit
- 3
- upper Limit
- 3
- value
- 3
- group Id
- OG003
- lower Limit
- 0
- upper Limit
- 3.6
- value
- 1
- group Id
- OG004
- lower Limit
- 0.5
- upper Limit
- 3.9
- value
- 2.2
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Presence of PD-1 on circulating lymphocytes by flow cytometry one month after treatment.
- dispersion Type
- Full Range
- groups
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG000
- title
- HPV-16 E6 mTCR PBL 1x10^9 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG001
- title
- HPV-16 E6 mTCR PBL 1x10^10 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG002
- title
- HPV-16 E6 mTCR PBL 1x10^11 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG003
- title
- HPV-16 E6 mTCR PBL >1x10^11 up to 2x10^11 + HD IL-2
- description
- patients will receive cyclophosphamide and fludarabine followed by infusion of the human papilloma virus (HPV) E6 T cell receptor (TCR), followed by high dose aldesleukin Fludarabine: Patients will receive Fludarabine 25 mg/m\^2/day for 5 days. Cyclophosphamide: Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days E6 TCR: On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine) Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
- id
- OG004
- title
- HPV-16 E6 mTCR PBL MTD + HD IL-2
- param Type
- MEAN
- population Description
- One patient in group HPV-16 E6 mTCR PBL 1x10\^10 + HD IL-2 did not have research blood collected at one month post infusion, and thus could not examine the cells for that patient at that time point.
- reporting Status
- POSTED
- time Frame
- one month after treatment
- title
- Expression of Programmed Cell Death 1 (PD-1) by Circulating E6 T-Cell Receptor (TCR) T-Cells
- type
- SECONDARY
- unit Of Measure
- % PD-1 circulating lymphocytes
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice