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Engineered immune cells take aim at Mesothelin-Positive tumors

NCT ID NCT05451849

Disease control Sponsor: TCR2 Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial tests a new cell therapy called TC-510 for people with advanced cancers that have a protein called mesothelin on their surface, including mesothelioma, ovarian cancer, and pancreatic cancer. TC-510 uses a patient's own immune cells, which are genetically modified to better recognize and attack cancer cells while also turning a cancer defense signal into an activating signal. The study aims to see if this approach is safe and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TC-510 (a genetically engineered T-cell therapy)
What this could lead to
If successful, this could point toward a new treatment option for several hard-to-treat cancers that express mesothelin.
What could go wrong
This is an early-phase trial with only 14 participants, so results may not apply broadly. Cell therapies can cause serious side effects like cytokine release syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

14 people

The number who actually took part.

Started

Jun 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Inability to follow the procedures of the study * Known or suspected non-compliance, drug, or alcohol use

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma colorectal cancer colorectal neoplasm malignant mesothelioma malignant pancreatic neoplasm malignant pleural mesothelioma mesothelioma Mesothelioma, Malignant non-small cell lung carcinoma ovarian adenocarcinoma ovarian cancer ovarian neoplasm ovarian serous adenocarcinoma pancreatic adenocarcinoma pancreatic neoplasm peritoneal mesothelioma pleural mesothelioma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cholangiocarcinoma Colorectal cancer Colorectal neoplasms Mesothelioma Mesothelioma peritoneum Mesothelioma, malignant Mesotheliomas pleural Non small cell lung cancer Ovarian adenocarcinoma Ovarian cancer Ovarian neoplasms Ovarian serous adenocarcinoma Pancreatic adenocarcinoma Pancreatic cancer Pancreatic neoplasms TNBC - triple-negative breast cancer Triple negative breast cancer

Contacts and locations

Locations

  • Montefiore Einstein Cancer Center

    The Bronx, New York, 10461, United States

  • National Cancer Institute

    Bethesda, Maryland, 20814, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • University of California, San Francisco

    San Franciso, California, 94143, United States

  • University of Miami

    Miami, Florida, 33146, United States

  • University of Minnesota, Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States

  • University of Oklahoma

    Oklahoma City, Oklahoma, 73104, United States

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