NCT05451849 · OUTCOME
Disease Control Rate (DCR)
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 first TC-510 infusion through study completion (up to approximately 38 months)
What was measured
DCR is defined as the ORR plus the proportion of patients with Stable Disease (SD) for at least 8 weeks via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
Analysis population: The modified ITT Population included all participants enrolled and treated with TC-510.
Groups in this outcome
Phase 1
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
| Group | Source count |
|---|---|
| Phase 1 | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- DCR is defined as the ORR plus the proportion of patients with Stable Disease (SD) for at least 8 weeks via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
- groups
- description
- Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
- id
- OG000
- title
- Phase 1
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The modified ITT Population included all participants enrolled and treated with TC-510.
- reporting Status
- POSTED
- time Frame
- From first TC-510 infusion through study completion (up to approximately 38 months)
- title
- Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle