NCT02858310 · OUTCOME

Phase I: Number of Dose Limiting Toxicities (DLT)

E7 TCR T Cells for Human Papillomavirus-Associated Cancers · Source last updated 2026-03-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: NUMBER
Unit: toxicities
Interval / dispersion: Not reported
Time frame: From the day of cell infusion (Day 0) to Day +30

What was measured

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.

Analysis population: 194/224 participants enrolled but not treated were not evaluable.

Groups in this outcome

Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells

Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.

Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells

Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.

Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells

Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
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 Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	3
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	6

Reported measurements

Hypoxia-Grade 4- Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Respiratory Failure-Grade 4- Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Hypotension-Grade 4-Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Acute Kidney Injury- Grade 4- Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Delirium-Grade 3-Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Dysphagia-Grade 3-Serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Acidosis- Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Hyperkalemia-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased-Grade 4-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Alanine aminotransferase increased-Grade 3- Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased-Grade 4-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Aspartate aminotransferase increased-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

CPK increased-Grade 4-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

CPK increased-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Blood bilirubin increased-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Acute kidney injury-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Peripheral ischemia-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Anxiety-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Hypophosphatemia-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Generalized muscle weakness-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Hypokalemia-Grade 3-Non-serious

Values in toxicities · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells	0	Not reported	Not reported	Not reported	Not reported
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Hypoxia-Grade 4- Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Respiratory Failure-Grade 4- Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Hypotension-Grade 4-Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Acute Kidney Injury- Grade 4- Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Delirium-Grade 3-Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Dysphagia-Grade 3-Serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Acidosis- Grade 3-Non-serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Hyperkalemia-Grade 3-Non-serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Alanine aminotransferase increased-Grade 4-Non-serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Alanine aminotransferase increased-Grade 3- Non-serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Aspartate aminotransferase increased-Grade 4-Non-serious
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
group Id
OG002
value
1
title
Aspartate aminotransferase increased-Grade 3-Non-serious

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
6
units
Participants

description

groups

description
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 1: 1 x 10\^9 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
id
OG000
title
Phase I:Dose Escalation Cohort; Arm 1:Phase I:DoseLevel 1: 1 x 10^9 E7 T-Cell Receptor (TCR) Cells
description
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 2: 1 x 10\^10 E7 T-Cell Receptor (TCR) Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 TCR cells at escalating doses, followed by Aldesleukin.
id
OG001
title
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 2: 1 x 10^10 E7 T-Cell Receptor Cells
description
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level (DL) 3: 1 x 10\^11 E7 Cells. Arm 1, Phase I, Non-myeloablative, lymphocyte depleting preparative regimen, followed by E7 T-Cell Receptor (TCR) Cells at escalating doses, followed by Aldesleukin.
id
OG002
title
Phase I: Dose Escalation Cohort; Arm 1: Phase I; Dose Level 3: 1 x 10^11 E7 Cells

param Type

NUMBER

population Description

194/224 participants enrolled but not treated were not evaluable.

reporting Status

POSTED

time Frame

From the day of cell infusion (Day 0) to Day +30

title

Phase I: Number of Dose Limiting Toxicities (DLT)

type

PRIMARY

unit Of Measure

toxicities

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Preserved source evidence · Not medical advice