TriangleNCT05194735 · OUTCOME
Frequency of Dose Limiting Toxicities
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From Day 0 to Day 28 post TCR-T cell drug product infusion.
What was measured
Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
Analysis population: Participants who received the planned TCR-T cell infusion and either experienced a DLT or completed the 28-day DLT observation period; those with major protocol deviations unrelated to safety during this period were considered non-evaluable.
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) | 0 | Not reported | Not reported | Not reported | Not reported |
| Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- Number of participants experiencing DLTs, defined as specific adverse events attributable to the TCR-T cell drug product occurring within the first 28 days of infusion. DLTs include, but are not limited to, Grade 4 neutropenia lasting ≥ 14 days, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with significant bleeding, and ≥ Grade 3 febrile neutropenia with hemodynamic compromise. Non-hematologic DLTs include Grade 3 or 4 Cytokine Release Syndrome (CRS) that does not improve to Grade ≤ 2 within 72 hours, and Grade 3 Immune-effector cell-associated neurotoxicity syndrome (ICANS) that does not resolve to Grade ≤ 2 within 7 days, among others. The severity of adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
- 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
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received the planned TCR-T cell infusion and either experienced a DLT or completed the 28-day DLT observation period; those with major protocol deviations unrelated to safety during this period were considered non-evaluable.
- reporting Status
- POSTED
- time Frame
- From Day 0 to Day 28 post TCR-T cell drug product infusion.
- title
- Frequency of Dose Limiting Toxicities
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice