TriangleNCT05194735 · OUTCOME
Percent Change in TCR-T Cell Count From Post Dose to Day 28
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- percent change from peak post dose
- Interval / dispersion
- Full Range
- Time frame
- Post-dose through Day 28
What was measured
Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
Analysis population: 8 participants received TCR-T infusion and were included in the analysis (1 assigned at Dose Level 1, 7 assigned at Dose Level 2).
Groups in this outcome
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
| Group | Source count |
|---|---|
| Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) | 1 |
| Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) | 7 |
| Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) | -90.5 | Not reported | Not reported | Not reported | Not reported |
| Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) | -96.7 | Not reported | -100 | -91.1 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- -90.5
- group Id
- OG001
- lower Limit
- -100
- upper Limit
- -91.1
- value
- -96.7
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Assessed by comparing each participant's highest post-dose TCR-T cell count (copies per 1×10⁶ cells by qPCR) to the TCR-T cell count at Day 28. Percent change was calculated as: ((Day 28 - peak post-dose) / peak post-dose) × 100.
- dispersion Type
- Full Range
- groups
- description
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
- id
- OG000
- title
- Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
- description
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
- id
- OG001
- title
- Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
- description
- Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
- id
- OG002
- title
- Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)
- param Type
- MEDIAN
- population Description
- 8 participants received TCR-T infusion and were included in the analysis (1 assigned at Dose Level 1, 7 assigned at Dose Level 2).
- reporting Status
- POSTED
- time Frame
- Post-dose through Day 28
- title
- Percent Change in TCR-T Cell Count From Post Dose to Day 28
- type
- SECONDARY
- unit Of Measure
- percent change from peak post dose
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice