TriangleNCT03430011 · OUTCOME
Overall Response Rate (ORR) in Phase 1 and Phase 1 Anakinra
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percent of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to 61 approximately months)
What was measured
ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders. sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg/24 h
Analysis population: All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 1 and in phase 1 Anakinra
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
| 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 | 20 |
| Phase 1 600 x 10^6 Cells | 20 |
| Phase 1 Anakinra 600 x 10^6 Cells | 14 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 50 x 10^6 Cells | 78.6 | Not reported | 49.2 | 95.3 | Not reported |
| Phase 1 150 x 10^6 Cells | 86.7 | Not reported | 69.3 | 96.2 | Not reported |
| Phase 1 300 x 10^6 Cells | 96.2 | Not reported | 80.4 | 99.9 | Not reported |
| Phase 1 450 x 10^6 Cells | 90.0 | Not reported | 68.3 | 98.8 | Not reported |
| Phase 1 600 x 10^6 Cells | 100.0 | Not reported | 83.2 | 100.0 | Not reported |
| Phase 1 Anakinra 600 x 10^6 Cells | 100.0 | Not reported | 76.8 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 49.2
- upper Limit
- 95.3
- value
- 78.6
- group Id
- OG001
- lower Limit
- 69.3
- upper Limit
- 96.2
- value
- 86.7
- group Id
- OG002
- lower Limit
- 80.4
- upper Limit
- 99.9
- value
- 96.2
- group Id
- OG003
- lower Limit
- 68.3
- upper Limit
- 98.8
- value
- 90.0
- group Id
- OG004
- lower Limit
- 83.2
- upper Limit
- 100.0
- value
- 100.0
- group Id
- OG005
- lower Limit
- 76.8
- upper Limit
- 100.0
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 26
- group Id
- OG003
- value
- 20
- group Id
- OG004
- value
- 20
- group Id
- OG005
- value
- 14
- units
- Participants
- description
- ORR is defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR), according to IMWG criteria. Participants without any reported disease response assessments will be considered non-responders. sCR=complete response plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry; CR=negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. When the only method to measure disease is by serum FLC levels, CR can be defined as a normal FLC ratio of 0.26 to 1.65; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein level plus urine M-protein level \< 100 mg/24 h; PR=≥ 50% reduction of serum M protein plus reduction in 24-hour urinary M-protein by ≥ 90% or to \< 200 mg/24 h
- dispersion Type
- 95% Confidence Interval
- 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
- param Type
- NUMBER
- population Description
- All participants who received conforming JCARH125 cell product at the recommended phase 2 dose (and at least one dose of anakinra as prophylactic intervention for phase 1 Anakinra) and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 1 and in phase 1 Anakinra
- reporting Status
- POSTED
- time Frame
- From the time of the JCARH125 infusion until disease progression, end of study, or the start of another anticancer therapy or stem cell transplant (Up to 61 approximately months)
- title
- Overall Response Rate (ORR) in Phase 1 and Phase 1 Anakinra
- type
- SECONDARY
- unit Of Measure
- Percent of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice