TriangleNCT03937791 · STUDY IN CONTEXT
Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
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
Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.
The fraction of patients who experience a complete response. Complete Response is disappearance of all target lesions. No appearance of new lesions.
Grade 2 adverse event is moderate.
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-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- trial label
- Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
- 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-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0002
- source section id
- NCT03937791-om-0002
- source outcome index
- 2
- endpoint
- Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- endpoint definition
- Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence.
- time origin
- Date treatment consent signed to date off study, approximately 8 months and 6 days.
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0000
- source section id
- NCT03937791-om-0000
- source outcome index
- 0
- endpoint
- Fraction of Participants With Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) Who Experience a Complete Response for E7 T-Cell Receptor (TCR) T Cells Treatment
- endpoint definition
- The fraction of patients who experience a complete response. Complete Response is disappearance of all target lesions. No appearance of new lesions.
- time origin
- 3 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0001
- source section id
- NCT03937791-om-0001
- source outcome index
- 1
- endpoint
- Number of Grade 2 Adverse Events Unlikely Related to Drug in Participants Who Received E7 T-Cell Receptor (TCR) T Cells Administered in a Low Intensity Setting Without Conditioning or Systemic Aldesleukin
- endpoint definition
- Grade 2 adverse event is moderate.
- time origin
- 30 days following the last dose of study therapy
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- 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-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
- regimen
- 1x10\^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0. E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03937791-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
- regimen
- 1x10\^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0. E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03937791-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
- regimen
- 1x10\^11 E7 TCR T cells will be administered intravenously over 20 to 30 minutes on day 0. E7 T Cell Receptor (TCR): One dose of E7 TCR T cells (1x10\^11 cells) will be administered intravenously over 20 to 30 minutes.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03937791-om-0002#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-high-grade-vulvar-squamous-intraepithelial-lesion
- nct id
- NCT03937791
- harm key
- EG000
- source section id
- NCT03937791-ae
- event group key
- EG000
- event group label
- Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 8 months and 6 days.
- event definition
- Source null
- 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