Trial Outcomes & Findings for E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer (NCT NCT04476251)
NCT ID: NCT04476251
Last Updated: 2021-12-15
Results Overview
The Fraction of participants for whom E7 T-Cell Receptor (TCR) induction therapy is feasible in participants with cervical cancer
TERMINATED
EARLY_PHASE1
1 participants
6 months
2021-12-15
Participant Flow
Participant milestones
| Measure |
Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy
E7 TCR T Cell Therapy
E7 TCR: Patients will receive up to 3x10\^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells).
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy
E7 TCR T Cell Therapy
E7 TCR: Patients will receive up to 3x10\^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells).
|
|---|---|
|
Overall Study
Not treated
|
1
|
Baseline Characteristics
E7 TCR T Cell Induction Immunotherapy for Stage IIB-IVA Cervical Cancer
Baseline characteristics by cohort
| Measure |
Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy
n=1 Participants
E7 TCR T Cell Therapy
E7 TCR: Patients will receive up to 3x10\^10 E7 T-Cell Receptor (TCR) T cells (i.e. TCR+ cells).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
The Fraction of participants for whom E7 T-Cell Receptor (TCR) induction therapy is feasible in participants with cervical cancer
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yrs and 5 yrsPopulation: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
Fraction of participants with relapse-free survival at 2 years and 5 years estimated from a Kaplan-Meier curve of relapsed free survival following definitive standard of care therapy who achieve a success. Relapsed free survival is defined as the time from date on study to date of relapse of disease.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
To evaluate the safety of E7 induction therapy, the types and grades of toxicity obtained will be reported. Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
Percentage of E7 T-Cell Receptor (TCR)T cells following completion of chemoradiation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
Fraction of participants who achieve an objective response (Partial Response + Complete Response) following E7 induction therapy will be reported. Response may be assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesion; and/or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST). Complete Metabolic Response is complete resolution of F-fluorodeoxyglucose (FDG) uptake in all lesions, and Partial Metabolic Response is ≥ 30% reduction of the SUL (lean body mass corrected standard uptake value) peak and an absolute drop of 0.8 SULpeak units.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, approximately 20 days.Population: This outcome measure was not done due to multiple logistical challenges. One participant was enrolled but not treated.
Here is the number of participants with serious and 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. 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.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1/E7 T-Cell Receptor (TCR) T Cell Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place