Trial · NCT02858310
E7 TCR T Cells for Human Papillomavirus-Associated Cancers
NCT02858310, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2026-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. E7 TCR T Cells for Human Papillomavirus-Associated Cancers. Trials, record NCT02858310. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02858310
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- E7 TCR T Cells for Human Papillomavirus-Associated Cancers
- NCT number
- NCT02858310
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 224 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Papillomavirus Infections, Cervical Intraepithelial Neoplasia, Carcinoma In Situ, Vulvar Neoplasms, Vulvar Diseases
- Interventions
E7 TCR cells, Aldesleukin, Fludarabine, Cyclophosphamide, EKG, Biopsy, Chest CT and MRI or PET, PFT, Granisetron, Ondansetron, Droperidol, Prochlorperazine, Diphenoxylate HCL, Atropine sulfate, Codeine sulfate, Loperamide, Indomethacin, Acetaminophen, Diphenhydramine HCL, Hydroxyzine HCL, Meperidine
- First posted
- 2016-08-08
- Last updated
- 2026-03-09
- Results first posted
- 2026-03-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR) | At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years | Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Compete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. |
| Primary | Phase I: Number of Dose Limiting Toxicities (DLT) | From the day of cell infusion (Day 0) to Day +30 | Adverse events were assessed by the Common Terminology Criteria for Adverse Events v4.0. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event. A DLT is defined as all Grade 3 and greater toxicities occurring within 30 days of the cell infusion with the exception of: Cytokine Release Syndrome (CRS) that resolves ≤ grade 2 within 14 days of the last dose of aldesleukin. Autoimmune toxicity that resolves to ≤ grade 2 within 14 days for starting symptom treatment (e.g. steroids). Cardiac, gastrointestinal, dermatological, hepatic, pulmonary, renal, hematologic, neurologic toxicity, or toxicity in Appendix C of the protocol attributable to aldesleukin that resolves to ≤ grade 2 within 14 days of the last dose of aldesleukin. Transient grade 3 hypoxia associated with cell infusion that corrects to ≤ grade 2 with supplemental oxygen and/or that resolves to ≤ grade 2 within 24 hours or before starting aldesleukin. |
| Secondary | Progression-free Survival | From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months | Progression-free survival is the time from start of treatment to disease progression or death from any cause. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Disease progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progressions. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Adverse Events were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered up to a maximum of 12 months | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for 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. |
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 | Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR) | At 12 weeks, every 3 months x 3, and every 6 months for approximately 5 years | Participants in Phase II only were evaluable for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Phase I: Number of Dose Limiting Toxicities (DLT) | From the day of cell infusion (Day 0) to Day +30 | 194/224 participants enrolled but not treated were not evaluable. | toxicities | NUMBER |
| SECONDARY | Progression-free Survival | From the time of cell infusion (Day 0) until documented progressive disease; a maximum of 12 months | 24/224 participants were analyzed because 200 were not evaluable for this outcome. | Months | MEDIAN |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | Adverse Events were monitored/assessed from the first study intervention, Study Day 0, through 40 days after the study therapy was last administered up to a maximum of 12 months | 194/224 participants enrolled but not treated were not evaluable for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group73
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR) | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | Complete Response | 0 | Participants | |
| Phase II: Overall Response Rate Partial Response + Complete Response (PR +CR) | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | Partial Response | 5 | Participants | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | Hypoxia-Grade 4- Serious | 0 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | Hypoxia-Grade 4- Serious | 0 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | Hypoxia-Grade 4- Serious | 1 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | Respiratory Failure-Grade 4- Serious | 0 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | Respiratory Failure-Grade 4- Serious | 0 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | Respiratory Failure-Grade 4- Serious | 1 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | Hypotension-Grade 4-Serious | 0 | toxicities | |
| Phase I: Number of Dose Limiting Toxicities (DLT) | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | Hypotension-Grade 4-Serious | 0 | toxicities |
1 to 10 of 73Source ClinicalTrials.gov
See all 73 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I Dose Escalation | STARTED | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 3 | |
| Phase I Dose Escalation | STARTED | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 | |
| Phase I Dose Escalation | STARTED | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 | |
| Phase I Dose Escalation | STARTED | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 0 | |
| Phase I Dose Escalation | STARTED | Participants Enrolled But Were Not Treated | 36 | |
| Phase I Dose Escalation | COMPLETED | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 3 | |
| Phase I Dose Escalation | COMPLETED | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 | |
| Phase I Dose Escalation | COMPLETED | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 | |
| Phase I Dose Escalation | COMPLETED | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 0 | |
| Phase I Dose Escalation | COMPLETED | Participants Enrolled But Were Not Treated | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events985
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 distension | Gastrointestinal disorders | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 0 | 3 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 1 | 6 | 2 |
| other | Abdominal distension | Gastrointestinal disorders | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 3 | 18 | 4 |
| other | Abdominal distension | Gastrointestinal disorders | Participants Enrolled But Were Not Treated | 0 | 0 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 1 | 3 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 3 | 6 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 2 | 18 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Participants Enrolled But Were Not Treated | 0 | 0 | 0 |
1 to 10 of 985Source ClinicalTrials.gov
See all 985 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 0 | 3 |
| Total, all-cause mortality | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 0 | 3 |
| Total, all-cause mortality | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 0 | 6 |
| Total, all-cause mortality | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 0 | 18 |
| Total, all-cause mortality | Participants Enrolled But Were Not Treated | 5 | 194 |
| Total, other adverse events | Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells | 3 | 3 |
| Total, other adverse events | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells | 3 | 3 |
| Total, other adverse events | Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells | 6 | 6 |
| Total, other adverse events | Phase II Cohort; Arm 2: Phase II: 1 x 10^11 E7 Cells | 18 | 18 |
| Total, other adverse events | Participants Enrolled But Were Not Treated | 0 | 0 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT02858310
GET https://conductscience.org/api/trials/v1/NCT02858310/results?page=2