TriangleNCT02650986 · OUTCOME
Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
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
- 1 month
What was measured
Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
Groups in this outcome
Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis
| Group | Source count |
|---|---|
| Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | 3 |
| Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | 3 |
| Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 3 |
| Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2) | 1 | Not reported | Not reported | Not reported | Not reported |
| Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 | Not reported | Not reported | Not reported | Not reported |
| Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- Unfeasibility will be defined as 3 or more preparations not meeting the lot release criteria in each cohort. Sufficient numbers of circulating, lot released confirmed T cells will be measured prior to administration. The count of patients not meeting the preparation criteria are reported.
- groups
- description
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^7 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- id
- OG000
- title
- Cohort 1 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 1)
- description
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^8 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- id
- OG001
- title
- Cohort 2 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 2)
- description
- Patients undergo leukapheresis on day -6 and receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes: Given IV
- id
- OG002
- title
- Cohort 3 (Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- description
- Patients undergo leukapheresis on day -6 and receive decitabine IV over 1 hour on days -6 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then receive TGFbDNRII-transduced autologous tumor infiltrating lymphocytes IV over 15 minutes on day 0. Eligible patients who showed initial response/disease control, may receive a second TGFbDNRII-transduced autologous tumor infiltrating lymphocytes infusion at any time after progression is confirmed. Cyclophosphamide: Given IV at 1 x 10\^9 Decitabine: Given IV at 20 mg/m\^2 x 3 days Laboratory Biomarker Analysis: Correlative studies Leukapheresis: Undergo leukapheresis
- id
- OG003
- title
- Cohort 4 (Decitabine, Cyclophosphamide, TCR/dnTGFbetaRII - Dose Level 3)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 1 month
- title
- Number of Participants With Feasibility Concerns in Manufacturing of NY-ESO-1/ dnTGFbetaRII Engineered Cells
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice