TriangleNCT05451849 · STUDY IN CONTEXT
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
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
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
ORR is the proportion of patients with a Complete Response (CR) or Partial Response (PR) via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
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.
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-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- trial label
- A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
- 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
- 3
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0000
- source section id
- NCT05451849-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
- endpoint definition
- TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
- time origin
- From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The modified ITT Population included all participants enrolled and treated with TC-510.
- 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-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0001
- source section id
- NCT05451849-om-0001
- source outcome index
- 1
- endpoint
- Overall Response Rate (ORR)
- endpoint definition
- ORR is the proportion of patients with a Complete Response (CR) or Partial Response (PR) via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
- time origin
- From first TC-510 infusion through study completion (up to approximately 38 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The modified ITT Population included all participants enrolled and treated with TC-510.
- 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-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0002
- source section id
- NCT05451849-om-0002
- source outcome index
- 2
- endpoint
- Disease Control Rate (DCR)
- endpoint definition
- 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.
- time origin
- From first TC-510 infusion through study completion (up to approximately 38 months)
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- The modified ITT Population included all participants enrolled and treated with TC-510.
- 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-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Phase 1
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05451849-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Phase 1
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05451849-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Phase 1
- regimen
- 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.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT05451849-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-bile-duct-cancer-cholangiocarcinoma
- nct id
- NCT05451849
- harm key
- EG000
- source section id
- NCT05451849-ae
- event group key
- EG000
- event group label
- Phase 1
- serious affected
- 4
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
- event definition
- The modified ITT Population included all participants enrolled and treated with TC-510.
- 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