Trial Outcomes & Findings for A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer (NCT NCT05451849)
NCT ID: NCT05451849
Last Updated: 2026-07-13
Results Overview
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
Results posted on
2026-07-13
Participant Flow
Fourteen (14) participants were screened and subsequently underwent leukapheresis in Phase 1 (Intent-to-Treat population). Six (6) participants received lymphodepleting chemotherapy and were dosed in Phase 1 (modified Intent-to-Treat population). No participants were subsequently included in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Participant milestones
| Measure |
Phase 1
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Overall Study
STARTED
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14
|
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Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Phase 1
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Overall Study
Did not meet eligibility criteria prior to lymphodepletion and dosing
|
8
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Baseline Characteristics
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Baseline characteristics by cohort
| Measure |
Phase 1
n=6 Participants
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Age, Customized
Mean Age
|
54 Years
n=20 Participants
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Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Tumor type
MPM
|
3 Participants
n=20 Participants
|
|
Tumor type
Pancreatic
|
2 Participants
n=20 Participants
|
|
Tumor type
Ovarian
|
1 Participants
n=20 Participants
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PRIMARY outcome
Timeframe: From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)Population: The modified ITT Population included all participants enrolled and treated with TC-510.
TEAEs are defined as AEs that were reported or worsened on or after the first administration of protocol-defined lymphodepleting chemotherapy through 3 months after the last infusion of TC-510. To be defined as serious, the event met at least one of the following serious criteria: * Fatal * Life-threatening (places the patient at immediate risk of death) * Requires in-patient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Congenital anomaly/birth defect * Other medically important serious event
Outcome measures
| Measure |
Phase 1
n=6 Participants
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with any TEAEs · TEAE Grade >= 3
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with any TEAEs related to TC-510 · TEAE Grade >= 3
|
6 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with any TEAEs Grade >=3 related to TC-510 · TEAE Grade >= 3
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with any Serious TEAEs · TEAE Grade >= 3
|
4 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with Serious TEAEs related to TC-510 · TEAE Grade >= 3
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Subjects with any Serious TEAEs >=Grade 3 related to TC-510 · TEAE Grade >= 3
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2 Participants
|
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Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Participants with any Serious TEAEs with fatal outcome · TEAE Grade >= 3
|
0 Participants
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SECONDARY outcome
Timeframe: From first TC-510 infusion through study completion (up to approximately 38 months)Population: The modified ITT Population included all participants enrolled and treated with TC-510.
ORR is the proportion of patients with a Complete Response (CR) or Partial Response (PR) via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
Outcome measures
| Measure |
Phase 1
n=6 Participants
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Overall Response Rate (ORR)
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1 Participants
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SECONDARY outcome
Timeframe: From first TC-510 infusion through study completion (up to approximately 38 months)Population: The modified ITT Population included all participants enrolled and treated with TC-510.
DCR is defined as the ORR plus the proportion of patients with Stable Disease (SD) for at least 8 weeks via independently reviewed RECIST v 1.1 relative to the total number of patients in the mITT population.
Outcome measures
| Measure |
Phase 1
n=6 Participants
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Disease Control Rate (DCR)
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2 Participants
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Adverse Events
Phase 1
Serious events: 4 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1
n=6 participants at risk
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Immune system disorders
Cytokine Release Syndrome
|
33.3%
2/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
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Immune system disorders
Pneumonitis
|
33.3%
2/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
Other adverse events
| Measure |
Phase 1
n=6 participants at risk
Eligible participants underwent leukapheresis to manufacture engineered T cells. Prior to dosing, participants had to remain eligible and, prior to dosing, were given lymphodepleting chemotherapy (fludarabine and cyclophosphamide). Six (6) participants were dosed once with a mean total of 50.7 x 10\^7 TC-510 T cells (mITT population). All subjects completed the interventional phase of the trial.
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|---|---|
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Vascular disorders
Hypotension
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Immune system disorders
Cytokine Release Syndrome
|
83.3%
5/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
50.0%
3/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic Pain
|
50.0%
3/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
50.0%
3/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Respiratory, thoracic and mediastinal disorders
Dypsnoea
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
2/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Aspartate aminotransferas increased
|
33.3%
2/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Lipase increased
|
33.3%
2/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Amylase increased
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Blood alkaline phosphatase increased
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Investigations
Troponin I increased
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Gastrointestinal disorders
Pancreatitis
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
|
|
General disorders
Fatigue
|
16.7%
1/6 • From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
The modified ITT Population included all participants enrolled and treated with TC-510.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place