NCT05194735 · ADVERSE EVENTS

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.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.
Other-event reporting threshold: 0%

Adverse events (AEs) were collected from initiation of lymphodepletion through 28 days after TCR-T cell infusion and during long-term follow-up for up to 1 year. AEs were graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 and coded using the Medical Dictionary for Regulatory Activities (MedDRA). Treatment-emergent adverse events (TEAEs) were defined as those that began or worsened after initiation of lymphodepletion.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	1 / 1	1 / 1	1 / 1
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.	2 / 7	7 / 7	6 / 7
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.	0 / 0	0 / 0	0 / 0

Group identifiers: EG000: Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells) · EG001: Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells) · EG002: Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Anaemia post chemotherapy
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Febrile neutropenia

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
7
num Events
4
group Id
EG002
num At Risk
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
7
num Events
5
group Id
EG002
num At Risk
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
4
num At Risk
7
num Events
6
group Id
EG002
num At Risk
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
5
group Id
EG001
num Affected
7
num At Risk
7
num Events
36
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
4
group Id
EG002
num At Risk
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
3
num At Risk
7
num Events
5
group Id
EG002
num At Risk
0
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Blood fibrinogen increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num At Risk
0
term
Cancer fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
3
num At Risk
7
num Events
3
group Id
EG002
num At Risk
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Constipation

Complete source fields

description

event Groups

deaths Num Affected
1
deaths Num At Risk
1
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
EG000
other Num Affected
1
other Num At Risk
1
serious Num Affected
1
serious Num At Risk
1
title
Assigned Dose Level 1 (Target 5 × 10⁹ TCR+ Cells)
deaths Num Affected
6
deaths Num At Risk
7
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
EG001
other Num Affected
7
other Num At Risk
7
serious Num Affected
2
serious Num At Risk
7
title
Assigned Dose Level 2 (Target 40 × 10⁹ TCR+ Cells)
deaths Num Affected
0
deaths Num At Risk
0
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
EG002
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Assigned Dose Level 3 (Target 100 × 10⁹ TCR+ Cells)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
7
num Events
4
group Id
EG002
num At Risk
0
term
Activated partial thromboplastin time prolonged
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
4
num At Risk
7
num Events
5
group Id
EG002
num At Risk
0
term
Alanine aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
4
num At Risk
7
num Events
6
group Id
EG002
num At Risk
0
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
5
group Id
EG001
num Affected
7
num At Risk
7
num Events
36
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
4
group Id
EG002
num At Risk
0
term
Aspartate aminotransferase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
3
num At Risk
7
num Events
5
group Id
EG002
num At Risk
0
term
Blood alkaline phosphatase increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Blood fibrinogen increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
0
num At Risk
1
num Events
0
group Id
EG001
num Affected
1
num At Risk
7
num Events
1
group Id
EG002
num At Risk
0
term
Cancer fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
3
num At Risk
7
num Events
3
group Id
EG002
num At Risk
0
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Constipation

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
2
num At Risk
7
num Events
2
group Id
EG002
num At Risk
0
term
Cytokine release syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Hypotension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Hypoxia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
2
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
notes
Anaemia post chemotherapy
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (26.0)
stats
group Id
EG000
num Affected
1
num At Risk
1
num Events
1
group Id
EG001
num Affected
0
num At Risk
7
num Events
0
group Id
EG002
num At Risk
0
term
Febrile neutropenia

time Frame

From initiation of lymphodepletion until the participant's final study visit, up to approximately 1 year after TCR-T cell infusion.

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