What is the mechanism of action of this treatment?

Common treatments for Mesothelioma, such as the TC-510 cell therapy, involve targeting specific proteins like Mesothelin that are overexpressed in cancer cells and enhancing T cell activation through mechanisms like the PD-1:CD28 switch receptor. This approach aims to improve the immune system's ability to recognize and destroy cancer cells. Other treatments, such as immune checkpoint inhibitors (e.g., nivolumab and pembrolizumab), block proteins like PD-1 or PD-L1 to prevent cancer cells from evading immune detection. These targeted therapies are crucial for Mesothelioma patients as they offer potentially more effective and less toxic options compared to traditional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for mesothelioma, such as immune checkpoint inhibitors (e.g., nivolumab, pembrolizumab) and traditional chemotherapy, have a range of side effects. Immune checkpoint inhibitors can cause immune-related toxicities, including pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. These side effects can range from mild to severe and may require immunosuppressive treatment. Traditional chemotherapy, often involving agents like pemetrexed and cisplatin, can lead to hematologic toxicities (e.g., neutropenia, anemia), gastrointestinal issues (e.g., nausea, vomiting), and fatigue. The novel TC-510 cell therapy, which targets mesothelin and enhances T cell activation, may share similar immune-related side effects due to its mechanism of action.

What prior FDA approvals exist?

The FDA has approved several treatments for mesothelioma, particularly focusing on immunotherapy. Notably, nivolumab and ipilimumab have been approved for use in malignant pleural mesothelioma, showing promise in clinical trials. These drugs are immune checkpoint inhibitors that enhance T cell activity, similar to the mechanism of TC-510, which targets mesothelin and uses a PD-1:CD28 switch receptor to boost T cell activation. Other immunotherapies, such as pembrolizumab, have also shown activity in mesothelioma treatment, although further investigation is needed.

What other types of research exist?

Promising novel alternatives to TC-510 cell therapy for mesothelioma patients in 2024 include: 1) Nivolumab and ipilimumab combination therapy, which has shown efficacy in clinical trials for relapsed malignant mesothelioma. 2) Pembrolizumab, which has demonstrated clinical activity in patients with malignant pleural mesothelioma. 3) Durvalumab, particularly for patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. These therapies target immune checkpoints and have shown potential in improving outcomes for mesothelioma patients.

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CAR T-cell Therapy

TC-510 Cell Therapy for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by TCR2 Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient is > 18 years of age at the time the Informed Consent is signed

Patient is fit for leukapheresis and has adequate venous access for the cell collection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests TC-510, a therapy using a patient's own modified T cells to target and attack cancer cells. It is aimed at patients with cancers that are hard to treat with standard methods. The modified T cells are designed to recognize specific proteins on cancer cells and get an extra boost to kill them.

Who is the study for?

This trial is for adults over 18 with certain advanced cancers (like mesothelioma, ovarian, pancreatic, colorectal, or triple-negative breast cancer) that express a protein called Mesothelin. Participants should be relatively healthy (ECOG status 0 or 1), have good organ function and no more than five prior systemic therapies for their cancer. They must also be suitable for leukapheresis—a procedure to collect white blood cells.

What is being tested?

The trial tests TC-510 cell therapy in patients with Mesothelin-expressing cancers. It involves modifying the patient's T cells to target cancer cells better using two synthetic constructs: one that recognizes Mesothelin and another that turns off immune suppression signals from tumors.

What are the potential side effects?

Potential side effects of TC-510 may include reactions related to the infusion process, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, and possible autoimmune-like conditions due to altered immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am over 18 years old.

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I am fit for a procedure to collect white blood cells and have good vein access.

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I am healthy enough for a procedure to collect white blood cells and have good veins for it.

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I have been diagnosed with a specific type of cancer such as MPM, ovarian, pancreatic, TNBC, or colorectal.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I've had 1 to 5 treatments for cancer that can't be removed by surgery.

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My tumor shows high levels of MSLN protein.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.

Phase 2 - Disease Control Rate (DCR)

Phase 2 - Overall Response Rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lymphodepletion followed by TC-510Experimental Treatment3 Interventions

Lymphodepletion (fludarabine and cyclophosphamide) followed by TC-510 T cells

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mesothelioma, such as the TC-510 cell therapy, involve targeting specific proteins like Mesothelin that are overexpressed in cancer cells and enhancing T cell activation through mechanisms like the PD-1:CD28 switch receptor. This approach aims to improve the immune system's ability to recognize and destroy cancer cells. Other treatments, such as immune checkpoint inhibitors (e.g., nivolumab and pembrolizumab), block proteins like PD-1 or PD-L1 to prevent cancer cells from evading immune detection. These targeted therapies are crucial for Mesothelioma patients as they offer potentially more effective and less toxic options compared to traditional chemotherapy.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.