MesotheliomaPhase 1/2NCT03907852
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 study testing gavo-cel, fludarabine and cyclophosphamide in people with Mesothelioma and Mesothelioma, Malignant, run by TCR2 Therapeutics at 11 sites in 2 countries.
Trial summary
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing 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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma, Mesothelioma, Malignant, Mesothelioma; Pleura
- What is being tested?
- gavo-cel, fludarabine and cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 15 Apr 2019to 2 Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 at least 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC) at screening.
- Patient's tumor has been pathologically reviewed by the central laboratory. For Serous Ovarian Adenocarcinoma, patients must have confirmed positive MSLN expression on >/= 30% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry (IHC). Ovarian patients will subsequently be stratified into two groups: high MSLN expression (>/= 50% of tumor cells that are 2+ and/or 3+) or low MSLN expression (>/= 30% of tumor cells that are 1+, 2+, and/or 3+ not meeting criteria for the high MSLN expression group). MPM patients must have MSLN expression of >/= 50% of tumor cells that are 2+ and/or 3+ by IHC. Cholangiocarcinoma and NSCLC patients must have MSLN expression of >/= 30% of tumor cells that are 1+, 2+, and/or 3+ by IHC.
- Prior to gavo-cel infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease, with the exception of Cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. Regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). More details provided in the clinical protocol.
- Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
- Patient has a left ventricular ejection fraction > 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion.
- 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
None listed.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States10 sites
National Cancer Institute
Bethesda, Maryland, 20814
University of Chicago Medical Center
Chicago, Illinois, 60637
Duke University
Durham, North Carolina, 27705
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of Miami Sylvester Cancer Center
Miami, Florida, 33136
SCRI Oncology Partners
Nashville, Tennessee, 37203
Columbia University Medical Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing 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.
This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.
- Conditions
- Mesothelioma, Mesothelioma, Malignant, Mesothelioma; Pleura, Mesotheliomas Pleural, Mesothelioma Peritoneum, Cholangiocarcinoma
- Being tested
- gavo-cel, fludarabine, cyclophosphamide, Nivolumab, Ipilimumab
- Medical subject headings
- Mesothelioma, Mesothelioma, Malignant, Cholangiocarcinoma, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gavo-celBiological
gavo-cel
fludarabineDrug
lymphodepletion chemotherapy
cyclophosphamideDrug
lymphodepletion chemotherapy
NivolumabDrug
immuno-oncology agent
IpilimumabDrug
immuno-oncology agent
| Study group | Role | What they receive |
|---|---|---|
| Lymphodepletion followed by gavo-cel | Experimental | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel Receives: Biological: gavo-cel; Drug: fludarabine; Drug: cyclophosphamide |
| Lymphodepletion followed by gavo-cel plus nivolumab | Experimental | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel Receives: Biological: gavo-cel; Drug: fludarabine; Drug: cyclophosphamide; Drug: Nivolumab |
| Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab | Experimental | fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel Receives: Biological: gavo-cel; Drug: fludarabine; Drug: cyclophosphamide; Drug: Nivolumab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1- Primary Objective
Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Measured: DLTs within 28 days post-treatment
Phase 2- Primary Objective
To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).
Measured: ORR at 3 months; DCR based on ORR + SD lasting at least 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Apr 2019
- Primary completion19 Nov 2024
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCR2 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907852
- Sponsor's protocol ID
- TCR2-18-01
- Status last verified
- Aug 2025
- First submitted
- 1 Apr 2019
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hassan R, Butler M, O'Cearbhaill RE, Oh DY, Johnson M, Zikaras K, Smalley M, Ross M, Tanyi JL, Ghafoor A, Shah NN, Saboury B, Cao L, Quintas-Cardama A, Hong D. Mesothelin-targeting T cell receptor fusion construct cell therapy in refractory solid tumors: phase 1/2 trial interim results. Nat Med. 2023 Aug;29(8):2099-2109. doi: 10.1038/s41591-023-02452-y. Epub 2023 Jul 27.
PubMed 37501016
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. 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 Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
- ClinicalTrials.gov ID
- NCT03907852
- Acronym / sponsor ID
- TCR2-18-01
- Conditions
- Mesothelioma, Mesothelioma, Malignant, Mesothelioma; Pleura, Mesotheliomas Pleural, Mesothelioma Peritoneum, Cholangiocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 57 participants (actual)
- Lead sponsor
- TCR2 TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Bristol-Myers Squibb
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 19 Nov 2024 (actual)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing 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.
This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lymphodepletion followed by gavo-cel | Experimental | Biological: gavo-cel, Drug: fludarabine, Drug: cyclophosphamidefludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel |
| Lymphodepletion followed by gavo-cel plus nivolumab | Experimental | Biological: gavo-cel, Drug: fludarabine, Drug: cyclophosphamide, Drug: Nivolumabfludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel |
| Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab | Experimental | Biological: gavo-cel, Drug: fludarabine, Drug: cyclophosphamide, Drug: Nivolumab, Drug: Ipilimumabfludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is at least 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC) at screening.
- Patient's tumor has been pathologically reviewed by the central laboratory. For Serous Ovarian Adenocarcinoma, patients must have confirmed positive MSLN expression on >/= 30% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry (IHC). Ovarian patients will subsequently be stratified into two groups: high MSLN expression (>/= 50% of tumor cells that are 2+ and/or 3+) or low MSLN expression (>/= 30% of tumor cells that are 1+, 2+, and/or 3+ not meeting criteria for the high MSLN expression group). MPM patients must have MSLN expression of >/= 50% of tumor cells that are 2+ and/or 3+ by IHC. Cholangiocarcinoma and NSCLC patients must have MSLN expression of >/= 30% of tumor cells that are 1+, 2+, and/or 3+ by IHC.
- Prior to gavo-cel infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease, with the exception of Cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. Regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). More details provided in the clinical protocol.
- Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| gavo-celgavo-cel | Biological | Lymphodepletion followed by gavo-cel, Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab |
| fludarabinelymphodepletion chemotherapy | Drug | Lymphodepletion followed by gavo-cel, Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab |
| cyclophosphamidelymphodepletion chemotherapy | Drug | Lymphodepletion followed by gavo-cel, Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab |
| Nivolumabimmuno-oncology agent | Drug | Lymphodepletion followed by gavo-cel plus nivolumab, Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab |
| Ipilimumabimmuno-oncology agent | Drug | Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab |
Primary outcome
Phase 1- Primary Objective
Time frame: DLTs within 28 days post-treatment
Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Phase 2- Primary Objective
Time frame: ORR at 3 months; DCR based on ORR + SD lasting at least 8 weeks
To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 37501016Hassan R, Butler M, O'Cearbhaill RE, Oh DY, Johnson M, Zikaras K, Smalley M, Ross M, Tanyi JL, Ghafoor A, Shah NN, Saboury B, Cao L, Quintas-Cardama A, Hong D. Mesothelin-targeting T cell receptor fusion construct cell therapy in refractory solid tumors: phase 1/2 trial interim results. Nat Med. 2023 Aug;29(8):2099-2109. doi: 10.1038/s41591-023-02452-y. Epub 2023 Jul 27.
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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.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gavo-cel, fludarabine and cyclophosphamide in people with Mesothelioma and Mesothelioma, Malignant, run by TCR2 Therapeutics at 11 sites in 2 countries.
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 8 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Phase 1- Primary Objective (time frame: DLTs within 28 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03907852, which also lists 1 linked publication.
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 27 Aug 2025.