TriangleNCT05032820 · OUTCOME
Exploratory Objective 2: Peak CAR T-cell Expansion
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- copies/mcg DNA
- Interval / dispersion
- Standard Deviation
- Time frame
- 6 months
What was measured
Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Peak CAR T-cell expansion will be compared between subjects who are and are not in CR at 6 months.
Analysis population: Participants who received an infusion
Groups in this outcome
Lenalidomide and bb2121
Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
| Group | Source count |
|---|---|
| Lenalidomide and bb2121 | 38 |
Reported measurements
In CR/sCR at 6 mth
| Group | Source count |
|---|---|
| Lenalidomide and bb2121 | 24 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and bb2121 | 110502.71 | 102932.728 | Not reported | Not reported | Not reported |
Not in CR/sCR at 6 mth
| Group | Source count |
|---|---|
| Lenalidomide and bb2121 | 14 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Lenalidomide and bb2121 | 101723.96 | 272376.464 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 102932.728
- value
- 110502.71
- denoms
- counts
- group Id
- OG000
- value
- 24
- units
- Participants
- title
- In CR/sCR at 6 mth
- categories
- measurements
- group Id
- OG000
- spread
- 272376.464
- value
- 101723.96
- denoms
- counts
- group Id
- OG000
- value
- 14
- units
- Participants
- title
- Not in CR/sCR at 6 mth
- denoms
- counts
- group Id
- OG000
- value
- 38
- units
- Participants
- description
- Quantitation of CAR T-cells in peripheral blood will be determined at specified timepoints by quantitative PCR assay, measured in copies/mcg genomic DNA. Peak CAR T-cell expansion will be compared between subjects who are and are not in CR at 6 months.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients complete apheresis and proceed to lymphodepleting chemotherapy with cyclophosphamide 300mg/m\^2 and fludarabine 30mg/m\^2 for 3 consecutive days followed by the infusion of BCMA CAR T-cells at a target dose of 450 x10\^6 cells. Maintenance lenalidomide, starting at 5mg a day for 21 days of a 28-day cycle will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the patient reaches 12 months post CAR T-cell infusion and continue free of progression. Lenalidomide: Maintenance lenalidomide, starting at 5 mg a day for 21 days of a 28-day cycle, will be initiated at a minimum of at least 30 days, but no later than 180 days after the CAR T-cell infusion and will continue until the participant reaches 12 months post CAR T-cell infusion and continues free of progression bb2121: Participants receive infusion of BCMA CAR T-cells at a target dose of 450 x 10\^6 cells. Cyclophosphamide: 300 mg/m\^2/day for 3 consecutive days prior to the CAR T infusion Fludarabine: 30 mg/m\^2/day or 3 consecutive days prior to the CAR T infusion leukapheresis: Placement of central line catheter and leukapheresis
- id
- OG000
- title
- Lenalidomide and bb2121
- param Type
- MEDIAN
- population Description
- Participants who received an infusion
- reporting Status
- POSTED
- time Frame
- 6 months
- title
- Exploratory Objective 2: Peak CAR T-cell Expansion
- type
- OTHER_PRE_SPECIFIED
- unit Of Measure
- copies/mcg DNA
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice