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Trial record 1 of 1 for:    19-C-0091 OR 19C0091
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Immunotherapy With E7 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions

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ClinicalTrials.gov Identifier: NCT03937791
Recruitment Status : Terminated (All analysis with identifiable specimens/data is complete or site has no identifiers linked to the specimens/data. The one enrolled pt has been taken off study)
First Posted : May 6, 2019
Results First Posted : March 18, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
Scott Norberg, D.O., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Lntraepithelial Lesions of Vulva
Neoplasms, Squamous Cell
Vulvar HSIL
Intervention Biological: E7 T Cell Receptor (TCR)
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description

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 Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
59.2  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
1
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
1
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title 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
Hide Description The fraction of patients who experience a complete response. Complete Response is disappearance of all target lesions. No appearance of new lesions.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of participants
0
2.Secondary Outcome
Title 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
Hide Description Grade 2 adverse event is moderate.
Time Frame 30 days following the last dose of study therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Number
Unit of Measure: adverse events
1
3.Other Pre-specified Outcome
Title Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Hide Description 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 Frame Date treatment consent signed to date off study, approximately 8 months and 6 days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description:

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 Number of Participants Analyzed 1
Measure Type: Count of Participants
Unit of Measure: Participants
1
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 8 months and 6 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Hide Arm/Group Description

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.

All-Cause Mortality
Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Affected / at Risk (%)
Total   0/1 (0.00%)    
Hide Serious Adverse Events
Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1/1x10^11 E7 T Cell Receptor (TCR) T Cells
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Reproductive system and breast disorders   
Vaginal pain  1  1/1 (100.00%)  1
1
Term from vocabulary, CTCAE (5.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Norberg, D.O.
Organization: National Cancer Institute
Phone: 301-275-9668
EMail: scott.norberg@mail.nih.gov
Layout table for additonal information
Responsible Party: Scott Norberg, D.O., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03937791    
Other Study ID Numbers: 190091
19-C-0091
First Submitted: May 3, 2019
First Posted: May 6, 2019
Results First Submitted: February 24, 2021
Results First Posted: March 18, 2021
Last Update Posted: April 13, 2021