Trial · NCT03197025
Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
NCT03197025, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2019-10-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions. Trials, record NCT03197025. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03197025
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
- NCT number
- NCT03197025
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Human Papillomavirus, HPV-16, High Grade Squamous Intraepithelial Lesion
- Interventions
- Aldesleukin, E6 T Cell Receptor (TCR)
- First posted
- 2017-06-23
- Last updated
- 2021-02-16
- Results first posted
- 2019-10-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of E6 T Cell Receptor (TCR) T Cells for the Treatment of Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | within 30 days of cell infusion | MTD is defined as the highest dose at which a maximum of 1 of 6 participants has a dose limiting toxicity (DLT). A DLT is defined as all treatment related Grade 3 (i.e. severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL)) and greater adverse events occurring within 30 days of the cell infusion with the exception of Grade 3 fever or chills responsive to symptomatic treatment that resolve to ≤ grade 2 in 48 hours. Grade 3 hypotension or oliguria responsive to ≤ 1.5L of intravenous fluid boluses in 24 hours that resolves to ≤ grade 2 in 48 hours. Grade 3 dyspnea/hypoxia that improves to ≤ grade 2 or less with supplemental oxygen and resolves to ≤ grade 2 without supplemental oxygen in 48 hours. Grade 3 creatinine or electrolyte abnormalities that resolve to ≤ grade 2 in 48 hours. |
| Secondary | Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | 3 months | Complete Response (CR) is disappearance of all target lesions. No appearance of new lesions. Partial Response (PR) is a ≥50% decrease in the sum of the product of the longest perpendicular diameters of target lesions, taking as reference the baseline measurements. No appearance of new lesions. No increase of greater than 25% of index lesion. Progressive disease is a ≥25% increase in the sum of the product of the longest perpendicular diameters of target lesions, taking as reference the smallest product on study (this includes the baseline product if that is the smallest on study). In addition to the relative increase of 25%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progression. Non-CR/Non-PD is neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest product of diameters while on study. |
| Secondary | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately 4 months and 17 days. | Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
| Other | Number of Grade 4 Lymphocyte Count Decreased Dose Limiting Toxicities (DLT) | within 30 days of cell infusion | DLT is defined as all treatment related Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL) and greater adverse events occurring within 30 days of the cell infusion with the exception of the following expected transient effects of aldesleukin. Grade 3 fever or chills responsive to symptomatic treatment that resolve to ≤ grade 2 in 48 hours. Grade 3 hypotension or oliguria responsive to ≤ 1.5L of intravenous fluid boluses in 24 hours that resolves to ≤ grade 2 in 48 hours. Grade 3 dyspnea/hypoxia that improves to ≤ grade 2 or less with supplemental oxygen and resolves to ≤ grade 2 without supplemental oxygen in 48 hours. Grade 3 creatinine or electrolyte abnormalities that resolve to ≤ grade 2 in 48 hours. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of E6 T Cell Receptor (TCR) T Cells for the Treatment of Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | within 30 days of cell infusion | cells | NUMBER | |
| SECONDARY | Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Serious and Non-Serious Adverse Events | Date treatment consent signed to date off study, approximately 4 months and 17 days. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Grade 4 Lymphocyte Count Decreased Dose Limiting Toxicities (DLT) | within 30 days of cell infusion | The protocol was amended to exclude Grade 3 or higher white blood cell count decreased/lymphocyte count decreased that resolved to less than Grade 2 in 72 hours. This was done since transient lymphopenia is not a clinically significant event. | Toxicities | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of E6 T Cell Receptor (TCR) T Cells for the Treatment of Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | NA | cells | ||
| Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | Complete Response (CR) | 0 | Participants | |
| Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | Partial Response (PR) | 0 | Participants | |
| Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | Progressive Disease (PD) | 0 | Participants | |
| Number of Participants With a Clinical Response Treated With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (HSIL) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | Non-CR/Non-PD | 1 | Participants | |
| Number of Participants With Serious and Non-Serious Adverse Events | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | Participants | ||
| Number of Grade 4 Lymphocyte Count Decreased Dose Limiting Toxicities (DLT) | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | Toxicities |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | |
| Overall Study | COMPLETED | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | |
| Overall Study | NOT COMPLETED | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 0 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Anxiety | Psychiatric disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Bloating | Gastrointestinal disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Chills | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Edema face | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Edema limbs | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Edema trunk | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Fatigue | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
| other | Fever | General disorders | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 0 | 1 |
| Total, other adverse events | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 1 | 1 |
| Total, serious adverse events | Dose Level -1: 0.7 x 10^10 Transduced T Cells | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03197025
GET https://conductscience.org/api/trials/v1/NCT03197025/registered