TriangleNCT03054298 · STUDY IN CONTEXT
CAR T Cells in Mesothelin Expressing Cancers
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
Overall Survival
Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included. Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- trial label
- CAR T Cells in Mesothelin Expressing Cancers
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 7
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- source section id
- NCT03054298-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
- endpoint definition
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
- time origin
- 7 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cohort 4 closed prematurely.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- source section id
- NCT03054298-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- Progression is defined using RECIST V1.1 - at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Note: the appearance of one or more new lesions is also considered progression.
- time origin
- 7 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cohort 4 was permanently closed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0002
- source section id
- NCT03054298-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival
- endpoint definition
- Overall Survival
- time origin
- 7 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cohort 4 was prematurely closed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0003
- source section id
- NCT03054298-om-0003
- source outcome index
- 3
- endpoint
- Objective Response Rate
- endpoint definition
- Objective response rate is the proportion of subjects in the efficacy-evaluable set with radiologically confirmed measurable disease at baseline, who achieved partial response (PR) or better after infusion as determined by RECIST 1.1. Missing or non-evaluable time points will not be included. Per RECIST 1.1, a complete response is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm." A partial response is defined as "at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters."
- time origin
- Month 6
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Cohort 4 was permanently closed.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Cohort 1
- regimen
- Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Cohort 2
- regimen
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Cohort 3
- regimen
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG003
- arm label
- Cohort 4
- regimen
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG004
- arm label
- Cohort 5
- regimen
- Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG004
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG005
- arm label
- Cohort 6
- regimen
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to dose of 1-3x10\^7 huCART-meso cells/m\^2 via IV infusion on Day 0. This initial infusion may be followed by up to two additional IV infusions of huCART-meso cells at the same dose level, given approximately 21-42 days apart, if the subject meets eligibility to receive additional infusions. Cyclophosphamide will not be repeated prior to subsequent doses of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG005
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0000
- arm key
- OG006
- arm label
- Cohort 7
- regimen
- Cyclophosphamide 300 mg/m\^2/day and fludarabine 30 mg/m\^2/day given over 3 days by IV infusion followed by a single dose of 1-3x10\^7 huCART-meso cells/m\^2 via intraperitoneal (i.p.) administration. Lymphodepleting chemotherapy will be scheduled such that the last day of chemotherapy is 3 days (+/- 1 day) prior to the infusion of huCART-meso cells. This initial i.p. infusion may be followed by up to two additional infusions of huCART-meso cells via intravenous (IV) administration at the same dose level, given between 21-42 days apart. The subject must meet eligibility to receive additional infusions. Lymphodepleting chemotherapy will not be repeated prior to additional infusions of huCART-meso cells. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0000#groups/OG006
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Cohort 1
- regimen
- Single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Cohort 2
- regimen
- Cyclophosphamide 1 gram/m\^2 administered 2-4 days prior to a single dose of 1-3x10\^7 huCARTmeso cells/m\^2 huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 3
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- arm key
- OG002
- arm label
- Cohort 3
- regimen
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- arm key
- OG003
- arm label
- Cohort 4
- regimen
- PERMANENTLY CLOSED huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0001#groups/OG003
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- outcome key
- om-0001
- arm key
- OG004
- arm label
- Cohort 5
- regimen
- Single dose of 1-3x10\^7 huCART-meso cells/m\^2 day 0 by intrapleural infusion (IP) through an indwelling pleural catheter without any conditioning chemotherapeutic regimen. huCART-meso cells: Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03054298-om-0001#groups/OG004
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG000
- source section id
- NCT03054298-ae
- event group key
- EG000
- event group label
- Cohort 1
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG001
- source section id
- NCT03054298-ae
- event group key
- EG001
- event group label
- Cohort 2
- serious affected
- 1
- serious at risk
- 3
- other affected
- 3
- other at risk
- 3
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG002
- source section id
- NCT03054298-ae
- event group key
- EG002
- event group label
- Cohort 3
- serious affected
- 2
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG003
- source section id
- NCT03054298-ae
- event group key
- EG003
- event group label
- Cohort 4
- serious affected
- 0
- serious at risk
- 0
- other affected
- 0
- other at risk
- 0
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG004
- source section id
- NCT03054298-ae
- event group key
- EG004
- event group label
- Cohort 5
- serious affected
- 1
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG005
- source section id
- NCT03054298-ae
- event group key
- EG005
- event group label
- Cohort 6
- serious affected
- 4
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-peritoneal-neoplasm
- nct id
- NCT03054298
- harm key
- EG006
- source section id
- NCT03054298-ae
- event group key
- EG006
- event group label
- Cohort 7
- serious affected
- 6
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- 7 years
- event definition
- Cohort 4 was closed without any subjects being enrolled. Subjects were transitioned to a separate long-term follow-up (LTFU) protocol for a variety of reasons (e.g. disease progression, receipt of alternative therapy, PI discretion, etc). Only protocol-defined adverse events (PDAEs) were collected/reported on the separate LTFU protocol, and death due to disease progression was not considered a PDAE. PDAEs are defined in the protocol section 8.1.1.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice