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Metastatic Pancreatic Ductal AdenocarcinomaPhase 1NCT04809766

Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma

A Phase 1 study testing Autologous Mesothelin-specific TCR-T Cells, Cyclophosphamide and Fludarabine in people with Metastatic Pancreatic Ductal Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase I trial evaluates the side effects and best dose of mesothelin-specific T-cells (FH-TCR-Tᴍsʟɴ) in treating patients with pancreatic ductal adenocarcinoma that has spread to other places in the body (metastatic). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous Mesothelin-specific TCR-T Cells, Cyclophosphamide and Fludarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
14 Dec 2021to 15 Jan 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • LEUKAPHERESIS: Tissue confirmation of pancreatic ductal adenocarcinoma and expression of mesothelin (MSLN): Participants must have metastatic disease. Confirmation of diagnosis must be or have been performed by internal pathology review of archival, initial or subsequent biopsy or other pathologic material at Fred Hutchinson Cancer Research Center (Fred Hutch)/University of Washington (UW). Baseline tissue will be stained by immunohistochemistry (IHC) to confirm MSLN expression
  • LEUKAPHERESIS: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease. Baseline imaging (for example diagnostic computed tomography [CT] chest/abdomen/pelvis) must be obtained within 28 days prior to start of first planned FHMSLN-TCR infusion. Magnetic resonance imaging (MRI) can be substituted for CT in patients unable to have CT contrast
  • LEUKAPHERESIS: Previous treatment with chemotherapy: Patients may have been previously treated with at least one prior line of systemic therapy for metastatic disease
  • LEUKAPHERESIS: Human leukocyte antigen (HLA) type HLA-A*02:01: Participants must be HLA-A*02:01 in order for the infused transgenic T cells to recognize antigen-major histocompatibility complex (MHC) complexes on their tumor. HLA typing should be determined though a molecular approach in a clinical laboratory licensed for HLA typing
  • LEUKAPHERESIS: Life expectancy must be > 3 months at trial entry
  • LEUKAPHERESIS: 18 years or older
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  • LEUKAPHERESIS: Capable of understanding and providing a written informed consent
  • LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • LEUKAPHERESIS: Tumor tissue amenable to safe biopsy and subject willing to undergo serial tumor biopsies at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion (prior to second T cell infusion), and approximately 2 weeks +/- 1 week after the 3rd infusion, if safe and feasible (these windows may vary due to manufacturing or clinical reasons): Should there be no tumor tissue that is accessible for biopsy, patients will still be considered for participation, at discretion of the investigator. Similarly, should an investigator determine that a biopsy cannot be performed safely for clinical reasons, biopsies may be cancelled or rescheduled. For subjects who do not have sufficient T cells for three T cell infusion, a tumor tissue biopsy will be performed at baseline (prior to the 1st T cell infusion), 2-3 weeks after the 1st infusion, and approximately 2 weeks +/- 1 week after the 2nd infusion (if applicable), if safe and feasible.
  • LEUKAPHERESIS: Participants must be at least 3 weeks from last systemic treatment for metastatic disease: At least 3 weeks must have passed since any: immunotherapy (for example, T cell infusions, immunomodulatory agents, interleukins, vaccines), small molecule or chemotherapy cancer treatment, other investigational agents. There is no washout period for radiation, as long as the irradiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates are permitted but concurrent treatment with RANK-ligand inhibitors (i.e., denosumab) is not permitted within 8 weeks of treatment
  • LEUKAPHERESIS: Estimated glomerular filtration rate (eGFR) > 60 mL/min
  • LEUKAPHERESIS: Total bilirubin (bili) =< 1.5 X ULN. Patients with suspected Gilbert syndrome may be included if total bili > 3 mg/dL but no other evidence of hepatic dysfunction
  • LEUKAPHERESIS: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 5 x ULN
  • LEUKAPHERESIS: =< grade 1 dyspnea and oxygen saturation (SaO2) >= 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, patients with forced expiratory volume in 1 second (FEVI) >= 50% of predicted and carbon monoxide diffusing capability test (DLCO) (corrected) of >= 40% of predicted will be eligible
  • LEUKAPHERESIS: Patients >= 60 years of age are required to have left ventricular ejection fraction (LVEF) evaluation performed within 1 year prior to study treatment. LVEF may be established with echocardiogram or multigated acquisition scan (MUGA) scan, and left ejection fraction must be >= 35%. Cardiac evaluation for other patients is at the discretion of the treating physician
  • LEUKAPHERESIS: Absolute neutrophil count (ANC) > 1500 cells/ mm^3
  • LEUKAPHERESIS: Albumin ≥ 2.7 g/dL
  • LEUKAPHERESIS: Negative serum pregnancy test within 14 days before enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
  • LEUKAPHERESIS: Fertile male and female patients must be willing to use an effective contraceptive method before, during, and for at least 4 months after the FH-TCR-TMSLN infusion
  • TREATMENT: Measurable disease by RECIST 1.1 criteria: Participants must have measurable disease. Baseline imaging (for example diagnostic CT chest/abdomen/pelvis) must be obtained within 28 days prior to start of first planned FH-TCR-TMsLN infusion. MRI can be substituted for CT in patients unable to have CT contrast
  • TREATMENT: Life expectancy must be > 3 months at trial entry
  • TREATMENT: ECOG performance status of 0 or 1
  • TREATMENT: Participants must be at least 3 weeks from last systemic treatment for metastatic disease: At least 3 weeks must have passed since any: immunotherapy (for example, T cell infusions, immunomodulatory agents, interleukins, vaccines), small molecule or chemotherapy cancer treatment, other investigational agents. There is no washout period for radiation, as long as the irradiated lesion is not the lesion being evaluated for RECIST measurements on the protocol. Bisphosphonates are permitted but concurrent treatment with RANK-ligand inhibitors (i.e., denosumab) is not permitted within 8 weeks of treatment
  • TREATMENT: eGFR > 60 mL/min
  • TREATMENT: Total bili : =< 1.5 X ULN
  • Patients with suspected Gilbert syndrome may be included if total bili > 3 mg/dL but no other evidence of hepatic dysfunction
  • TREATMENT: AST and ALT< 5 x ULN
  • TREATMENT: Grade 1 dyspnea and SaO2 2: 92% on ambient air. If PFTs are performed based on the clinical judgement of the treating physician, subjects with FEVI 2: 50% of predicted and DLCO (corrected) of 2: 40% of predicted will be eligible
  • TREATMENT: ANC > 1500 cells/mm^3
  • TREATMENT: Platelets (PLT) > 75000/mm^3
  • TREATMENT: Albumin ≥ 2.7 g/dL
  • TREATMENT: Negative serum pregnancy test within 14 days before treatment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year

Who cannot join

  • LEUKAPHERESIS: Expression of HLA B*1302: Participants will be excluded due to the risk of alloreactivity to this allele
  • LEUKAPHERESIS: Pregnancy or lactation
  • LEUKAPHERESIS: Active autoimmune disease: Patients with active autoimmune disease requiring immunosuppressive therapy are excluded. Case by case exemptions are possible with approval by principal investigator (PI)
  • LEUKAPHERESIS: Prior solid organ transplant or allogeneic hematopoietic stem cell transplant
  • LEUKAPHERESIS: Corticosteroid therapy at a dose equivalent of > 0.5 mg/kg of prednisone per day
  • LEUKAPHERESIS: Concurrent use of other investigational anti-cancer agents
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  • LEUKAPHERESIS: Active uncontrolled infection: Human immunodeficiency virus (HIV) positive participants on highly active antiretroviral therapy (HAART) with a CD4 count > 500 cells/mm^3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have hepatitis well controlled on medication
  • LEUKAPHERESIS: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • LEUKAPHERESIS: Untreated brain metastases: Participants with small asymptomatic brain metastases (< 1 cm) or those with brain metastases previously treated and controlled with surgery or radiotherapy will be considered for inclusion at discretion of principal investigator, so long as all other eligibility criteria are met
  • LEUKAPHERESIS: Active treatment for prior immune related adverse event to any immunotherapy: Participants receiving ongoing treatment for prior serious immune-related adverse events are excluded, with exception of hormone supplementation or corticosteroid therapy at equivalent of up to 0.5 mg/kg prednisone per day, unless otherwise approved by PI
  • LEUKAPHERESIS: Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Neuropathy related to diabetes or prior chemotherapy is acceptable
  • LEUKAPHERESIS: Uncontrolled pleural effusion, pericardia) effusion, or ascites requiring repeated drainage more than once every 28 days
  • LEUKAPHERESIS: Other medical, social, or psychiatric factor that interferes with medical appropriateness and/or ability to comply with study, as determined by the PI
  • TREATMENT: Corticosteroid therapy at a dose equivalent of > 0.5 mg/kg of prednisone per day
  • TREATMENT: Concurrent use of other investigational anti-cancer agents
  • TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • TREATMENT: Significant underlying neurologic disease: Study participants must not have significant active underlying neurologic disease, unless approved by PI. Neuropathy related to diabetes or prior chemotherapy is acceptable
  • TREATMENT: Uncontrolled pleural effusion, pericardia) effusion, or ascites requiring repeated drainage more than once every 28 days

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I Study of Autologous Transgenic T-Cells Expressing High Affinity Mesothelin-Specific T-Cell Receptor (TCR) (FH-TCR Tᴍsʟɴ) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma

This phase I trial evaluates the side effects and best dose of mesothelin-specific T-cells (FH-TCR-Tᴍsʟɴ) in treating patients with pancreatic ductal adenocarcinoma that has spread to other places in the body (metastatic). Chemotherapy drugs, such as cyclophosphamide and fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading, and may help increase the efficacy from the infused T cells. FH-TCR-Tᴍsʟɴ is an autologous T cell therapy targeting mesothelin, an antigen overexpressed by pancreatic cancer cells. T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize mesothelin, a protein on the surface and inside tumor cells. These mesothelin-specific T cells may help the body's immune system identify and kill mesothelin+ tumor cells. Giving chemotherapy with FH-TCR-Tᴍsʟɴ may kill more tumor cells in the treatment of patients with metastatic pancreatic ductal adenocarcinoma.

Read the detailed description

OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 3 cohorts.

COHORTS I, II and III:

LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide intravenously (IV) and fludarabine IV on days -5, -4 and -3 or may optionally receive bendamustine IV on days -4 and -3 prior to the 1st T cell infusion.

T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.

COHORT IV: (Discontinued with amendment 3/28/23)

LYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1.

T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up to 15 years.

Being tested
Autologous Mesothelin-specific TCR-T Cells, Cyclophosphamide, Fludarabine, Bendamustine
Keywords
Pancreas
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Mesothelin-specific TCR-T CellsBiological

    Receive FH-TCR Tᴍsʟɴ IV

  • CyclophosphamideDrug

    Also called Endoxan, Cytoxan, Neosar, Procytox

    Given IV

  • FludarabineDrug

    Also called Fluradosa, 21679-14-1

    Given IV

  • BendamustineDrug

    Also called SDX-105, 16506-27-7

    Given IV

Study groups in NCT04809766
Study groupRoleWhat they receive
Cohorts I, II, and III (FH-TCR Tᴍsʟɴ)ExperimentalLYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -5, -4 and -3 or may optionally receive bendamustine IV on days -4 and -3 prior to the 1st T cell infusion. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Autologous Mesothelin-specific TCR-T Cells; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine
Cohort IV (FH-TCR Tᴍsʟɴ) (Discontinued with amendment 3/28/23)ExperimentalLYMPHODEPLETION CHEMOTHERAPY: Patients receive cyclophosphamide IV and fludarabine IV on days -3 to -1. T-CELL THERAPY: Patients receive FH-TCR-Tᴍsʟɴ IV over 60-120 minutes on days 0, 21, and 42 in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Autologous Mesothelin-specific TCR-T Cells; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Toxicity (adverse events) will be recorded using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.

    Measured: Up to 4 weeks after the last T cell infusion

  2. Dose limiting toxicities

    Measured: Up to 21 days after each T cell infusion

Secondary outcomes (6)

  1. Overall response rate

    Response will be defined as best overall response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 of complete or partial response. Overall response rates as well as individual categories of response (complete response, partial response, stable disease, and partial disease) will be determined using RECIST 1.1.

    Measured: Up to 1 year after the last T cell infusion

  2. Progression free survival

    Will be estimated using the Kaplan-Meier method, with time zero the time of first T cell infusion.

    Measured: Up to 1 year after the last T cell infusion

  3. Overall survival

    Will be estimated using the Kaplan-Meier method, with time zero the time of first T cell infusion.

    Measured: Up to 1 year after the last T cell infusion

  4. Feasibility of reproducibly generating FH-TCR-Tᴍsʟɴ from autologous patient cells

    Feasibility is defined as the ability to reproducibly generate and infuse the T cells for eligible subjects. The proportion of subjects for which T cells can be isolated, grown, and infused will be estimated as a measure of feasibility.

    Measured: Through last T cell infusion

  5. Stable disease (SD) rate

    Assessed by RECIST 1.1 criteria in treated individuals

    Measured: Up to 1 year after the last T cell infusion

  6. Clinical benefit rate (ORR+SD)

    Assessed by RECIST 1.1 criteria in treated individuals

    Measured: Up to 1 year after the last T cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start14 Dec 2021
  3. Primary completion24 Oct 2024
  4. Study completion15 Jan 2025

Why it stopped: Study terminated due to end of funding.

Resources

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04809766
Sponsor's protocol ID
RG1007292
Other IDs
NCI-2020-08496, 10417
Status last verified
Apr 2025
First submitted
19 Mar 2021
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Mesothelin-specific TCR-T Cells, Cyclophosphamide and Fludarabine in people with Metastatic Pancreatic Ductal Adenocarcinoma and Stage IV Pancreatic Cancer AJCC v8, run by Fred Hutchinson Cancer Center at 1 site 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 32 inclusion and 18 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 2 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 1 site 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study terminated due to end of funding.). Results are not available in the source record.

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?

Incidence of adverse events (time frame: Up to 4 weeks after the last T cell infusion). 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 NCT04809766.

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 2 Jul 2026.

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