NCT05194735 · OUTCOME

Number of Participants With Treatment-Emergent Adverse Events

Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors · Source last updated 2025-11-10

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

Measure: NUMBER
Unit: participants
Interval / dispersion: Not reported
Time frame: From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.

What was measured

Treatment-emergent adverse events (TEAEs) were defined as any adverse event that began or worsened after initiation of lymphodepletion and up to 28 days following TCR-T cell infusion. TEAEs were coded using MedDRA and summarized by system organ class and preferred term, severity, and relationship to study treatment. Participants were followed for delayed or ongoing toxicities for up to 1 year.

Analysis population: Participants who received a TCR-T cell infusion (Safety Analysis Set).

Groups in this outcome

Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.

Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.

Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.

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
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	7
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)	0

Reported measurements

Any TEAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1	Not reported	Not reported	Not reported	Not reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	7	Not reported	Not reported	Not reported	Not reported

Drug-related TEAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1	Not reported	Not reported	Not reported	Not reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	7	Not reported	Not reported	Not reported	Not reported

Drug-related Grade 3 or higher TEAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1	Not reported	Not reported	Not reported	Not reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	6	Not reported	Not reported	Not reported	Not reported

TEAE leading to death

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	0	Not reported	Not reported	Not reported	Not reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	0	Not reported	Not reported	Not reported	Not reported

Treatment-emergent SAE

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)	1	Not reported	Not reported	Not reported	Not reported
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)	2	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
title
Any TEAE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
7
title
Drug-related TEAE
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
6
title
Drug-related Grade 3 or higher TEAE
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
TEAE leading to death
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
2
title
Treatment-emergent SAE

denoms

counts
group Id
OG000
value
1
group Id
OG001
value
7
group Id
OG002
value
0
units
Participants

description

groups

description
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 1 (target 5 (1 to \<10) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the lowest dose cohort in the sequential dose-escalation design.
id
OG000
title
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
description
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 2 (target 40 (10 to \<70) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the intermediate dose cohort in the sequential dose-escalation design.
id
OG001
title
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
description
Participants received a single intravenous infusion of autologous TCR-T cells manufactured at Dose Level 3 (target 100 (70 to 100) × 10⁹ TCR+ cells) following apheresis and manufacturing per protocol. This represents the highest dose cohort in the sequential dose-escalation design.
id
OG002
title
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

param Type

NUMBER

population Description

Participants who received a TCR-T cell infusion (Safety Analysis Set).

reporting Status

POSTED

time Frame

From initiation of lymphodepletion through Day 28 after TCR-T cell infusion, and through long-term follow-up for up to 1 year.

title

Number of Participants With Treatment-Emergent Adverse Events

type

PRIMARY

unit Of Measure

participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice