Trial Outcomes & Findings for Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions (NCT NCT03937791)

Last Updated: 2021-04-13

Results Overview

The fraction of patients who experience a complete response. Complete Response is disappearance of all target lesions. No appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

3 months

Results posted on

2021-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells 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.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells n=1 Participants 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.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 0 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	1 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

The fraction of patients who experience a complete response. Complete Response is disappearance of all target lesions. No appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells n=1 Participants 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.
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	0 Proportion of participants

SECONDARY outcome

Timeframe: 30 days following the last dose of study therapy

Grade 2 adverse event is moderate.

Outcome measures

Outcome measures
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells n=1 Participants 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.
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	1 adverse events

OTHER_PRE_SPECIFIED outcome

Timeframe: Date treatment consent signed to date off study, approximately 8 months and 6 days.

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.

Outcome measures

Outcome measures
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells n=1 Participants 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.
Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	1 Participants

Adverse Events

Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells n=1 participants at risk 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.
Reproductive system and breast disorders Vaginal pain	100.0% 1/1 • Number of events 1 • Date treatment consent signed to date off study, approximately 8 months and 6 days.

Additional Information

Scott Norberg, D.O.

National Cancer Institute

Phone: 301-275-9668

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place