TriangleNCT03430011 · OUTCOME
Time to Maximum Observed Concentration (Tmax)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Day
- Interval / dispersion
- Full Range
- Time frame
- From JCARH125 infusion through the day 29 visit
What was measured
Tmax is the first study day the maximum observed concetration (Cmax) of JCARH125 CAR T cells in the blood is reached as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
Analysis population: All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
Groups in this outcome
Phase 1 50 x 10^6 Cells
JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 150 x 10^6 Cells
JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 300 x 10^6 Cells
JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 450 x 10^6 Cells
JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
Phase 1 Anakinra 600 x 10^6 Cells
2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
Phase 2 600 x 10^6 Cells
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
Phase 2a 600 x 10^6 Cells Anti-BCMA
JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
| Group | Source count |
|---|---|
| Phase 1 50 x 10^6 Cells | 14 |
| Phase 1 150 x 10^6 Cells | 30 |
| Phase 1 300 x 10^6 Cells | 26 |
| Phase 1 450 x 10^6 Cells | 21 |
| Phase 1 600 x 10^6 Cells | 20 |
| Phase 1 Anakinra 600 x 10^6 Cells | 14 |
| Phase 2 600 x 10^6 Cells | 24 |
| Phase 2a 600 x 10^6 Cells Anti-BCMA | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 50 x 10^6 Cells | 13.50 | Not reported | 7.0 | 28.0 | Not reported |
| Phase 1 150 x 10^6 Cells | 11.00 | Not reported | 4.0 | 22.0 | Not reported |
| Phase 1 300 x 10^6 Cells | 10.00 | Not reported | 3.0 | 21.0 | Not reported |
| Phase 1 450 x 10^6 Cells | 10.00 | Not reported | 7.0 | 25.0 | Not reported |
| Phase 1 600 x 10^6 Cells | 10.00 | Not reported | 3.0 | 23.0 | Not reported |
| Phase 1 Anakinra 600 x 10^6 Cells | 13.50 | Not reported | 7.0 | 28.0 | Not reported |
| Phase 2 600 x 10^6 Cells | 9.50 | Not reported | 4.0 | 22.0 | Not reported |
| Phase 2a 600 x 10^6 Cells Anti-BCMA | 14.50 | Not reported | 7.0 | 21.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.0
- upper Limit
- 28.0
- value
- 13.50
- group Id
- OG001
- lower Limit
- 4.0
- upper Limit
- 22.0
- value
- 11.00
- group Id
- OG002
- lower Limit
- 3.0
- upper Limit
- 21.0
- value
- 10.00
- group Id
- OG003
- lower Limit
- 7.0
- upper Limit
- 25.0
- value
- 10.00
- group Id
- OG004
- lower Limit
- 3.0
- upper Limit
- 23.0
- value
- 10.00
- group Id
- OG005
- lower Limit
- 7.0
- upper Limit
- 28.0
- value
- 13.50
- group Id
- OG006
- lower Limit
- 4.0
- upper Limit
- 22.0
- value
- 9.50
- group Id
- OG007
- lower Limit
- 7.0
- upper Limit
- 21.0
- value
- 14.50
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 26
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 14
- group Id
- OG006
- value
- 24
- group Id
- OG007
- value
- 10
- units
- Participants
- description
- Tmax is the first study day the maximum observed concetration (Cmax) of JCARH125 CAR T cells in the blood is reached as determined by quantitative polymerase chain reaction (qPCR) to detect the JCARH125 transgene.
- dispersion Type
- Full Range
- groups
- description
- JCARH125 IV at dose level 50 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG000
- title
- Phase 1 50 x 10^6 Cells
- description
- JCARH125 IV at dose level 150 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG001
- title
- Phase 1 150 x 10^6 Cells
- description
- JCARH125 IV at dose level 300 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG002
- title
- Phase 1 300 x 10^6 Cells
- description
- JCARH125 IV at dose level 450 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG003
- title
- Phase 1 450 x 10^6 Cells
- description
- JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG004
- title
- Phase 1 600 x 10^6 Cells
- description
- 2 doses of 100 mg anakinra administered subcutaneously (SC) for 5 consecutive days + JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells
- id
- OG005
- title
- Phase 1 Anakinra 600 x 10^6 Cells
- description
- JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells expansion
- id
- OG006
- title
- Phase 2 600 x 10^6 Cells
- description
- JCARH125 IV at dose level 600 x 10\^6 consisting of CD3+CAR+T cells in participants previously treated with BCMA-directed anti-myeloma therapy
- id
- OG007
- title
- Phase 2a 600 x 10^6 Cells Anti-BCMA
- param Type
- MEDIAN
- population Description
- All participants who have the necessary PK measurements to provide interpretable results for this specific parameter of interest
- reporting Status
- POSTED
- time Frame
- From JCARH125 infusion through the day 29 visit
- title
- Time to Maximum Observed Concentration (Tmax)
- type
- SECONDARY
- unit Of Measure
- Day
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice