TriangleNCT03430011 · OUTCOME
Overall Response Rate (ORR) in Phase 2 and Phase 2a
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 aproximately 61 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 have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
Groups in this outcome
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 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 2 600 x 10^6 Cells | 91.7 | Not reported | 73.0 | 99.0 | Not reported |
| Phase 2a 600 x 10^6 Cells Anti-BCMA | 100.0 | Not reported | 69.2 | 100.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 73.0
- upper Limit
- 99.0
- value
- 91.7
- group Id
- OG001
- lower Limit
- 69.2
- upper Limit
- 100.0
- value
- 100.0
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 10
- 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 600 x 10\^6 consisting of CD3+CAR+T cells expansion
- id
- OG000
- 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
- OG001
- title
- Phase 2a 600 x 10^6 Cells Anti-BCMA
- param Type
- NUMBER
- population Description
- All participants who received conforming JCARH125 cell product at the recommended phase 2 dose and have measurable disease at the last disease assessment prior to receiving JCARH125 infusion in phase 2 and in phase 2a
- 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 aproximately 61 months)
- title
- Overall Response Rate (ORR) in Phase 2 and Phase 2a
- type
- PRIMARY
- unit Of Measure
- Percent of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice