MesotheliomaPhase 1/2NCT05451849
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 study testing TC-510, Fludarabine and Cyclophosphamide in people with Mesothelioma and Mesotheliomas Pleural, run by TCR2 Therapeutics at 7 sites in United States.
Trial summary
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma, Malignant
- What is being tested?
- TC-510, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 7 sitesUnited States
- Study dates
- 21 Jun 2022to 30 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is > 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
- Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
- Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
- Patients has an ECOG performance status 0 or 1
- Patient is fit for leukapheresis and has adequate venous access for the cell collection.
- Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
Who cannot join
- Inability to follow the procedures of the study
- Known or suspected non-compliance, drug, or alcohol use
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
National Cancer Institute
Bethesda, Maryland, 20814
University of Miami
Miami, Florida, 33146
University of Minnesota, Masonic Cancer Center
Minneapolis, Minnesota, 55455
SCRI Oncology Partners
Nashville, Tennessee, 37203
University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of California, San Francisco
San Franciso, California, 94143
Montefiore Einstein Cancer Center
The Bronx, New York, 10461
About this study
Official title: A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.
- Conditions
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma, Malignant, Mesothelioma Peritoneum, Ovarian Cancer, Ovarian Serous Adenocarcinoma
- Being tested
- TC-510, Fludarabine, Cyclophosphamide
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant, Ovarian Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Triple Negative Breast Neoplasms, Cholangiocarcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-510Biological
TC-510
FludarabineDrug
Fludarabine
CyclophosphamideDrug
Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Lymphodepletion followed by TC-510 | Experimental | Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells Receives: Biological: TC-510; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
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
Measured: From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
Secondary outcomes (2)
Overall Response Rate (ORR)
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.
Measured: From first TC-510 infusion through study completion (up to approximately 38 months)
Disease Control Rate (DCR)
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.
Measured: From first TC-510 infusion through study completion (up to approximately 38 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start21 Jun 2022
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Why it stopped: No participants were enrolled in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCR2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451849
- Sponsor's protocol ID
- TCR2-21-01
- Status last verified
- Jun 2026
- First submitted
- 21 Jun 2022
- Last updated
- 13 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
- ClinicalTrials.gov ID
- NCT05451849
- Acronym / sponsor ID
- TCR2-21-01
- Conditions
- Mesothelioma, Mesotheliomas Pleural, Mesothelioma, Malignant, Mesothelioma Peritoneum, Ovarian Cancer, Ovarian Serous Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No participants were enrolled in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- TCR2 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphodepletion followed by TC-510 | Experimental | Biological: TC-510, Drug: Fludarabine, Drug: CyclophosphamideLymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is > 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
- Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
- Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
- Patients has an ECOG performance status 0 or 1
Key exclusion criteria (2 listed)
- Inability to follow the procedures of the study
- Known or suspected non-compliance, drug, or alcohol use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-510TC-510 | Biological | Lymphodepletion followed by TC-510 |
| FludarabineFludarabine | Drug | Lymphodepletion followed by TC-510 |
| CyclophosphamideCyclophosphamide | Drug | Lymphodepletion followed by TC-510 |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs
Time frame: From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)
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
2 secondary outcomes
Overall Response Rate (ORR)
Time frame: From first TC-510 infusion through study completion (up to approximately 38 months)
Disease Control Rate (DCR)
Time frame: From first TC-510 infusion through study completion (up to approximately 38 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TC-510, Fludarabine and Cyclophosphamide in people with Mesothelioma and Mesotheliomas Pleural, run by TCR2 Therapeutics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious TEAEs (time frame: From start of lymphodepleting chemotherapy through end of the interventional phase (up to approximately 38 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.